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FDA Simultaneous Marketing ANPRM

Bracketed Comment Letter Report

COMMENT NUMBER - 2005N-0345-EC405

2005N-0345-EC405 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kulshrestha, Vikram V

2005N-0345-EC405 - TEXT

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?

<1: 3.1>Yes</1: 3.1>

A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?

<2: 7.5.3>In my opinion, it will not be possible to ensure the misuse.</2: 7.5.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<3: 7.2>No.</3: 7.2>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<4: 8.2>No</4: 8.2>

GENERAL

<5: 8.5.4>It seems practically tricky to control the marketing of the same molecule for same indication in a single package as both prescription & OTC drug. In my personal opinion, a drug (molecule) can be sold as Prescription and OTC product with two different BRAND names. One brand can be marketed as a Prescription drug and the other one as the OTC, thus with two different Packaging. </5: 8.5.4>

<6: 7.5.3>But, the question is ?How the misuse of the same will be prevented by FDA, as the drug will be ultimately available to the subpopulation by a different route ?

So, it is not preferable to market same molecule as both a Prescription and OTC product for same indication.

And it does not seem possible for FDA to enforce a check for limiting the sale of OTC product to a specific population even if the product is labeled for OTC and or Prescription. </6: 7.5.3>

COMMENT NUMBER - 2005N-0345-EC408

2005N-0345-EC408 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Labbe, Carl

2005N-0345-EC408 - TEXT

Issue Areas/Comments

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?

<1: 3.1, 3.8.2>I believe that there are very sound arguements to initiate a rulemaking to define a transitional class of drugs that would be pharmacy-only drugs. Although there is some precedent for concurrent Rx and OTC marketing of drug products, there is much to gained by defining a pharmacy-only class of drugs. Pharmacists already have the skills, knowledge and most importantly, the mechanisms to properly distribute medications based on specific medical and legal criteria.</1: 3.1, 3.8.2>

See above comments

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1>Yes, the section is open to various interpretations.</2: 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.1>Yes</3: 5.1>

<4: 6.2>Not under current rules.</4: 6.2>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.4.1>Again, I suggest letting pharmacies, i.e. pharmacists, manage the distribution of medications that have been Rx and may not quite ready for the broad, unlimited distribution that comes with OTC status in the country.</5: 7.4.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.5.1>As I see it, under current regulations, different labeling is required.</6: 8.5.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 9.1.1>Certain, product-specific information or condition-specific information may need to be presented in different ways to different individual patients.</7: 9.1.1>

GENERAL

<8: 3.8.2, 7.4.1>It is a good time to give careful consideration to creation of a third Pharmacist Only class of medications in this country. Under our current system, medications make a giant leap from the very restricted and regulated prescription distribution system to the incredibly extensive non- prescription marketplace. Making some of these medications so widely available may not be in the best interest of patients' health. Granting pharmacists control over a specific group of prescription medications might serve to improve care in a cost-effective manner. Pharmacists know that they have tremendous impact on their patients' health when they advise and guide the selection and use of medications. Numerous studies have demonstrated the value in both dollars and outcomes when pharmacists are involved in drug therapy management. A third class of drugs would provide consumers with more choices and give them access to professional guidance toward effective health care. Of course, the added benefit would be that pharmacists would enhance the triage function that they already provide, referring patients for physician-provided medical care when indicated. A pharmacist-only class of drugs would be in the best interests of our patients and would have little negative impact on corporate profit margins or on physicians' ability to provide medical care. Actually, there is great potential to broaden the availability of consumer products and enhance the delivery of medical care. This is an idea whose time has finally come. The idea of a pharmacy-only class of drugs is also being considered and may serve as an important transitional step toward a more intelligent distribution system for the myriad of drug products available in this country. Think about the possibilities!

Remember, the purpose of the third class would be to improve access to beneficial medications, not restrict access to OTC products. </8: 3.8.2, 7.4.1>

COMMENT NUMBER - 2005N-0345-EC416

2005N-0345-EC416 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Thompson, Donald

2005N-0345-EC416 - TEXT

Issue Areas/Comments

<1: 1.2.3, 3.1, 3.8.4>Yes. The rulemaking should state that an active ingredient cannot be simultaneously marketed in both prescription and OTC product forms. Either the concerns about biologic safety and regulatory safety are sufficiently low that there is no need for a prescription, or the concerns are sufficiently great to keep it prescription only. Biologic safety issues for estrogens and progesterones have always been enough of a concern that oral contraceptives have been available by prescription only. It seems to be a dilution of regulatory policy and responsibility to permit any estrogen/progesterone product to be available OTC</1: 1.2.3, 3.1, 3.8.4>.

Yes. The rulemaking should state that an active ingredient cannot be simultaneously marketed in both prescription and OTC product forms. Either the concerns about biologic safety and regulatory safety are sufficiently low that there is no need for a prescription, or the concerns are sufficiently great to keep it prescription only. Biologic safety issues for estrogens and progesterones have always been enough of a concern that oral contraceptives have been available by prescription only. It seems to be a dilution of regulatory policy and responsibility to permit any estrogen/progesterone product to be available OTC.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 2.2, 4.1>Yes. I do not understand FDA's interpretation of section 503(b) of the act. I applaud Commissioner Crawford's recognition that regulatory policy issues must consider more issues than simply the scientific safety concerns. Observations of human behavior strongly suggests that alterior motives often lead to misuse and abuse of prescription, OTC, and illegal drugs and other substances, such as Scheduled narcotics, alcohol, and tobacco products, leading to a great degree of pain and suffering. FDA must consider all these issues and issue rules that protect vulnerable populations to the greatest extent possible.</2: 2.2, 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.1>Yes</3: 5.1>. See above.

<4: 6.2, 6.7>No, neither FDA nor state and local authorities would be able to enforce such limitations. Law enforcement and regulatory activities are often low on the priority list for local officials compared to violent crime, so such legal enforcement is very unlikely to occur.</4: 6.2, 6.7>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.2, 7.5.3>I don't see how such a limitation could be enforced. Our nation has a long history of minors getting access to many drugs and substances that are not legal, such as alcohol and tobacco, for which there is only a personal desire for gratification. Prevention of pregnancy with OTC emergency contraception opens the door to sexual predators who could easily purchase the medication OTC, then require their victims to use it. The scientific literature is clear on adolescent decision making processes and risk taking for short term gain. FDA regulatory guidelines must protect this vulnerable population.</5: 7.2, 7.5.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.2, 9.1.1>No. If there is any rational reason for allowing an ingredient to be marketed both by prescription and OTC, the packages must be different, the labels must be different, the warnings must be different, and the limitations on access must be enforceable.</6: 8.2, 9.1.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 9.1.1>Anytime there are biologic or behavioral safely issues associated with access to the products, it would be inappropriate to sell such a product in the same package.</7: 9.1.1>

GENERAL

<8: 1.2.3>Prescription access to emergency contraception does not place an unreasonable burden on its availability. It protects vulnerable young women from sexual abuse and violence, to some degree, and requires all users to consider the possible outcomes of their actions. Healthy behaviors and healthy choices are to be strongly encouraged by our society and our governmental agencies, including responsible diets and exercise, reducing tobacco use, and moderating alcohol use. Increased access to emergency contraception is likely to increase the sexual abuse of vulnerable teenagers, and is unnecessary for responsible persons who are over 18 years of age.</8: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC418

2005N-0345-EC418 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Schulman, Marvin

2005N-0345-EC418 - TEXT

Issue Areas/Comments

<1: 3.9.1>I can find no problem with allowing the same ingredient for both prescription and OTc. I believe this has already been done with many components, the only difference being dose levels. for example, folic acid tablets are OTC but at the 1mg level or higher, they require a prescription </1: 3.9.1>

Yes. I can find no problem with this . please see above

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2>No </2: 4.2>

<3: 6.1>Yes.</3: 6.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<4: 7.1, 7.4.6>Such a requirement is commonly done with cigarettes sold in Pharmacies. Enforcement is left to the local merchant.</4: 7.1, 7.4.6>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<5: 7.5.3, 8.1>Why not. What is the issue here. If it is the same ingredient at the same dose, why would it remain a prescription. Noone will bother to obtain a prescription </5: 7.5.3, 8.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<6: 9.2.2>None</6: 9.2.2>

GENERAL

<7: 4.3.3>I really don't understand the FDA's view of this matter. The issue is much simpler. If a product is safe for OTC sales, it should be available. It is irrelevant, If it also available as a prescription, in the same or a differnt package. </7: 4.3.3><8: 6.6.3>I also believe that few people will seek a prescription if the same product is available OTC. The enforcement issue is bogus. Currently, most pharmacies also sell cigarettes and are required not to sell them to children. The current means of enforcing this rule as well as the one that prevents sale of prescription drugs with a proper prescription should suffice.</8: 6.6.3>

<9: 2.1>It appears to me that the FDA has created some irrelevant issue to stall approval of Plan B because the politics surrounding this drug. It is not the FDA's job to worry about sociol or moral conduct but evaluate drugs and allow useful to available to those who need them. </9: 2.1>

COMMENT NUMBER - 2005N-0345-EC426

2005N-0345-EC426 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Duchon, Kathleen

2005N-0345-EC426 - TEXT

Issue Areas/Comments

<1: 3.1, 3.8.3>Yes, as a consumer and a woman, there should be guidelines as to under 16 years of age use. But, as an adult that option to buy a drug OTC should be available.</1: 3.1, 3.8.3>

<2: 3.1>Yes, times are we a consumer can get a product in illegal ways. Why not make it a safe consumer choice?</2: 3.1>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.2>No, but it does need to be update as the world issues broaden and expand</3: 4.2>

<4: 6.1, 6.6.1>Why not? They have enacted other new procedures such as ID for antihistamines. Why could the same implementation be put into affect for other drugs?</4: 6.1, 6.6.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

see above

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<5: 8.2>No, I would think to clarify the confusion you would have to mandate different packaging.</5: 8.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<6: 9.1.1>When it is given to an under age consumer</6: 9.1.1>

COMMENT NUMBER - 2005N-0345-EC43

2005N-0345-EC43 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Lamermayer, Richard J

2005N-0345-EC43 - TEXT

Issue Areas/Comments

<1: 3.2>No.</1: 3.2> <2: 3.8.8>This would open up pandora's box as there would be a review of dozens (maybe hundreds?) of other molecules that might "need" to be reevaluated as to their prescription/OTC status.</2: 3.8.8>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.2>NO.</3: 4.2> <4: 4.4.2>Although there may SEEM to be so, such confusion is primarily claimed by those who are not entirely familiar with all the circumstances surrounding specific applications of Sec. 503(b).</4: 4.4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<5: 5.2, 5.4.2.2>Further rulemaking would merely open up additional areas of question and urge lawyers and medical personnel to find new avenues for advancing their personal (or constituent) agendas.</5: 5.2, 5.4.2.2>

<6: 6.1>Legally, FDA would probably be able to enforce such a limitation.</6: 6.1> <7: 7.2, 7.5.3, 7.5.4>In practice, this would raise the cost of prescription services and would probably not result in equitable and accurate enforcement.</7: 7.2, 7.5.3, 7.5.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

<8: 7.2>Probably not, as mentioned above</8: 7.2>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<9: 8.2>NO. </9: 8.2><10: 7.5.3>Any violation of the prescription product's sales would be virtually unenforceable from a practical standpoint.</10: 7.5.3>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<11: 6.5.4>If the drug were so HARMLESS as to be sold primarily OTC in the first place. But this begs the question, why sell it by prescription then? </11: 6.5.4>

COMMENT NUMBER - 2005N-0345-EC447

2005N-0345-EC447 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Anspach, Kurt

2005N-0345-EC447 - TEXT

Issue Areas/Comments

<1: 3.3.3>If it were safe to take theses pills without a prescription in one form then how can it not be for another use?Thats a double standard.Most of the population that will be taking these pills won't understand that this shouldn't be done without being advised and supervised by a Doctor.</1: 3.3.3><2: 7.5.3>There wouldn't be any control over who buys these pills.Why fool ourselves saying lets put a age limit on them.After all is possible to purchased anything at any time.</2: 7.5.3>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.5>Parts of the statement is good but how many people know the process of filing a complaint?This issue is a very important issue and it should be brought to the attention of the population throught the media.</3: 4.5>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.2>no!</4: 5.2><5: 5.4.2.2> If there was a rulemaking how would the people know were to look for it?How many people know to go on the FDA website?</5: 5.4.2.2>

no It wouldn't make any difference if the person wants them they will get them.

GENERAL

see attachment

2005N-0345-EC447-Attach-1.PDF 2005N-0345-EC447-Attach-1.PDF 2005N-0345-EC447-Attach-1.PDF 2005N-0345-EC447-Attach-1.PDF 2005N-0345-EC447-Attach-1.PDF

ATTACHMENT:

<6: 1.2, 10>IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

CIVIL ACTION No. 05-810

MELISSA ANSPACH, KURT A. ANSPACH, KAREN E. ANSPACH,

Plaintiffs,

CITY OF PHILADELPHIA, DEPARTMENT OF PUBLIC HEALTH, et al,

Defendants.

MEMORANDUM AND ORDER

JOYNER, J. June 27, 2005

Via the instant Motion, Defendants John F. Domzaliski, Louise Lisi, Maria Fedorova, Mary Gilmore, and the City of Philadelphia move to dismiss Plaintiffs' Complaint. Because Plaintiffs have failed to state a claim under federal law, this action must be dismissed for lack of federal question jurisdiction.

Factual Background

On January 26, 2004, Plaintiff Melissa Anspach visited a Health Center operated by the City of Philadelphia Department of Public Health. Melissa, who had engaged in sexual activity on January 23, 2004, believed that she might be pregnant and requested a pregnancy test. Plaintiffs allege that Melissa was told by a receptionist that she could not obtain a pregnancy test "because it was not family planning day." Melissa left the Health Center, but returned shortly thereafter at the prompting of a friend, who told Melissa to "ask for the morning after pill." Melissa followed this advice and was directed to the pediatric ward, where she provided her name and date of birth, indicating that she was sixteen years of age. See Complaint, ¶ 22-26.

Plaintiffs allege that Melissa next spoke with Defendant Maria Fedorova, a social worker, for approximately ten minutes, during which they discussed sexually transmitted diseases, birth control, and emergency contraception. Ms. Federova allegedly told Melissa that the Health Center could provide pills "that would prevent [her] from getting pregnant," and Melissa agreed to take these pills. Defendant Mary Gilmore, a registered nurse, then took Melissa's temperature and blood pressure, and provided Melissa with emergency contraception marketed under the trade name Nordette. [Footnote 1: This method of emergency contraception, also known as the "morning-after pill," uses a combination of progestin and estrogen to prevent pregnancy. Depending on the phase of the patient's menstrual cycle, emergency contraception may prevent ovulation or fertilization. If fertilization has already occurred, emergency contraception may alter the endometrium to prevent implantation of the fertilized egg. If a fertilized egg has already implanted in the endometrium, emergency contraception will have no effect. See http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm.] Nurse Gilmore told Melissa to take four pills right away and then four more in twelve hours. Plaintiffs contend that before Melissa took the pills, Nurse Gilmore consulted with Ms. Federova "to find out how Melissa should take the pills," and consulted with Defendant Jitendra Shah, a physician, to ask if Dr. Shah wanted to examine Melissa. After Melissa took the pills in Defendant Gilmore's presence, she allegedly asked whether the pills would make her sick. Nurse Gilmore reportedly consulted with Dr. Shah once again, who advised Nurse Gilmore to tell Melissa to drink ginger ale. See Complaint, ¶ 26-34.

After taking her second dose of pills at approximately 4:00 A.M. on the morning of January 27, 2004, Melissa experienced severe stomach pains and began vomiting. Melissa's father, Plaintiff Kurt Anspach, came to her room and found Melissa lying on the floor. Mr. Anspach contends that Melissa's face was swollen and red, and that Melissa asked if she was going to die. Upon learning that Melissa had taken emergency contraception, Mr. Anspach called their family physician and the poison control center, and took Melissa to the emergency room. Melissa was released from the hospital the same day, but returned because of sub-conjunctive hemorrhaging in her eye resulting from excessive vomiting. Melissa Anspach and her parents contend that the events described above have caused them to suffer severe emotional distress. See Complaint, ¶ 35-38.

Plaintiffs bring the instant action against Defendants, maintaining that their state and federal Constitutional rights were violated as a result of Defendants' actions. Mr. and Mrs. Anspach contend that they were deprived of their right to familial privacy when Defendants provided Melissa with medication without her parents' consent. Similarly, Melissa contends that Defendants' actions deprived her of the opportunity for parental consultation and guidance. She has also raised a claim of assault and battery against Defendants Federova and Gilmore for dispensing medication without Melissa's informed consent. Melissa contends that she was told that emergency contraception would prevent her from becoming pregnant, but was never informed that the pills could cause miscarriage or termination in the event she was already pregnant. Plaintiffs further bring claims of negligent supervision against Dr. Shah, and negligent and intentional infliction of emotional distress against the individual Defendants.

Standard of Review

In considering a motion to dismiss, a court must consider only those facts alleged in the complaint and accept all of the allegations as true. Morse v. Lower Merion Sch. Dist., 132 F.3d 902, 906 (3rd Cir. 1997). However, the court need not credit the plaintiff's "bald assertions" or "legal conclusions" where such conclusions are unsupported by the pleadings. Morse, 132 F.3d at 906. A motion to dismiss may only be granted where the plaintiff's allegations fail to state any claim upon which relief could be granted. Morse, 132 F.3d at 906.

Discussion

To state a cause of action for state deprivation of a constitutional right, a plaintiff must allege that he was deprived of a federal right by a defendant acting under color of state law. 42 U.S.C. § 1983; Gomez v. Toledo, 446 U.S. 635, 640 (1980). In Count I, Mr. and Mrs. Anspach contend that they were deprived of their fundamental right to direct the rearing and education of their minor child as a result of Defendants' course of conduct. In Count II, Melissa Anspach alleges that Defendants deprived her of her right to parental guidance and advice in matters relating to medical care. Both counts arise out of the liberty interests granted by the Due Process Clause of the Fourteenth Amendment. Plaintiffs also allege that Defendants violated their First Amendment right to free exercise of religion by providing Melissa with a medication that can cause termination of a pregnancy, defined under Pennsylvania law as commencing with fertilization. 18 Pa. C.S. 3203.

I. Rights of Parental Guidance and Familial Privacy

It is well established that the fundamental right of parents to direct the upbringing and education of their children is protected by the Due Process Clause of the Fourteenth Amendment. Troxel v. Granville, 530 U.S. 57, 65 (2000); Wisconsin v. Yoder, 406 U.S. 205, 232 (1972); Prince v. Massachusetts, 321 U.S. 158, 166 (1944); Pierce v. Society of Sisters, 268 U.S. 510, 534-35 (1925). This right, however, is not absolute. The state has a wide range of power to limit parental freedom in matters relating to child welfare. Prince, 321 U.S. at 167. Furthermore, the right of a parent to direct a child's upbringing cannot be understood in isolation. Minors, as well as adults, are protected by the Constitution and possess fundamental rights that may in some instances outweigh those possessed by their parents. Carey v. Population Servs. Int'l, 431 U.S. 678, 692 (1977) (quoting Planned Parenthood of Central Missouri v. Danforth, 428 U.S. 52, 74 (1976)).

A. No State Interference with Parent-Child Relationship

Even viewing the facts of the Complaint in their most favorable light, Plaintiffs have failed to state a valid claim for relief arising from violation of the above-described parental rights. Plaintiffs maintain that when Melissa Anspach visited the Health Center, Defendants were aware that she was only sixteen, but never asked Melissa whether her parents knew of her predicament, nor advised her to consult with her parents before deciding whether to take emergency contraception. Complaint, ¶ 27, 28. In Counts I and II of their Complaint, Plaintiffs conclude that Defendants' course of conduct "was intended to influence Melissa to refrain from discussing with her parents her possible pregnancy and what course of conduct was appropriate," and violated Mr. and Mrs. Anspach's rights "by usurping the parental role." Id., ¶ 67, 68, 72, 77. This Court cannot credit Plaintiff's legal conclusions, however, as they are entirely unsupported by the factual allegations in the Complaint concerning Melissa's interaction with the Health Center staff. Plaintiffs do not maintain that Defendants instructed Melissa not to consult with her parents or otherwise prevented her from seeking their guidance and advice with respect to reproductive matters. At best, Plaintiffs have alleged only that Defendants failed to encourage Melissa to seek her parents' assent. Such passive failure on the part of a state agency and its employees cannot form the basis of a constitutional claim of the kind raised by Plaintiffs.

In the key cases defining the scope of the fundamental parental right to control a child's rearing and education, the Supreme Court has held that a state may not forbid parents from educating their children in accordance with their beliefs. See Yoder, 406 U.S. at 232-34 (compulsory high school education as applied to Amish minors); Pierce, 268 U.S. 510, 534-35 (compulsory education within the public school system); Meyer v. Nebraska, 262 U.S. 390, 400 (1923) (statute prohibiting teaching of foreign languages). Plaintiffs have identified no authority, however, to suggest that the scope of these cases can be expanded to allow constitutional claims against states that permit parental involvement but merely fail to take steps to encourage more active parental participation. This fundamental legal distinction was highlighted in 1980 by the Sixth Circuit Court of Appeals, in connection with a challenge to the Michigan Health Department's provision of contraceptive information and services to minors without parental notification. Doe v. Irwin, 615 F.2d 1162, 1168 (6th Cir. 1980), cert. denied, 449 U.S. 829 (1980). The Sixth Circuit found that earlier Supreme Court cases dealt only with states "either requiring or prohibiting some activity." Id. In contrast, the state of Michigan, in establishing a voluntary birth control clinic, "imposed no compulsory requirements or prohibitions" affecting the rights of the parent- plaintiffs. Id. The court explained its findings as follows:

There is no requirement that the children of the plaintiffs avail themselves of the services offered by the Center and no prohibition against the plaintiffs' participating in decisions of their minor children on issues of sexual activity and birth control. The plaintiffs remain free to exercise their traditional care, custody and control over their unemancipated children. Id.

We find the Sixth Circuit's interpretation of Supreme Court precedent on the issue of parental rights to be compelling. See also Parents United for Better Schs. Inc. v. Sch. Dist. of Pa. Bd. of Educ., 148 F.3d 260, 276 (3rd Cir. 1998) (favorably citing the reasoning of Irwin in upholding a voluntary condom distribution program in Philadelphia schools). In establishing a voluntary health clinic, the state of Pennsylvania has neither required that minors within the Commonwealth avail themselves of its services, nor prohibited parents from participating in their children's educational, moral, or physical upbringing. Thus, Plaintiffs have failed to state a constitutional claim for violation of Mr. and Mrs. Anspach's right to direct the upbringing of their minor child, Melissa. For the same reasons, Plaintiff Melissa Anspach has failed to state a constitutional claim for violation of her right to receive parental guidance.

B. No Parental Right to Be Notified of a Minor Child'sExercise of Reproductive Privacy Rights

Even if Plaintiffs' Complaint did allege facts sufficient to support a finding that Defendants' actions prevented Mr. and Mrs. Anspach from counseling their daughter, there is an alternative ground for dismissal of Plaintiffs' claims. There is simply no constitutional basis to support Plaintiffs' contention that parents have a constitutional right to be informed of their minor child's request for family planning services.

Minors, as well as adults, have a fundamental right to privacy in the intimate area of reproductive decision-making. See Carey, 431 U.S. at 692 (citing Danforth, 428 U.S. at 74). States that have adopted policies aimed at protecting this privacy right, however, often face challenges from parents alleging intrusion upon the sphere of familial privacy and parental guidance. In Danforth, for example, the Supreme Court considered the interplay between the reproductive rights of minors and the rights of their parents in the context of a Missouri law requiring parental consent to abortion for minors. Danforth, 428 U.S. at 74-75. Finding the absolute parental consent requirement unconstitutional, the Court held that a parent's independent interest in terminating or continuing a minor daughter's pregnancy is "no more weighty than the right of privacy of the competent minor mature enough to have become pregnant." Id. at 75. In a plurality opinion the following year, the Supreme Court found that the decision in Danforth "a fortiori foreclosed" any absolute prohibition on the distribution of contraceptives to minors without parental consent. Carey, 431 U.S. at 694. Thus, to the extent that Plaintiffs object to Defendants' failure to obtain the consent of Mr. and Mrs. Anspach before prescribing emergency contraception to Melissa Anspach, their constitutional claims must fail as a matter of law.

To the extent that Plaintiffs seek recovery on the basis of Defendants' failure to notify Melissa's parents of her request for emergency contraception, their claim must fail as well. There is absolutely no authority before this Court to support the proposition that a parent's right to be notified that their child has sought out family planning services outweighs the minor child's interest in reproductive privacy.

While the Supreme Court has upheld the constitutionality of parental notice requirements under some circumstances, the Court has never held that parents have a constitutional right to such notification, either with respect to contraception or abortion. [Footnote 2: Plaintiffs contend that the standards governing abortion should govern discussion of emergency contraception, because emergency contraception can result in the termination of a pregnancy, defined under Pennsylvania law as a fertilized embryo. See 18 Pa. C.S. 3203. This Court declines to determine whether emergency contraception is closer in kind to traditional methods of birth control or to chemically-induced abortion. For this reason, we will consider the law governing parental notification in the context of both abortion and contraception.] See, e.g., Lambert v. Wicklund, 520 U.S. 292, 297-98 (1997) (per curiam); Ohio v. Akron Ctr. for Reproductive Health, 497 U.S. 502, 510-11 (1990); H.L. v. Matheson, 450 U.S. 398, 409-10 (1981); See also Irwin, 615 F.2d at 1169 (finding that the opinions in Carey do not indicate that parents have a constitutional right to notification). Rather, the language used by the Supreme Court suggests that parental notification requirements pose significant constitutional challenges, and may be struck down if they do not provide minors seeking abortions with opportunities for exemption or judicial bypass. [Footnote 3: The Supreme Court has similarly held that statutes imposing an absolute requirement of parental consent are unconstitutional, finding that the failure to provide judicial bypass or other exemption procedures imposes an undue burden on a minor's right to choose. See Ohio v. Akron Center for Reproductive Health, 497 U.S. at 511; City of Akron v. Akron Center for Reproductive Health, 462 U.S. 416, 440 (1983); Bellotti v. Baird, 443 U.S. 622, 651 (1979) (plurality).] See, e.g.,Hodgson v. Minnesota, 497 U.S. 417, 450-55, 461 (1990) (finding Minnesota's two-parent notice statute unconstitutional without procedures for judicial bypass); Lambert, 520 U.S. at 297-98 (upholding Montana notice statute with judicial bypass procedure); Ohio v. Akron Ctr. for Repro. Health, 497 U.S. at 510-11 (applying Bellotti bypass procedures to uphold Ohio notice statute); Matheson, 450 U.S. at 409 (upholding Utah parental notification law as applied to an immature, unemancipated minor seeking abortion); See also Planned Parenthood v. Heed, 390 F.3d 53 (1st Cir. 2004); Planned Parenthood of the Rocky Mts. Servs. Corp. v. Owens, 287 F.3d 910 (10th Cir. 2002); Planned Parenthood v. Miller, 63 F.3d 1452 (8th Cir. 1995).

Furthermore, numerous courts have held that parental notice requirements in the context of contraception and family planning services are inconsistent with Title X, which imposes a burden of confidentiality on providers of such services. 42 C.F.R. § 59.11; See, e.g., County of St. Charles v. Missouri Family Health Council, 107 F.3d 682, 684-85 (8th Cir. 1997); New York v. Heckler, 719 F.2d 1191, 1196-97 (2nd Cir. 1983); Planned Parenthood Fed. of Am. v. Heckler, 712 F.2d 650, 656-61 (D.C. Cir. 1983).

In light of the above authorities, Plaintiffs are wrong to suggest that they have a constitutional right to be notified of their daughter's request for emergency contraception. Thus, Counts I and II fail to state valid constitutional claims.

II. Right to Free Exercise of Religion

Plaintiffs also maintain that Defendants violated their right to free exercise of religion by providing Melissa with a medication that can cause termination of a pregnancy. Although the parties have not briefed this issue, this Court finds that Plaintiffs have failed to state a valid cause of action for violation of their rights under the Free Exercise Clause of the First Amendment.

In merely alleging that Defendants "gave [Melissa] a substance that, in some cases, may result in the termination of a pregnancy," and that Melissa would not have taken the pills had she known of this potentiality, Plaintiffs have failed to plead any constitutionally relevant injury in fact. See Complaint, ¶ 74, 80. Plaintiffs do not allege that Melissa was pregnant at the time she took the emergency contraception, nor do they allege that Defendants' actions actually resulted in the termination of a pregnancy in violation of Melissa's religious beliefs.

Furthermore, the facts of the Complaint, viewed in the light most favorable to Plaintiffs, do not suggest that Defendants "placed a substantial burden on [Plaintiffs'] observation of a central religious belief or practice." See Hernandez v. Commissioner, 490 U.S. 680, 699 (1989). Plaintiffs admit that Melissa voluntarily requested "the morning after pill," and do not allege that she made any inquiries as to the effect of emergency contraception on a fertilized ovum. Rather, Plaintiffs merely contend that Melissa was misled by the designation "emergency contraception" in the literature provided by the Department of Health. Moreover, Plaintiffs do not maintain that Defendants compelled Melissa to take the pills, or otherwise prevented her from consulting with her parents or religious advisors regarding the implications of her decision.

Finally, it is well established that parental liberty interests are not violated merely because religious beliefs are implicated in the claim. Irwin, 615 F.2d at 1168 (citing Prince, 321 U.S. at 166).

Conclusion

This Court recognizes that parental guidance is invaluable to a child's moral, social, and religious development. Parental involvement is particularly important during the period of adolescence, when children struggle with weighty issues of peer pressure and sexuality. Within any family unit, parents and their adolescent children have a shared responsibility to engage in discussion of personal and family values, and to learn from each other's perspectives. These ideals are reflected in the Due Process Clause of the Fourteenth Amendment, which protects the fundamental right of parents to direct the upbringing and education of their children.

Plaintiffs interpret this parental right to require that public health centers disclose to parents a minor child's request for family planning services. In doing so, Plaintiffs stretch the boundaries of this constitutional doctrine to the breaking point. The Health Center's failure to notify Mr. and Mrs. Anspach of their daughter's request for emergency contraception in no way prevents Plaintiffs from discussing responsible sexual activity or religious doctrine at home. Furthermore, Mr. and Mrs. Anspach's rights under the Due Process Clause do not include the right to receive state notification upon their minor daughter's exercise of her fundamental right to privacy in reproductive decision-making.

In sum, Plaintiffs' allegations fail to state any constitutional claim upon which relief could be granted. As there is no federal question remaining before this Court, this action shall be dismissed for lack of jurisdiction.

An appropriate Order follows.

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

CIVIL ACTION No. 05-810

MELISSA ANSPACH, KURT A. ANSPACH, KAREN E. ANSPACH,

Plaintiffs,

CITY OF PHILADELPHIA, DEPARTMENT OF PUBLIC HEALTH, et al,

Defendants.

ORDER

AND NOW, this 27th day of June, 2005, upon consideration of the Motion to Dismiss filed by Defendants John F. Domzaliski, Louise Lisi, Maria Fedorova, Mary Gilmore, and the City of Philadelphia (Doc. No. 6), and Plaintiffs' response thereto (Doc. No. 14), it is hereby ORDERED that the Motion is GRANTED and this action is dismissed for lack of subject matter jurisdiction.

BY THE COURT,

s/J. Curtis Joyner

J. CURTIS JOYNER, J.</6: 1.2, 10>

COMMENT NUMBER - 2005N-0345-EC47

2005N-0345-EC47 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Clason, Dennis

2005N-0345-EC47 - TEXT

<1: 6.1, 6.6.3>It seems rather clear that both State and Federal bodies regulate and enforce product restrictions to particular subpopulations. The legal age for alcohol consumption is 21 years in all 50 states, and this age limit is enforced by both the various States and by Federal agencies (e.g., Department of Defense). Many States have laws and regulations which control the distribution of tobacco products to those over an age limit, and they are able to enforce their laws and regulations. Other substances controlled in similar ways include inhalants (toluene-containing glues and aerosols) and spray paints.

Clearly, if it is permissible for State and Federal agencies to restrict distribution of certain compounds by age, it is both permissible and possible for the FDA to do so.</1: 6.1, 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<2: 7.1, 7.4.4, 7.4.5>Of course it is. Age limits can be enforced for new drugs in the same way they are enforced for casually used drugs like nicotine and ethanol. Spot check purchase attempts by individuals who appear to be underage and have an underage ID would suffice to control distribution. The FDA can set appropriate fines and penalties for violation of the distribution rules it sets up.</2: 7.1, 7.4.4, 7.4.5>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<3: 9.1.1>If the indications were different for the OTC and prescription products, I would expect that different packaging would be required and reasonable.</3: 9.1.1> <4: 8.4.1, 9.2.1>If the indications are the same for the OTC and prescription product, then I think that differentiated packaging is silly.</4: 8.4.1, 9.2.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

See above.

GENERAL

<5: 1.2, 2.1>This is without a doubt one of the silliest and most blatantly political exercises the FDA has ever engaged in. The political appointees in the Agency really ought to quit playing footsie and make a decision on the Barr application -- approve it, or disapprove it, but follow your own rules regarding applications. </5: 1.2, 2.1>

COMMENT NUMBER - 2005N-0345-EC49

2005N-0345-EC49 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Landauer, Christopher

2005N-0345-EC49 - TEXT

Issue Areas/Comments

<1: 1.2.3>The FDA has a responsibility to determine what medications can be safely self admisnistered. However in this case, the use of the medication will set a precedent that will be unheard of. There are ample methods of contraception available in the marketplace and there is no reason for a medication of this nature. It was uncontionable that the agency ever approved a medication of this nature in the first place, but now that it is approved, it should remain a perscription drug that doctors should only perscribe on a case by case basis.

I would hope that the agency would be responsible to ensure that this madication and any others like it remain perscription drugs.</1: 1.2.3>

<2: 6.2, 6.5.1, 7.2, 7.5.2>No, the agency does not have the capacity to enforce a perscription program to any subpopulation. The agencies responsibility is to ensure that only safe, ethical drugs are allowed in the marketplace. The agency does not have the ability to enforce age limitations with respect to perscription drugs. Hence this drug product should only be perscribed by a medical professional.</2: 6.2, 6.5.1, 7.2, 7.5.2>

B. If it could, would it be able to do so as practical matter and, if so, how?

<3: 7.5.1>No the agency does not have the authority to comply w/ this.</3: 7.5.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<4: 1.2.3>This product should never be sold over the counter. That would be negligent of the agency to allow something like that to happen.</4: 1.2.3>

GENERAL

<5: 1.2.3>I think the agency is putting itself on a slippery slope with the decision on this issue. I think it would remain in the best interest of the general public to keep this and other medications as perscription drugs. This way a trained professional can make a rationale decision on the availability of this product.

This product does not have much redeeming value in general. </5: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC495

2005N-0345-EC495 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Stier, Christopher

2005N-0345-EC495 - TEXT

Yes. While the current interpretation seems reasonable, a lack of codification leaves open a great deal of subjectivity with respect to what is meant by a "meaningful difference" between a prescription product and an OTC product. This codification should go beyond simple differences (e.g., strength, dosage) and require that clinical trials form the basis for any OTC branding - in order to ensure the safety of the population or any subpopulation for which the OTC version is being made available.

<1: 3.1>Yes.</1: 3.1> <2: 3.8.1, 3.11>While the current interpretation seems reasonable, a lack of codification leaves open a great deal of subjectivity with respect to what is meant by a "meaningful difference" between a prescription product and an OTC product. This codification should go beyond simple differences (e.g., strength, dosage) and require that clinical trials form the basis for any OTC branding - in order to ensure the safety of the population or any subpopulation for which the OTC version is being made available.</2: 3.8.1, 3.11>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.1>Yes - to a degree.</3: 4.1> <4: 4.3.4>The interpretation is sound. However, there is confusion due to the lack of a documented "decision tree" around the process of FDA approval for the sale of an OTC product.</4: 4.3.4>

C. If so, would a rulemaking on this issue help dispet that confusion?

<5: 5.1>Yes.</5: 5.1> <6: 5.3.2>Document the "meaningful difference" for drug manufacturers and consumers. This will diffuse the effects of marketing, advertising, and labels that can be highly misleading. Men and women deserve to know the truth about drugs being marketed to them.</6: 5.3.2>

<7: 6.3.5>The answer would clearly depend on how the subpopulation was classified. Age restrictions, for example, could be enforced as a matter of law. </7: 6.3.5>

B. If it could, would it be able to do so as practical matter and, if so, how?

<8: 7.1, 7.4.4>Yes. Minors are not permitted to buy alcohol without proper ID showing proof of age. </8: 7.1, 7.4.4>

COMMENT NUMBER - 2005N-0345-EC5

2005N-0345-EC5 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Cunningham, Laura

2005N-0345-EC5 - TEXT

Issue Areas/Comments

<1: 3.1>YES</1: 3.1>

YES

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1>YES</2: 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.1>YES</3: 5.1>

<4: 7.1, 7.4.4>YES, BY MAKING STORES CHECK IDENTIFICATION BEFORE PURCHASE, JUST AS THEY DO WITH CIGARETTES AND ALCOLHOL. CASH REGESTERS AUTOMATICALLY STOP A SALE AND ASK FOR THE CUSTOMERS DATE OF BIRTH. </4: 7.1, 7.4.4><5: 7.4.1>PUTTING THEM BEHIND A PHARMACY COUNTER WOULD MAKE THEM AS INACESSABLE THEY WERE BEFORE BECAUSE PHARMACISTS WOULD THEN NOT DISTRIBUTE THEM DUE TO RELIGIOUS BELIFES.</5: 7.4.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.4.4>BY MAKING CASH REGISTERS CHECK DATE OF BIRTH</6: 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.1, 8.3.4>YES,WITH A DISCLOSURE</7: 8.1, 8.3.4>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<8: 9.1.1>IF THERE WAS A DIFFERENCE IN PRODUCT INGREDIENTS</8: 9.1.1>

GENERAL

<9: 1.2.1>PUT THIS PRODUCT ON THE SHELF SO WOMEN MAY DECIDE FOR THEMSEVES WHAT IS RIGHT FOR THEM.</9: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC505

2005N-0345-EC505 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Padden, Phillip

2005N-0345-EC505 - TEXT

<1: 3.7.1>Check your congressional mandate. If it requires that interpretations be justified then yes, codifying your interpretation would be an extension of justification.</1: 3.7.1>

Again, Check your congressional mandate. If it requires that interpretations be justified then yes, codifying your interpretation would be an extension of justification.

<2: 6.2, 6.5.4>No, but as a matter of law all America's should have equal access to drugs without any government restrictions/prohabitions. The constitutions allows for the regulation of interstate trade, not the restriction of it.</2: 6.2, 6.5.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

<3: 7.1, 7.4.4>Yes, follow the example of alchol and tobacco age restrictions.</3: 7.1, 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<4: 8.1>Yes</4: 8.1>

GENERAL

<5: 1.2.1>The release of Plan B as an OTC, should not be held up or restricted, of a young woman's access to the drug. </5: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC516

2005N-0345-EC516 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Katrib, Elise

2005N-0345-EC516 - TEXT

<1: 1.2.2>Yes it should allow Plan B to be available both in prescription and OTC drug form. But given that the pharmacists are allowed to choose which prescription you are allowed to receive, the OTC drug should marketed heavily.</1: 1.2.2>

<2: 1.2.2>As long as the active ingredient is safe, market in both a prescription drug product and an OTC drug product.</2: 1.2.2>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.1, 4.5>Yes, it seems that given enough pressure or money, a drug will be able to overcome FDA interpretation of any act.</3: 4.1, 4.5>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 3.8.3>The rulemaking should focus on safety. But also take into account that the same drug is widely available in other countries such as Canada and the Britain.</4: 3.8.3>

<5: 6.1>Yes it is possible to sell to a subpopulation.</5: 6.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 6.6.3, 7.4.4>How do we enforce the sale of tobacco and alcohol? Just check ID.</6: 6.6.3, 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.1>Yes</7: 8.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<8: 9.2.1>They may be sold in a single package if they have the same active ingredients.</8: 9.2.1>

GENERAL

<9: 1.2.1>I support the OTC version of the Plan B drug. I am actually surprised that the FDA is taking a longer time to examine this drug then others that have been declared safe to be sold as OTC drugs. I believe that the Plan B drug sold as an OTC will resolve many instances of conflict in pharmacies, regarding the right to have a valid prescription filled. I will keep checking for updates regarding this issue. </9: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC518

2005N-0345-EC518 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kowalczyk, Brigid

2005N-0345-EC518 - TEXT

<1: 1.2.3>The morning after pill, which is potentially an abortifacent drug, should not be sold over the counter to anyone. It is a serious drug with a serious use that should not be trivialized by selling it to anyone who thinks they need it. There is no way to limit its application and avoid abuses which will be very damaging to the health of the women who take it as well as potentially causing an abortion, which is its only intent.</1: 1.2.3>

<2: 1.2.3>the active ingredient in the morning after pill should not be allowed to be sold over the counter for any reason. If it is available by prescription there is some control over who decides to take it, some oversight to the application. OTC drugs can be and will be abused and used incorrectly often.</2: 1.2.3>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.1>there is significan confusion. </3: 4.1><4: 4.5>No drug should be sold both by prescription and OTC.</4: 4.5>

C. If so, would a rulemaking on this issue help dispet that confusion?

<5: 5.1>Yes.</5: 5.1>

<6: 1.2.3>How could that work? What subpopulation? Who decides who that "subpopulation" is? Only prostitutes? Only teenagers under the age of 18? Only women between 18-24? Ridiculous. The decision to us MAP is a decision to take a drug to eliminate a condition. That condition is merely pregnancy, a normal natural consequence of intercourse. We do not recommend laxatives and bulimia and extreme exercise for overweight people who are also suffering the consequences of their act of eating, too much or the wrong things. But those items (laxatives) can be abused becasue they are OTC and we have no control over them. But that person is only hurting themselves. Someone who takes an OTC MAP will be hurting themselves and also removing a conceived embryo from the planet. This hurts the child (embryo is a child) and the planet and the effects of the OTC hormone will also hurt the woman who takes it.</6: 1.2.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<7: 1.2.3>I answer questions, on a website, that come from young women who "accidently" have sex with someone and not knowing where they are in their cycle or how likely it is that pregnancy could result, ask me if they should get MAP. And then if they "accidently" do it again 2 or 5 days later, they ask the same question again! So many women, because they are scared (and doing the wrong thing) are going to think this saves them. They are going to think they are safe if they just do whatever they want and then take the MAP, especially if it's available OTC.</7: 1.2.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<8: 8.2, 8.6.4>How confusing is that? One girl goes to her doctor and gets a prescription, the other goes to the local drug store and picks up the same box! One girl has some medical supervision in case there are adverse reactions (abortion is an adverse reaction but that won't be considered) and the other is on her own to consider her symptoms without any medical opinion to guide her. That's a good idea! NOT.</8: 8.2, 8.6.4>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<9: 9.1.2>All circumstances. Neither should be sold but if it will be sold and marketed (that's where the problem comes) then it should be something that women consider to be a serious drug with serious side effects, not something like Sudafed or antacids that anyone can pick up at any time without a medical diagnosis!</9: 9.1.2>

COMMENT NUMBER - 2005N-0345-EC52

2005N-0345-EC52 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Zahn, Steven

2005N-0345-EC52 - TEXT

<1: 3.1>Yes.</1: 3.1>

Yes.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1>Yes.</2: 4.1> <3: 4.5>It is not significant enough that different strengths of the same product are marketed as prescription or OTC. That gives the illusion of safety in taking increased doses of the OTC product knowing that there is an equivalent prescription dose available.</3: 4.5>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 6.1>Yes.</4: 6.1>

<5: 6.2>No, not under the current regulations and its interpretations.</5: 6.2>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.2>No. </6: 8.2><7: 8.6.2>There would be too much confusion among packaging, leading too errors in dispensing the wrong products or packaging.</7: 8.6.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<8: 9.1.2>All circumstances. The OTC product would have the same potential for harm from misuse, or circumstances surrounding its use, in one subpopulation as in another.</8: 9.1.2>

GENERAL

<9: 3.11>It is not significant enough that different strengths of the same product are marketed as prescription or OTC. That gives the illusion of safety in taking increased doses of the OTC product knowing that there is an equivalent prescription dose available. The safety of all market strengths available of a particular product should be considered when evaluating a product's safety for OTC use. Also, limiting OTC sales of a product to population subgroups still exposes that subpopulation to possible harmful effects or cirucmstances due to misuse of the product. Potentiality of harmful effect of a product can also be realised from the circumstances in which a product is used, and not just toxicities from the product itself.</9: 3.11>

COMMENT NUMBER - 2005N-0345-EC522

2005N-0345-EC522 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dolinski, Elizabeth

2005N-0345-EC522 - TEXT

Issue Areas/Comments

<1: 1.2.2, 3.2, 3.8.8>The FDA should only rule on drug safety issues. I am very upset that the FDA is trying to pass moral judgement on the U.S. population. It has been determined to be medically preferable to make plan b available simultaneously available. Therefore, that is what the FDA should do.</1: 1.2.2, 3.2, 3.8.8>

The FDA should only rule on drug safety issues. I am very upset that the FDA is trying to pass moral judgement on the U.S. population. It has been determined to be medically preferable to make plan b available simultaneously available. Therefore, that is what the FDA should do.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.3.2>the FDA CAN make a drug both prescription and over the counter. That is clear to me and should be made clear to the public.</2: 4.3.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.5>the FDA CAN make a drug both prescription and over the counter. That is clear to me and should be made clear to the public.</3: 5.5>

<4: 6.7>the FDA has no right to make an OTC drug available only to a subpopulation. The only subpopulation separate the FDA has a right to regulate is minor versus adult.</4: 6.7>

B. If it could, would it be able to do so as practical matter and, if so, how?

The only subpopulation separate the FDA has a right to regulate is minor versus adult.

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<5: 8.1>YES, of course. </5: 8.1><6: 8.4.1>To require different packaging would raise the price for no good purpose.</6: 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 8.7, 9.1.1>For the same dose, it should always be appropriate. The ONLY reason it wouldn't be appropriate was if higher dosages were to be prescription. I.e. for ibruprofen.</7: 8.7, 9.1.1>

GENERAL

<8: 1.2.2, 2.1>I am deeply offended by the delay of approval of plan b. Why would the FDA want to take action that drives up the number of risky operations (abortions) for young women? especially when there is a safe contreceptive alternative? does the FDA intend to purposefully injure young women with this action?</8: 1.2.2, 2.1>

COMMENT NUMBER - 2005N-0345-EC526

2005N-0345-EC526 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Thompson, Sharon

2005N-0345-EC526 - TEXT

Issue Areas/Comments

<1: 6.2, 7.5.3>It would not be possible to regulate having "prescription" status for a particular subpopulation because it would be too easy to circumvent this. </1: 6.2, 7.5.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<2: 7.4.1, 7.5.3>It would need to be "behind the counter" in pharmacies, and pharmacists would need to regulate. However, even this seems like it would be easy to circumvent if something is a prescription item just for certain subpopulations.</2: 7.4.1, 7.5.3> <3: 7.4.6>For any subpopulation that is a minor, I would think a signature of a legal guardian would be necessary. </3: 7.4.6>

GENERAL

<4: 2.1>I would hope the FDA would never sacrifice safety for convenience. It seems like there is quite a push for convenience over safety, and my hope is that the FDA won't cave to the pressure. </4: 2.1>

COMMENT NUMBER - 2005N-0345-EC527

2005N-0345-EC527 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ramirez, Robert

2005N-0345-EC527 - TEXT

<1: 3.1, 3.8.3>Yes, if clarification is needed iniate a rulemaking interpretation. If a active ingredient scientifically shows that is safe and effective for the public and the only reason for the product not being available for the public is red-tape, then policy has to be amended.</1: 3.1, 3.8.3>

<2: 3.3.2>If an active ingredient is proven scientifically that it is safe for public use in the same dosage there should not be any difference. Make the product OTC. If needed for clarification codify the ingredients and list them for dual markets.</2: 3.3.2>

<3: 6.2>No. One this would be a enforcement nightmare. </3: 6.2><4: 1.2>Codify the active ingredients or have a resubmittal of the application and have physical developement and size as the criteria for dosage for effectiveness.</4: 1.2>

GENERAL

<5: 1.2>Fundamental there is an age limit on the initial inital application. Does the scientific evidence show significant differences with regards to age? This should be the question. If not have the application resubmitted without age and included individual physical development and size. </5: 1.2>

COMMENT NUMBER - 2005N-0345-EC53

2005N-0345-EC53 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: McGhee, Tim

2005N-0345-EC53 - TEXT

Issue Areas/Comments

It's very unclear to me how OTC status would not render completely irrelevant a drug's prescription status--especially when it's the same drug.

<1: 4.3.4>It's very unclear to me how OTC status would not render completely irrelevant a drug's prescription status--especially when it's the same drug.</1: 4.3.4>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1>Yes, the FDA's interpretation would create legal confusion.</2: 4.1> <3: 7.5.3>That said, young people today are bright and would quickly figure out a way around the system/confusion. We don't need a second-tier market of these pills between younger and older teenagers.</3: 7.5.3>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.2>I find this to be unlikely.</4: 5.2>

<5: 7.5.3>As I mentioned in response to 1B, there would be no limitation. The FDA is trying to parse out a particular subpopulation into segments which are inherently fluid--teenage girls. Saying 15-year-olds need a prescription, and 16-year-olds don't?

The FDA may find it needs to draw an imaginary line dividing the two, but that line would not extend very far beyond the confines of the FDA into reality.</5: 7.5.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.2>I do not believe it could.</6: 7.2>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.9>The package doesn't change the contents, but it might change who is more likely to obtain the drug.

The tobacco industry was blasted for using "Joe Camel" that attracted young people to smoking. The moral of the story here is, changing the packaging would only increase who is likely to get the drug, not limit young people from getting the drug.</7: 8.9>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<8: 9.2.1>Let's say the drug maker gets a green like to market the hell out of this drug--specifically for the 16-year-old girls and up market.

Continuing with the Joe Camel analogy, if they market the drug in areas to reach girls significantly under the specified age (such as 13, 14, 15), then the packaging in the marketing should match the prescription packaging, not the OTC packaging.</8: 9.2.1>

GENERAL

<9: 1.2.4>I don't believe this drug should be on the market at all.

As we have discussed in the cloning and embryonic stem cells debates, the union of egg and sperm is the beginning of life. I began there; we all began there.

This drug specifically thwarts the ability of that newly formed life from becoming the person God created them to be. This drug prevents the essential implantation of that life into the woman's body. That's killing it.

The use of this drug is wrong, and should not be endorsed by the FDA. </9: 1.2.4>

Thank you for your time, and for allowing me to speak.

Tim

COMMENT NUMBER - 2005N-0345-EC535

2005N-0345-EC535 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rectenwald, Theodore

2005N-0345-EC535 - TEXT

Issue Areas/Comments

<1: 3.1>Yes.</1: 3.1> <2: 3.8.1>Clarity is necessary.</2: 3.8.1>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.2>No.</3: 4.2>

<4: 6.1>Yes.</4: 6.1> <5: 6.6.3>This is already done, for instance, with tobacco and alcohol.</5: 6.6.3> <6: 1.2.3, 6.5.4>In the case of the abortifacient "morning-after-pill," direct OTC sales to minors without parental consent runs counter to every medical ethic currently practiced. Indeed, public health authorities will not even administer government-mandated immunizations without parental consent. To treat this matter differently would not only offer an absurd exception, but also engender a serious violation of parental rights and amount to an invansion of family privacy.</6: 1.2.3, 6.5.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

<7: 6.6.3, 7.1>Yes, in the same manner as sales of tobacco and alcohol are controlled.</7: 6.6.3, 7.1> <8: 1.2.3>On the other hand, kindly note that I am opposed to making this particular drug available in any but prescription form, if at all. It is dangerous and should not be available at all, let alone without a prescription.</8: 1.2.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<9: 9.3>On the (false) assumption that it should be legal, the packaging would be irrelevant.</9: 9.3> <10: 8.2, 8.5.4>However, differences in packaging would make control of violations (sales to minors, for instance) easier to detect and, perhaps, prosecute.</10: 8.2, 8.5.4>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

Same as above.

GENERAL

<11: 1.2.3>I am vehemently opposed to the availability of this abortifacient in general but, in view of the FDA's acceptance of it, would at least like to ensure that it continues to be accessible only by prescription. If this dangerous drug is foolhardily to be made available OTC, at a minimum access for minors ought to be restricted by the need for a prescription. </11: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC54

2005N-0345-EC54 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rommel, Scott

2005N-0345-EC54 - TEXT

Issue Areas/Comments

<1: 3.1, 3.8.1>Yes, this would seem to be a required point considering the amount of drug therapies available and the numders will only increase. In addition, when ever there are regulatory vagaries groups seems to always take advantage and promote unintended agendas.</1: 3.1, 3.8.1>

Yes, see above.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1>Yes.</2: 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.1>Yes.</3: 5.1>

<4: 3.8.7, 6.2>NO, This seems to be a problem waiting for a whole lot of money to be waisted on. Either a drug is over the counter or it is not.</4: 3.8.7, 6.2>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.2, 7.4.1, 7.4.4>Most likly not, the only practicle level of screening that may work is to have a drug OTC, but behind the counter where an ID is the only questioning limiting the drugs despensing.</5: 7.2, 7.4.1, 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.2, 8.6.4>This would seem to be a problem waiting to happen. If this is to occur then the two packages should be different. It does not seem reasonable to require a possible enforcement protocol to account for an item with the same packaging with one being legal OTC and the other not.</6: 8.2, 8.6.4> <7: 3.8.7>Either trust the majority of the population to do right and keep it all OTC or distrust and try to manage the minority and keep products behind a counter under strict control, both will have good and bad social consequences but one will cost more.</7: 3.8.7>

COMMENT NUMBER - 2005N-0345-EC555

2005N-0345-EC555 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Della Paolera, Mark

2005N-0345-EC555 - TEXT

Issue Areas/Comments

No.

<1: 3.2>No.</1: 3.2>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2>No.</2: 4.2>

<3: 6.2>NO, the FDA cannot guarantee that such age restrictions would be satisfied.</3: 6.2> <4: 7.5.3>Underage patients would still have access to the drug whether it is other persons of age purchasing it for them, theft, or cashiers selling it without certifying a person's age.</4: 7.5.3> <5: 1.2.3>Plan B needs to remain behind the counter.</5: 1.2.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.2, 8.6.4>NO, confusion could occur with stocking issues. When a shipment of Plan B arrives, is it stocked in the front end of the store or in the pharmacy? Separate packaging is necessary.</6: 8.2, 8.6.4>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 7.4.1, 9.2.2>There is none. It needs to remain behind the counter.</7: 7.4.1, 9.2.2>

GENERAL

<8: 1.2.3>The marketing and selling of Plan B as an OTC product is a terrible idea. The general population need to have a greater understanding of the drug and granting it an OTC status revokes the importance of its use, how it is used, and how it acts to the consumer. There needs to remain a patient- healthcare professional relationship. Often when a product is granted OTC status, the public's perception is that the intervention of a healthcare provider is not necessary. Placing Plan B OTC prevents important aspects that need to be addressed to the patient. One such example is notifying patients of its mechanism of action. Many do not know that it prevents a fertilized egg from adhering to the endometrium and often choose to not perform this method of 'contraception' as they would view this as an abortion. Patients also need to be informed on potential side effects and need to guarantee that the patient is using it within 72 hours. When a product goes OTC, many patients will use a product against the manufacturer's recommendation. Having a pharmacist involved can help prevent such complications. Furthermore, the phrase 'emergency contraception' is a misnomer to many patients who may believe this is an item that could be taking regularly prior to each act of coitus. i.e., the public needs to know that there are safer and more effective means of contraception than purchasing Plan B.</8: 1.2.3> <9: 7.5.3>One final aspect to consider is that no one could guarantee that children under 16 would not have access to the drug. Cashiers could unknowing sell it to an underage person, it could be stolen, and it could be purchased by a person of age and given to the underage child.</9: 7.5.3> <10: 1.2.3>In summary, Plan B needs to remain behind the counter to protect the safety of patients by maintaining a patient-provider relationship.</10: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC56

2005N-0345-EC56 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Porter, Rebecca

2005N-0345-EC56 - TEXT

Issue Areas/Comments

<1: 3.2>No.</1: 3.2><2: 3.8.8> If the medication is not safe enough for OTC use then it should be sold only by prescription to maintain the safety for all parties. Making it OTC will make it available to the group for whom it is not acceptably safe.</2: 3.8.8> <3: 3.3.3, 7.5.3>There is too great a potential for this drug to be abused. There is more to this issue than carding the patient. Fake ids are easily found. Who will monitor these patients that are taking the prescription? Medications that are taken OTC are expected to be safe and not need a doctor's follow up.</3: 3.3.3, 7.5.3>

No. There is too great of a potential for this drug to be abused and lives to be put into danger. <4: 1.2.3>The use of this medication should be monitored by a responsible physician only.</4: 1.2.3>

<5: 6.2>No.</5: 6.2> <6: 6.6.3, 7.5.3>Look at the amount of alcohol that is sold to minors. There will always be a way for the underaged to get this medications.</6: 6.6.3, 7.5.3>

COMMENT NUMBER - 2005N-0345-EC566

2005N-0345-EC566 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Burgess, Annette

2005N-0345-EC566 - TEXT

Issue Areas/Comments

No.

<1: 3.2>No.</1: 3.2>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2>No.</2: 4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.2>No.</3: 5.2> <4: 1.2.3>There is a secondary danger of allowing this drug to go into an over-the-counter class. If this pill were allowed to become an over-the- counter medication, it could deny a woman the safety of conversing with her doctor the medical risks of taking it, deny the woman the privacy of deciding if she wanted to take the prescription or not, and might allow the woman's mate to buy the drug and coerce her to take it against her wishes, her health or that of her unborn child. To change this interpretation would not allow a woman to have a witness (i.e., the doctor who would writes the prescription) that she indeed did ask for this drug. Changing this drug's designation to Over-the-counter, would not give the woman the privacy to make her own choice in whether this drug was too dangerous to her health or not.</4: 1.2.3> <5: 6.5.4>To change the interpretation might bring legal consequences upon the FDA or the stores selling this drug if a wrongful death suit were initiated.</5: 6.5.4>

<6: 6.2>No.</6: 6.2> <7: 6.5.4>What would be legal consequences in a wrongful death suit to the FDA and the stores who carry this OTC medication?</7: 6.5.4> <8: 3.8.7>A subpopulation ruling would open a pandora's box to all kinds of hybrid requests that would tie up government as well as be a financial burden on stores which carried such products as they'd have to hire additional employees, etc. in an already stressful environment to provide timely prescriptions. Talk about back-log!</8: 3.8.7>

B. If it could, would it be able to do so as practical matter and, if so, how?

<9: 7.2>It couldn't.</9: 7.2> This would open the door to all kinds of age-related or hybrid

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<10: 8.2, 8.6.4>No, because of the harmful side effects of this drug.</10: 8.2, 8.6.4>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<11: 8.2>It should not be legal.</11: 8.2>

GENERAL

There is a secondary danger of allowing this drug to go into an over-the-counter class. If this pill were allowed to become an over-the-counter medication, it could deny a woman the safety of conversing with her doctor the medical risks of taking it, deny the woman the privacy of deciding if she wanted to take the prescription or not, and might allow the woman's mate to buy the drug and coerce her to take it against her wishes, her health or that of her unborn child. To change this interpretation would not allow a woman to have a witness (i.e., the doctor who would writes the prescription) that she indeed did ask for this drug. Changing this drug's designation to Over-the-counter, would not give the woman the privacy to make her own choice in whether this drug was too dangerous to her health or not. To change the interpretation might bring legal consequences upon the FDA or the stores selling this drug if a wrongful death suit were initiated.

No. What would be legal consequences in a wrongful death suit to the FDA and the stores who carry this OTC medication? A subpopulation ruling would open a pandora's box to all kinds of hybrid requests that would tie up government as well as be a financial burden on stores which carried such products as they'd have to hire additional employees, etc. in an already stressful environment to provide timely prescriptions. Talk about back-log!

COMMENT NUMBER - 2005N-0345-EC569

2005N-0345-EC569 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Tansley, Kathleen

2005N-0345-EC569 - TEXT

Issue Areas/Comments

<1: 3.2>I feel strongly that the FDA should not initiate a rulemaking to codify their interpretation of section 503(b), about duel-marketing both a prescription drug product and simultaneously an OTC product. </1: 3.2>

<2: 1.2.3>Making Plan B over the counter would create numerous problems especially with regard to keeping it out of the hands of minors.</2: 1.2.3> <3: 7.5.2, 7.5.3>The FDA has no mechanism for enforcing a regulation that prohibits sale to minors. And enforcing this could not only cause serious controversy on both sides of the spectrum, but be very difficult to regulate.

I feel the FDA should step back and realize this, and not go further with this type of policy change.</3: 7.5.2, 7.5.3>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<4: 4.2>I myself, am not confused by 503(b) as explained on your web site here.</4: 4.2> <5: 3.8.8>But I have written my serious concerns above (see A), and see no logical reason for the FDA to change their policy on this issue, it would create serious controversay, difficulty, and perhaps even future lawsuits from consumers at the extreme.</5: 3.8.8>

C. If so, would a rulemaking on this issue help dispet that confusion?

<6: 3.2, 3.8.8>I believe the rulemaking should stay as it is. And not go change policy, allowing duel-marketing of both a prescription drug product and simultaneously an OTC product. The FDA should remain firm on this issue in this regard.</6: 3.2, 3.8.8>

<7: 6.2, 6.5.4, 7.5.3>Selective limitation of a product to a sub-population could bring on lawsuits from either end of the spectrum from disgruntled consumers, as well as media controversy on the issue, and a near insurmountable impossibilty to enforce such a regulation.

This is a bad idea for the FDA to pursue.</7: 6.2, 6.5.4, 7.5.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<8: 7.2>No. I cannot see this happening.</8: 7.2>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<9: 3.8.5>This again would be a cause for concern for the consumers, and controversy could arise, and laws must be changed, and I feel this is incorrect to do a 'blanket change of policy for reinforcement on duel-marketing drugs' in this manner.

What if other drugs arise in the future and likewise the drug companies suppling the consumers would want the same option, and what if there is cause for concern that this would be detrimental to the consumers by doing this? The FDA would then have to do 'damage control' and back-pedal on their policy on rulemaking if they follow this route. </9: 3.8.5>

COMMENT NUMBER - 2005N-0345-EC572

2005N-0345-EC572 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Naughton, John

2005N-0345-EC572 - TEXT

Issue Areas/Comments

<1: 1.2.3>Why approve OTC use of a drug which is generally ineffective?

Morning-after pill access fails to cut pregnancy rate - January 5, 2005 </1: 1.2.3>

By Cheryl Wetzstein
THE WASHINGTON TIMES

<2: 1.2.3>Women's health care advocates have been urging the federal government to allow easy access to "morning-after" pills as a way to dramatically reduce unintended pregnancies. However, a study released today undercuts that argument by showing that young sexually active women who were handed packages of "morning- after" pills had pregnancy rates six months later that were virtually the same as women who had to go to drugstores or clinics to get the pills. "That was definitely a disappointing finding," said Tina R. Raine, lead researcher of the study of 2,117 women, which appears in today's Journal of the American Medical Association (JAMA). A core hypothesis, she said, was that two groups of women with easy access to "emergency contraception" (EC) would have half as many pregnancies as women who had to see a health provider to get the pills. Instead, all three groups of women had pregnancy rates of around 8 percent. Nevertheless, EC should still be available without a prescription, said Dr. Raine, a professor at the University of California at San Francisco. That's because the study also showed that when women had easy access to EC, they used the pills more often, but they didn't take more sexual risks or get more sexually transmitted diseases (STDs), as some have feared. Given these findings, "it seems unreasonable to restrict access to EC to clinics," Dr. Raine and her colleagues wrote. Concerned Women for America analyst Wendy Wright, an opponent of EC, disagreed. "Why make [EC] easily available and put women's health at risk if it doesn't even reduce what the women fear, which is pregnancy?" she said. Emergency contraception refers to high-dose birth-control pills taken within 72 hours of unprotected sexual intercourse. The pills, used by 4 percent of women, can interrupt ovulation, fertilization or implantation. All but six states require a prescription to get EC. Most women's health advocates believe that half of the nation's estimated 3.5 million unintended pregnancies could be prevented if EC were widely available, especially to teens and college-age women. They believe the pills are safe and effective, and they have launched campaigns urging the federal Food and Drug Administration (FDA) to allow the nation's primary EC product, Plan B, owned by Barr Pharmaceuticals Inc., to be sold without a prescription. Opponents of EC, such as Miss Wright, worry that easy access to EC will encourage irresponsible sexual behavior and STDs.

Studies of EC in Britain show easy access to the pills causes "an increase in STDs and no decrease in the number of abortions," she said. In 2003, two FDA advisory panels recommended that the FDA approve Plan B for over-the-counter sales, but in May, the FDA declined, saying it was concerned about teens using the product without medical supervision. A spokeswoman for Barr Pharmaceuticals yesterday said they have resubmitted Plan B paperwork and are expecting another FDA response this month. The Raine study, conducted between 2001 and 2003, divided 2,117 sexually active women, aged 15 to 24, into three groups. One group received free packages of Plan B, another group was told how to get Plan B for free at drugstores and a third group was told how to get Plan B by appointment from a health clinic. A key hypothesis was that, six months later, women in the two groups with the easiest access to EC would have 5 percent pregnancy rates, compared with a 10 percent pregnancy rate expected for women who had to go to a clinic to get Plan B. But the three groups still got pregnant at about the same rate: Eight percent of the women with Plan B at home became pregnant, as did 7.1 percent of women with "pharmacy access" and 8.7 percent of women with "clinic access."</2: 1.2.3>

<3: 1.2.3>Why approve OTC use of a drug which increases the risk to women's health - abortion?

Nonprescription EC Linked to Rise, Not Drop, in Abortion Rates --Yet Advocates Continue to Push for Over-the-Counter Sales

Newly published figures on the number of abortions taking place in Britain show that the abortion rate has increased despite the availability of so- called "emergency contraception" (or, as critics call it, the "morning after abortion pill") which can be purchased without a prescription. The abortion rate has increased each year since Britain introduced nonprescription EC in Jan. 2001, with 2.1 percent more abortions taking place in England and Wales in 2004 than in 2003. EC is a high dose of contraceptive hormones that can act as an abortifacient if the woman has already conceived. U.S. abortion advocates have claimed that it will reduce the abortion rate by half. However, studies in Scotland and the U.S. (including a study of more than 2,000 young women that was published in the Journal of the American Medical Association this past January) have shown that selling EC over the counter has not reduced pregnancy and abortion rates, even when women are given the drugs in advance and are therefore more likely to use it. In addition, the teen pregnancy rate increased 31 percent in Sweden after nonprescription EC became available there. While abortion advocates have claimed that the rise in abortion rates in Britain is due to other factors, critics say EC leads people to engage in more risky sexual behavior because they falsely think they are protected from pregnancy, leading to higher rates of unintended pregnancies, abortions, and sexually transmitted diseases. In addition, EC does not abort ectopic pregnancies and therefore women who use it may not realize they are still pregnant, putting their health and lives at risk.

The new figures come as the Food and Drug Administration announced it is delaying a decision on whether it will allow nonprescription EC sales in the U.S, citing a lack of data on the drugs' effect on teens and an inability to enforce regulations limiting nonprescription sales to women over the age of 17. Seven states currently allow nonprescription EC sales. Barr Laboratories, which markets EC under the name "Plan B" says it is planning to urge other states to allow the sales. The Planned Parenthood Federation of America has also said it will file a lawsuit against the FDA if over-the- counter EC sales are not approved. According to memos released as part of a lawsuit filed against Planned Parenthood in California, the organization stands to make considerable profit from over-the-counter sales of EC because of a deal the group struck with Barr allowing them to purchase the EC kits at a price below that of other retailers. Planned Parenthood's price on the EC kits averages below that of the competition, and Planned Parenthood watchdog group STOPP, the organization could make $100 million or more in profits over the next five years if EC was made available over the counter.</3: 1.2.3>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

No comment

C. If so, would a rulemaking on this issue help dispet that confusion?

No comment

No comment.

B. If it could, would it be able to do so as practical matter and, if so, how?

<4: 7.2>Absolutely not.</4: 7.2> <5: 7.5.3>Older teens will buy the pills for younger teens.</5: 7.5.3>

COMMENT NUMBER - 2005N-0345-EC58

2005N-0345-EC58 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Venturella, Vincent

2005N-0345-EC58 - TEXT

Issue Areas/Comments

<1: 3.2>No. </1: 3.2><2: 3.8.4>There is no need to initiate any further rulemaking for codification of the action. It is quite clear in its present form.</2: 3.8.4>

No I believe the FDA's interpretation of the formal act for distinguishing the 2 parts of the isssue needs no further clarification,

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.2>There is no confusion as I read Commissioner Crawford's thinking on the manner that the decision and/or interpretation that needs to be encompassed.</3: 4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

N/A

<4: 6.1, 6.3.2>I do not see any deviation from the law(s) available to the FDA under the current FD&C Act that would prevent it from instituting this policy.</4: 6.1, 6.3.2>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.4.6, 7.5.3>As a practical matter, I do not envision an easy way to do this specifically for Plan B. It might be possible if the OTC portion was transacted in the manner that some exempt narcotics were handled in the periods prior to the 80s, when simple ledgers were kept for limited portions of the sale of exempts during a narrow window of time. However, as was obvious then, the signer was not always the subject end user and there was no proof that the dispensing act was aimed at the correct age group or ultimate patient.</5: 7