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FDA | FDA Centennial
Issues 3 – 9 (Responses to ANPRM Questions)
May 19, 2006
Final
Prepared by
ICF International
Fairfax, VA
3.1 - Yes
3.2 - No
3.3 - FD&C Act and amendments
3.3.1 - FD&C Act requires rulemaking.
3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
3.3.3 - Other arguments related to FD&C Act
3.4 - Administrative Procedures Act (APA) arguments
3.5 - Supplemental New Drug Application (SNDA) and New Drug Application (NDA) regulations
3.5.1 - SNDA/NDA regulatory arguments supporting rulemaking
3.5.2 - SNDA/NDA regulatory arguments opposing rulemaking
3.6 - Court opinion legal arguments
3.6.1 - Court case arguments supporting a rulemaking
3.6.2 - Court case arguments opposing a rulemaking
3.7 - Other legal arguments
3.7.1 - Other legal arguments supporting rulemaking
3.7.2 - Other legal arguments opposing rulemaking
3.8 - Policy arguments
3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
3.8.3 - Other policy arguments for initiating a rulemaking
3.8.4 - Interpretation is clear in present form
3.8.5 - Circumstances for OTC safety are case-specific
3.8.6 - Develop/update guidance as alternative for rulemaking
3.8.7 - Cost-benefit concerns regarding rulemaking
3.8.8 - Other policy arguments opposing a rulemaking
3.9 - Examples of previous FDA actions in allowing simultaneous marketing of Rx and OTC products
3.9.1 - Drug approval examples
3.9.2 - FDA guidance or other documents (e.g., FDA 1999 Manual of Policy and Procedures (MAPP) statements, testimony, letters to industry, Q&As)
3.9.3 - Veterinary drug policy
3.9.4 - Other examples
3.10 - Examples of FDA actions disallowing simultaneous marketing
3.11 - Miscellaneous arguments/discussions
4 - Is there significant confusion regarding interpretation of section 503(b) of the act? [ANPRM Q 1.B.]
4.1 - Yes
4.2 - No
4.3 - Arguments supporting significant confusion regarding FDA's interpretation
4.3.1 - FDA's interpretation of FD&C Act 505(b)(2) conflicts with interpretation of 503(b)
4.3.2 - Diverse industry and public opinion/reaction to ANPRM and statements re: FDA's authority
4.3.3 - Other legal arguments/conclusions supporting confusion re: FDA's interpretation
4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
4.4 - Arguments indicating that little or no confusion exists
4.4.1 - Legal arguments that little or no confusion exists
4.4.2 - Policy arguments that little or no confusion exists
4.5 - Miscellaneous arguments/discussions
5 - Would rulemaking for clarification dispel confusion? [ANPRM Q 1.C.]
5.1 - Yes
5.2 - No
5.3 - Arguments that support concept that a rulemaking would provide clarification
5.3.1 - Legal arguments supporting rulemaking to dispel confusion
5.3.2 - Policy arguments supporting rulemaking to dispel confusion
5.4 - Arguments that a rulemaking would not provide clarification
5.4.1 - Legal arguments that rulemaking would not clarify
5.4.2 - Policy arguments that rulemaking would not clarify
5.4.2.1 - Guidance instead of rulemaking
5.4.2.2 - Other policy arguments
5.4.3 - There is no confusion, therefore rulemaking unnecessary
5.5 - Miscellaneous arguments/discussions
6 - If FDA limited sale of OTC product to sub-population, would FDA be able to enforce limitation as a matter of law? [ANPRM Q 2.A.]
6.1 - Yes
6.2 - No
6.3 - Legal/policy arguments that support/detail FDA's authority to enforce limitation on availability of OTC products by sub-population
6.3.1 - FD&C Act
6.3.2 - No laws prevent the policy
6.3.3 - Court cases
6.3.4 - Age limitations are in line with other meaningful differences
6.3.5 - Other legal/policy arguments
6.4 - Examples/precedents that support/detail FDA's authority to enforce limitation on availability of OTC products by sub-population
6.4.1 - Nicotine replacement therapy (e.g., Nicorette)
6.4.2 - Other examples
6.5 - Legal/policy arguments that FDA does not have authority to enforce the limitation (or permit dual marketing or implement "behind-the-counter" (pharmacist distribution) system)
6.5.1 - FDA's authority limited to drug safety, effectiveness/efficacy, and labeling
6.5.2 - Other FD&C Act arguments
6.5.3 - Court cases
6.5.4 - Other arguments
6.6 - Authority of other entities to enforce the limitation
6.6.1 - State and local agencies have authority to enforce point-of-sale (e.g., recent limitations on cold medicines)
6.6.2 - Congress
6.6.3 - Alcohol and tobacco enforcement
6.6.4 - Other entities
6.7 - Miscellaneous arguments/discussions
7 - Would FDA be able to enforce limitation to sub-population as a practical matter? [ANPRM Q 2.B.]
7.1 - Yes
7.2 - No
7.3 - Actions FDA could take in order to enforce limitation of an OTC product to a sub-population
7.3.1 - Regulate product sponsor
7.3.1.1 - Require sales restrictions as condition for approval (e.g., restrict sales to entities that are licensed pharmacies)
7.3.1.2 - Require retailer, pharmacist, and consumer education programs
7.3.1.3 - Require risk management program...
7.3.1.4 - Other product approval conditions
7.3.2 - Other FDA enforcement practices that it has the legal authority to put in place
7.4 - Other point-of-sale enforcement suggestions
7.4.1 - Implement "behind-the-counter" system (pharmacist distributed)
7.4.2 - Involve other authorities (e.g., states, state boards of pharmacies)
7.4.3 - Monitor compliance and enforcement / conduct random inspections
7.4.4 - Require identification for age
7.4.5 - Pursue criminal actions against violators
7.4.6 - Other actions
7.5 - FDA will be unable or it will be difficult to enforce as a practical matter
7.5.1 - FDA does not have authority to enforce limitation, and it cannot enforce as a practical matter
7.5.2 - Infrastructure for FDA enforcement (e.g., resources, personnel, training, monitoring, third-party regulations) not in place
7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
7.5.4 - Other arguments
7.6 - Miscellaneous arguments/discussions
8 - Assuming legal to market both, may the prescription (Rx) and OTC products be legally sold in the same package? [ANPRM Q 3.A.]
8.1 - Yes
8.2 - No
8.3 - Legal arguments supporting one package label for Rx and OTC sales
8.3.1 - FD&C Act arguments (e.g., single label could be created that satisfies both sets of statutory requirements)
8.3.2 - Do not need separate National Drug Code (NDC) numbers
8.3.3 - Court cases
8.3.4 - Other legal arguments supporting one package label
8.4 - Policy arguments supporting one package label for Rx and OTC sales
8.4.1 - Other policy arguments supporting one package label
8.5 - Legal arguments opposing one package for Rx and OTC sales
8.5.1 - FD&C Act - Legal differences between statutory requirements for Rx and OTC
8.5.2 - Court cases arguments opposing one package
8.5.3 - Need separate National Drug Code (NDC) numbers for billing
8.5.4 - Other legal arguments opposing one package
8.6 - Policy arguments opposing one package for Rx and OTC sales
8.6.1 - Single package contrary to meaningful difference standard
8.6.2 - Risk of medication errors or threats to patient safety
8.6.3 - Same packaging permits/encourages trading/swapping
8.6.4 - Other arguments opposing one package
8.7 - Examples of Rx and OTC labeling that is similar but with one or two differences - e.g., dosage/age distinction
8.8 - Examples of similar labeling of Rx and OTC products that are the same drug and dose, in the market place or previously marketed
8.9 - Miscellaneous arguments/discussions
9 - If they can be legally sold in same package, under what circumstances would it be inappropriate to do so? [ANPRM Q 3.B.]
9.1 - Circumstances in which it is inappropriate to distribute products in a single package
9.1.1 - Specific circumstances
9.1.2 - All circumstances (i.e., it's always inappropriate)
9.2 - Circumstance in which it is appropriate to distribute in single package
9.2.1 - Specific circumstances
9.2.2 - All circumstances (i.e., it's always appropriate, there are no inappropriate circumstances)
9.3 - Miscellaneous arguments/discussions
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 24
Excerpt Status: NEW
Excerpt Text:
III. FDA Must Initiate And Complete Full Rulemaking Proceedings In Order To Institute The Simultaneous Dual Marketing Of The Same Rx/OTC Drug Product
FDA has asked whether it should proceed with notice and comment rulemaking to codify the FDA's interpretation of Section 503(b) as to when a drug can be dually marketed as OTC and by prescription, since FDA historically has not allowed marketing of the same active ingredient in a prescription for one population and OTC for another. The brief answer is yes.
Commenter Organization Name: White, Molly
Comment Number: 2005N-0345-EC107
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
Sure. Rules are great. Everyone knows the game plan when regulations exist, provided they are short, clear and to the point.
Commenter Organization Name: Burometto Jr, Charles
Comment Number: 2005N-0345-EC109
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Black, Jerrold
Comment Number: 2005N-0345-EC111
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Mershon, Claire-Helene
Comment Number: 2005N-0345-EC12379
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
Yes. Plan B should be available OTC, and while I disagree that it should be split between OTC and prescription, I understand the concerns of the FDA in taking the action for women under 16. However, this should not keep the FDA from keeping it off of the shelves completely. If an active ingredient is judged to be safe for use OTC by women, it should be sold that way. If it is necessary to make the drug prescription for one population in order for that to happen, then the FDA should review its rules and allow the drug to be available in both forms.
Commenter Organization Name: Dougherty, Anne
Comment Number: 2005N-0345-EC126
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Chihane, Ziad
Comment Number: 2005N-0345-EC13197
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
NEW - 5.1 - Yes
Excerpt Text:
The rulemaking in question is of utmost importance in regards to health and safety of citizen of the United States. The FDA should absolutely initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product. The act in itself is unclear and with the high degree of importance that medicine serves to citizens it is imperative that there be rulemaking in regards to this issue. The confusion that occurs with the FDA's interpretation of section 503(b) is that they have set limits in the amount of dosage that something can have depending if it is OTC or a prescription drug. But this is not very clear this is why I believe that FDA should go into a more effective rulemaking process to better regulate this issue. The way that the rule is currently setup I believe leaves a lot of room for speculation, which is not something that needs to be done with prescription or OTC drugs. If we don't put a more effective rule on the section 503(b) it could eventually get out of control. So yes I do believe that rulemaking on this issue would dispel the confusion that is along with this section 503(b).
Commenter Organization Name: Rahl, Michael
Comment Number: 2005N-0345-EC13845
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
There is sufficient reason for the FDA to initiate a rulemaking to codify its interpretation of Section 503(b) as to when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product because the lack of legislation has created interpretations that have had some success but whose scope is not broad enough to address concerns that arise outside of their margins that focus primarily on the safety to the consumer. In the absence of such codification we find misspent FDA resources, delay on the marketing of certain drugs, a consequent profit loss by pharmacies and pharmaceutical companies, and specific needs of members of our society have been put on hold while the FDA balks in this decision making process. In codifying the aforementioned interpretation of section 503(b), the FDA could maximize its procedural efficiency and increase its service level output to the nation which would generate broader levels of satisfaction to society's needs.
Commenter Organization Name: Nguyen, Marie
Comment Number: 2005N-0345-EC13851
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Addressed in this comment are the reasons why I believe there should be an imitative in rulemaking and following are the comments on certain concerns.
Commenter Organization Name: Connors, Meaghan
Comment Number: 2005N-0345-EC141
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes. Doing so would move this prolonged, highly politicized process.
Commenter Organization Name: Soriano, Lauren
Comment Number: 2005N-0345-EC14388
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
The Food and Drug Administration should initiate rulemaking in order to see if an active ingredient can be simultaneously marketed in both a prescription and over-the-counter drug. However, there has to be stipulations on the over-the-counter drug because if the same active ingredient is in both the prescription product and the over-the-counter product, then what would be the purpose of a prescription drug. People would just flock to the OTC drug, since it is so accessible.
Commenter Organization Name: Steele, Robert
Comment Number: 2005N-0345-EC146
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
Excerpt Text:
If 503(b) does not allow for the simultaneous marketing of a drug based on age or other factors, it should be amended. Precedences exist for such substances such as alcohol and tobacco products to be marketed based on age. The purchase of other non-ingestible items are certainly marketed by age, mental competency, criminal convictions, etc.. This is not a difficult and/or complexed procedure.
Commenter Organization Name: Steele, Robert
Comment Number: 2005N-0345-EC146
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
This too is not a difficult or complexed task. If an amendmentis - based on changing circumstances warrants - obvious and needed, than the change(s) should made based on procedural issues and not politics or ideological leanings.
Commenter Organization Name: Loomis, Shirley
Comment Number: 2005N-0345-EC147
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, provided the drug is safe for distribution.
Commenter Organization Name: Marshall, Laura
Comment Number: 2005N-0345-EC15
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
Codifying an interpretation can only help--make it clear exactly why and when a drug is being marketed OTC and Rx at the same time, and make it clear that the reasons are not political but medical.
Commenter Organization Name: Lamotte, Diane
Comment Number: 2005N-0345-EC155
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, I believe a rulemaking is in order.
Commenter Organization Name: Association of American Physicians & Surgeons
Comment Number: 2005N-0345-EC15690
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.4 - Administrative Procedures Act (APA) arguments
Excerpt Text:
The FDA should not render a decision affecting millions of Americans without allowing full notice and comment by physicians and patients, pursuant to a formal rulemaking proceeding. The Administrative Procedures Act (APA) requires notice and comment prior to promulgation of a new rule, and there is no valid reason to deny public input on the important issue of marketing an active ingredient as both a prescription drug and over-the-counter (OTC) drug. AAPS objects to any attempt by the FDA to bypass notice and comment procedures in connection with Section 503(b) of the Federal Food, Drug, and Cosmetic Act (FDCA), as modified by the Durham-Humphrey Amendments, which governs the classification of drugs.
Commenter Organization Name: Association of American Physicians & Surgeons
Comment Number: 2005N-0345-EC15690
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 3.4 - Administrative Procedures Act (APA) arguments
Excerpt Text:
In sum, AAPS objects to any assertion in authority by the FDA to make age-based classifications for prescription and OTC sales of drugs. If the FDA is seeking such authority, then at a minimum it needs to comply with formal rulemaking and address the objections raised by physicians and patients alike.
Commenter Organization Name: Walsh, Melissa
Comment Number: 2005N-0345-EC15931
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 4.2 - No
NEW - 4.4.1 - Legal arguments that little or no confusion exists
Excerpt Text:
B. The FDA's interpretation is an accurate interpretation of the law. It is also scientific, because this policy is in keeping with the known fact of chemistry that to decrease the toxicity of a product its concentration must be in some way decreased. Thus it must follow in medicine, if a drug is to be safe it must be marketed at non-injurious levels. If it is sold at higher concentrations it should be under the supervision of a physician. Consequently there should be no confusion to the FDA's policy as it is both scientific and in keeping with the intent of the law. In order to avoid future challenges by drug companies and pharmacies to the FDA's interpretation of 503(b) of the act, the FDA's unwritten interpretation should be codified as law.
Commenter Organization Name: Smart, Stephanie
Comment Number: 2005N-0345-EC16
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
Excerpt Text:
A drug is not only its active ingrediant. It is a combination and has different uses based on the combination or the dosage. So yes, I think that a drug should be available by prescription and OTC containing the same active ingrediant.
Commenter Organization Name: Hutson, Paul
Comment Number: 2005N-0345-EC162
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
Excerpt Text:
The FDA should allow for the dispensing of selected drugs without a prescription by a licensed pharmacist, physician's assistant, or nurse practitioner.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes, APhA would support efforts by the FDA to codify the Agency's interpretation of Section 503(b), the Federal standard used to classify drug products as prescription or OTC.
Commenter Organization Name: Subcommittee on Criminal Justice, Drug Policy
Comment Number: 2005N-0345-EC16770
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Subcommittee on Criminal Justice, Drug Policy
Comment Number: 2005N-0345-EC16770
Excerpt Number: 12
Excerpt Status: NEW
Excerpt Text:
For the foregoing reasons, we strongly suggest that FDA codify its current interpretation of §503(b)(1) of the Federal, Food, Drug and Cosmetic Act.
Commenter Organization Name: Wilson, Rhianna
Comment Number: 2005N-0345-EC186
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
Yes. There are already other laws and rules involved in the process of purchasing OTC medications. Such as only being allowed to purchase so many packages of sudafed etc. So inflicting another law on societies consumers will not come as a shock. Especcially dealing with a medication that carries so much of an importance to release because of its immeditate window of effectivness.
Commenter Organization Name: Moon, Kristin
Comment Number: 2005N-0345-EC1927
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Yes--often patients will abuse the OTC product--that is--to take it incorrectly and do themselves harm--even when the package is labeled for safe use. Other times, patients need doctor contact to rule out severe illnesses or needs, but having the medication available OTC keeps them out of the doctor's office
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Tuchinsky, Marla
Comment Number: 2005N-0345-EC201
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
To the extent that your interpretation is preventing women from getting access to a perfectly safe and effective drug, yes.
Commenter Organization Name: Oyen, Duane
Comment Number: 2005N-0345-EC2107
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Oyen, Duane
Comment Number: 2005N-0345-EC2107
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 2.1 - Comments on time, manner, and nature of rulemaking process
Excerpt Text:
Yes- and in a realistic way, not as outlawing disguised as regulation.
Commenter Organization Name: Ellis, Pamela
Comment Number: 2005N-0345-EC216
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
yes
Commenter Organization Name: Cunningham, Wayne
Comment Number: 2005N-0345-EC240
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
Yes, this is an issue that needs to be decided, and has certainly been resolved in areas concerning controlled substances. It's not all that new or novel.
Commenter Organization Name: Levinson, R. Saul
Comment Number: 2005N-0345-EC297
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.2 - Approve simultaneous marketing approach (market both OTC and Rx)
NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Yes, there are instances where a professional may prescribe a product when he has contact with a patient, and instances where a drug product may be needed without prescribing professional interaction. This is certainly the case with "Plan-B"... as it is an emergency contraceptive, the user could be in a situation where there is no time for contact with a prescribing professional (weekends, holidays, afterhours, etc.)... and needs immediate access to the drug.
Commenter Organization Name: Wu, Jackie
Comment Number: 2005N-0345-EC307
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Waychoff, W. Aaron
Comment Number: 2005N-0345-EC311
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
Yes - the FDA should understand that, just like many other substances in our society, factors beyond simply the direct effectiveness and safety of the product on the human body must be taken into account. Many medications currently available OTC effect persons of different ages differently and carry labeling indicating such. In this labeling, use outside what is indicated by young persons is deferred to a physician's recommendation. Similarly, drugs such a Plan B could be made available OTC and carry labeling indicating that its use for women under 16 (or 17) is restricted to a physician's recommendation - in the form of a prescription. Remember, a prescription is little more than an official recommendation by a physician to use a particular medication at a particular dose.
Commenter Organization Name: Collum, Mark
Comment Number: 2005N-0345-EC33
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
Excerpt Text:
Yes. This should either be fully OTC or it should be classified into a category where RPh can prescribe and dispense it.
Commenter Organization Name: McLeod, Doug
Comment Number: 2005N-0345-EC364
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes it should and the decision should be made to allow this action. Especially if the scientific evidence supports that decision.
Commenter Organization Name: Tufts, Gillian
Comment Number: 2005N-0345-EC399
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Kulshrestha, Vikram V
Comment Number: 2005N-0345-EC405
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Labbe, Carl
Comment Number: 2005N-0345-EC408
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
Excerpt Text:
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.
Commenter Organization Name: Thompson, Donald
Comment Number: 2005N-0345-EC416
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.3 - Maintain Rx only
NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
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
Commenter Organization Name: Duchon, Kathleen
Comment Number: 2005N-0345-EC426
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
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.
Commenter Organization Name: Duchon, Kathleen
Comment Number: 2005N-0345-EC426
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes, times are we a consumer can get a product in illegal ways. Why not make it a safe consumer choice?
Commenter Organization Name: Stier, Christopher
Comment Number: 2005N-0345-EC495
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Cunningham, Laura
Comment Number: 2005N-0345-EC5
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
YES
Commenter Organization Name: Zahn, Steven
Comment Number: 2005N-0345-EC52
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Ramirez, Robert
Comment Number: 2005N-0345-EC527
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
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.
Commenter Organization Name: Rectenwald, Theodore
Comment Number: 2005N-0345-EC535
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Rommel, Scott
Comment Number: 2005N-0345-EC54
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
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.
Commenter Organization Name: Leonard, Ruth Tehila
Comment Number: 2005N-0345-EC59
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I don't quite understand this question, but if you mean should you set a standard whether or not a product with the same active engredient can be sold on and off the counter simultaneously I think the answer is yes.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
If we assume that Plan B has not been shown to be safe without prescription for children under 17, then the new regulations should be considered. A drug that can be very helpful to women and is only denied based on ideaology instead of science should be made available by any truly scientific health organization.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I think that the FDA should make rules about when a drug can be sold as both prescription and OTC
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
I think that actually codifying this would be good.
Commenter Organization Name: DeWitte, Conrad
Comment Number: 2005N-0345-EC623
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Yes. It would inform the voting and pharmaceutical consuming public to understand how such decisions are analyzed and made, including the medical purpose for creating at once a controlled and an uncontrolled distribution channel for the same product.
Commenter Organization Name: Peer, Gerald
Comment Number: 2005N-0345-EC626
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
The FDA should clearly define its policy. Its previous position, that a substance cannot be both prescription and OTC for the same indication, is rational and defensible and should be codified.
Commenter Organization Name: Ray, Amy
Comment Number: 2005N-0345-EC65
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Kortebein, Peter
Comment Number: 2005N-0345-EC654
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, if the benefit is clearly defined to those who would benefit from such an interpretation.
Commenter Organization Name: Baird, Debora
Comment Number: 2005N-0345-EC66
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Ricci, Stephen
Comment Number: 2005N-0345-EC73
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Carlson, Brent
Comment Number: 2005N-0345-EC77
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Macdonell, Megan
Comment Number: 2005N-0345-EC779
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
There are many medications that have the same active ingredient available in both a generic/OTC method as well as through prescription. With that said I am also unaware of the guidelines by which these decisions are made, however I do not personally see it as a problem. I believe that there should be a "re-wording" of section 503(b).
Commenter Organization Name: Kuskey, Garvan
Comment Number: 2005N-0345-EC793
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.10 - Examples of FDA actions disallowing simultaneous marketing
Excerpt Text:
If 5% testosterone -- a completely benign substance -- must be written on a triplicate prescription, then why not this more dangerous preparation?Or the reverse: if this drug can be marketed without a prescription to those over sixteen years of age, then why can't 5% testosterone be marketed to elderly men who need HRT? The FDA designated low-dose testosterone a dangerous drug specifically because of its abuse by body builders. And yet, body builders don't use 5% preparations. In fact, they can and do easily buy much more concentrated products in Mexico.
Commenter Organization Name: Camron, Kiera
Comment Number: 2005N-0345-EC811
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Despite all of these risks, proponents are agitating (loudly) for these drugs to be made available over the counter, available without the advice of a medical professional who would provide vital education and assessment of a woman?s risk. The well-being of Americans is at stake; it is the FDA?s responsibility to ensure the involvement of medical professionals and prevent the over the counter sale of EC.
Planned Parenthood claims that EC will prevent 1.7 million unintended pregnancies and prevent 800,000 abortions each year in the United States, yet studies in the prominent medical journal The Journal of the American Medical Association and others in countries where EC has routinely been used for years show no change in pregnancy rates with over the counter availability of EC. So why the stubborn promotion of EC? What agenda could possibly justify the exploitation of American women?
I, for one, am thankful for the FDA taking the time to look more carefully at this dangerous drug. With any luck, they will conclude that over the counter EC is one ?blessing? America can do without.
Commenter Organization Name: Wagner, Patricia
Comment Number: 2005N-0345-EC813
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 8.6.2 - Risk of medication errors or threats to patient safety
Excerpt Text:
The FDA should issue an interpretation of section 503(b) that requires that when drugs are simultaneously marketed as both prescription and OTC their packaging and advertising must be so dissimular that the ordinary customer will identify them as two different products.
Commenter Organization Name: O'Hagan, James
Comment Number: 2005N-0345-EC827
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes it should.
Commenter Organization Name: Oyola, Sandra
Comment Number: 2005N-0345-EC85
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
Yes. This would clarify the regulations for any future products that may be sold either as prescription or OTC.
Commenter Organization Name: Holden, Karen
Comment Number: 2005N-0345-EC895
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
If a there is evidence that a prescription drug poses a particular risk to a particular subgroup of the population, then the FDA may impose added restrictions for that group, including marketing the drug simultaneously as OTC and prescription. However, the definition of risk should encompass only safety or efficacy of the particular medication, and should be based on accepted evidence. Any other basis or concern used to deny access to medication to a partcular subgroup is beyond the legitimate interest of the FDA.
Commenter Organization Name: Aengst, Jennifer
Comment Number: 2005N-0345-EC921
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
Yes, the FDA should codify its interpretation of this act, so that it can address the numerous cases of drugs ingredients that are present in both prescriptions and OTC sales.
Commenter Organization Name: Wurtz, Richard
Comment Number: 2005N-0345-EC94
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
YES
Commenter Organization Name: Trubow, Marshall
Comment Number: 2005N-0345-EC95
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Trubow, Marshall
Comment Number: 2005N-0345-EC95
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
Yes-you have already done this. You can obtain Ibuprofen as an OTC 200 mg tablet, but it is also available as a prescription in 600 and 800 mg doses.
Commenter Organization Name: Stockton, Melissa
Comment Number: 2005N-0345-EC99
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Stockton, Melissa
Comment Number: 2005N-0345-EC99
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
yes.
Commenter Organization Name: Temple, Jennie
Comment Number: 2005N-0345-EMC355
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.1 - FD&C Act requires rulemaking
Excerpt Text:
The current definition of a prescription drug is found in the Federal Food, Drug, and Cosmetic Act. Prescription drugs, as explained in the act, are withheld form public consumption and regulated due to the implications that misuse of said drug might have. Failing to expressly define an over the counter drug can be viewed as an inherent flaw of the act, because making assumptions, like the understood definition of an over the counter drug, can be dangerous. Due to the language of section 503(b), the FDA is facing a dilemma of whether or not to initiate a rulemaking to possibly permit the sale of a substance both over the counter and by prescription. The FDA should definitely begin a rulemaking process to clearly define the circumstances under which identical drugs can be sold in different arenas.
Commenter Organization Name: Syed, Misbah
Comment Number: 2005N-0345-EMC368
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
NEW - 3.9.1 - Drug approval examples
NEW - 4.1 - Yes
NEW - 5.1 - Yes
Excerpt Text:
My comment to this advance notice of proposed rulemaking is that the FDA should consider that in certain circumstances, a drug should be marketed both as prescription and over-the-counter. I will address this concern by answering the following questions provided by the Food and Drug Administration, to clarify that yes, a drug can be marketed for both prescription and over-the-counter use. I will also provide arguments for what position the FDA use in rulemaking and what the FDA should incorporate in any proposed rule.
The FDA should initiate a rulemaking code to clarify the interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug and over-the-counter drug form because this section only uses the Federal standard classifying drugs as either prescription or over-the-counter. It also defines what a prescription drug is, ?a drug intended for use by man which because of its toxicity or other potential harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug?. This section does not define over-the-counter drugs. It explains that whatever drug does not meet the standards to make it a prescription drug, is classified as over-the-counter. This section only classifies a drug to be prescription or over-the-counter, but in certain circumstances, the FDA has interpreted certain drugs with the same active ingredients to be marketed as both prescription and over-the-counter. For example Meclizine, which is a prescription for vertigo, but for over-the-counter purposes? It handles nausia with motion sickness. Also Nicotine products like inhalers and nasal sprays, which are prescription drugs, but gums and patches are considered over-the-counter. It brings significant confusion regarding the FDA?s interpretation of section 503(b) because other products like Plan B which is a mourning-after pill is also over-the-counter, but to women 17 and older, otherwise it would be a prescription to those women younger than 17. The section clearly does not define rules about age limits and the agency has not figured out how to prevent younger teenagers from gaining access to the pill. It would then be necessary for the FDA to propose a rulemaking solution for this issue to help dispel the confusion.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
NEW - 6.1 - Yes
NEW - 8.1 - Yes
Excerpt Text:
In regards to the FDA?s request for comments on the advance notice of proposed rulemaking for the simultaneous marketing of drugs with identical active ingredients as both over the counter and prescription, I believe that the FDA should proceed with rulemaking to codify its interpretation of section 503 (b), that there is significant confusion in its current state, and that rulemaking would help dispel the confusion that is caused by the current rule. I also believe that the FDA would be able to legally enforce limitations on certain subpopulations and that those limitations could be practically enforced. Finally I believe that it would be legal to sell the products in the same packaging but that there would be some circumstances where selling identical items would be inappropriate.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
The FDA should most definitely codify its interpretation of section 503 (b) to resolve confusion, it can and should place limits on certain subgroups, most notably those underage, and the FDA should also allow the identical packaging of over the counter and prescription drugs but also keep in mind that this is not always appropriate. The current state of the rules regarding prescription and over the counter drugs is inadequate and the FDA should proceed in the rulemaking process.
Commenter Organization Name: Babalola, Abimbola
Comment Number: 2005N-0345-EMC383
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
In our ever-changing society, it is extremely important that the executive branch of the U.S. federal government fulfills its duties of faithfully executing laws that will benefit the lives of the people of our nation. By employing the law, U.S. federal agencies such as the Food and Drug Administration (FDA) officially announce vital rules on a daily basis to more thoroughly describe how U.S. statutes will be applied to specific circumstances. But, these rules are often politically controversial, requiring agencies to explain the reasons for their rules through the benefit of written public participation. Such is the present case with the FDA, as this agency is seeking public comments in response to their Advance Notice of Proposed Rulemaking (ANPRM) (Docket No. 2005N-0345) in dealing with the issue of what types of drugs may be sold simultaneously both by prescription and over-the-counter products. If the FDA initiates a plain-language rulemaking without using complicated and confusing speech in any proposed rule, and for this issue, then drugs that are marketed in both prescription and over-the-counter (OTC) drug products will provide easy access to consumers, will decrease the number of unintended pregnancies in women in the case of the Plan B pill, and will be more affordable to consumers nation-wide.
Commenter Organization Name: Vu, Tram
Comment Number: 2005N-0345-EMC397
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
In order to codify its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an over the counter (OTC) drug product, the Food and Drug Administration should initiate a rulemaking. Codifying section 503(b) set specific standards that pharmaceutical companies can conform to so that there is no ambiguity in the ways drug companies can supply an active ingredient in both markets. Also made clear would be the conditions under which a drug is to be administered and sold. Established criterion and explanation protects consumers as well as eliminates carelessness of pharmaceutical companies on their pursuit to drop new drugs into the market.
For instance, if a new drug were put on the market with active ingredient 'n,' the drug companies would have to comply to more explicit standards and regulations enforced by the FDA in order to market the drug as a prescription and/or OTC product. Further, codified interpretations of section 503(b) would ensure standardized distribution under law. Providing concrete interpretation eliminates loopholes in which the drug companies may use to their commercial advantage.
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
In response to questions A and B, GSK CH does not believe that FDA should initiate rulemaking to codify its interpretation of section 503 (b).
Commenter Organization Name: University of California, San Franscisco
Comment Number: 2005N-0345-C320
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
The Food and Drug Administration (FDA) has the authority to switch a prescription drug to over-the-counter (OTC) status if the drug is both safe and effective when self- administered; potential users can self-diagnose the condition for which the drug is needed; and, the drug's label provides clear instructions for use. Though Plan B meets all of the criteria for OTC status, the FDA has failed to remove its prescription requirement and instead has launched down a path of bureaucratic indecision that does not serve U.S. women. The FDA has no scientific basis for discriminating the safety of Plan B among women of reproductive age. We strongly urge the FDA to abandon the proposed rulemaking process and approve the original application to switch Plan B to an OTC product without restrictions.
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 3.6.2 - Court case arguments opposing a rulemaking
Excerpt Text:
The legislative history of the Durham-Humphrey Amendments, as recorded in Senate Report No. 946, notes that the "not safe" language in the statute is intended to have its ordinary meaning. See 1951 U.S.C.C.A.N. 2,454 at 2,457 and 2,461. If the Agency has determined that a certain drug product is "not safe" for use except under the supervision of a licensed physician, then carving out a subpopulation (by age, for example) would run counter to this "ordinary meaning" -not safe is not safe, regardless of age. Drugs would not be safe for self-medication if "their unsupervised use may indirectly cause injury," as in the case of drug products that contain potent steroid hormones which affect many organ systems. 1951 U.S.C.C.A.N. 2,454, 2,457. See also 35 Fed. Reg. 9,001 (June 11, 1970). In fact, courts have historically noted the safety risks particular to oral contraceptive prescription drug products. Cf. Turner v. Edwards, 1969-l 974 FDLI Jud. Rec. 471,472 (D.D.C. 1970) (stating that "oral contraceptives are prescription drugs, and therefore subject to different requirements as to their use and dispensation than over-the- counter products").
We further note that the legislative history supports the broad applicability of classifying a drug as an Rx product due to the concerns of safety for such drug products. In addressing the concerns in relation to the Durham-Humphrey Amendments, our legislatures made clear that "the broad language of the definition contained in [these provisions] is intended to comprehend all drugs that in fact should be administered under medical supervision in order to insure [sic] their safe use." 1951 U.S.C.C.A.N. 2,454, 2,462 (emphasis added). This Congressional intent on making the definition of a prescription drug apply as broadly as possible is precisely why the statutory language makes sweeping reference to "toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use." See 21 U.S.C. § 353(b)(l)(A). Allowing the marketing of a drug product as OTC based solely on the age of a subpopulation would run counter to the Congressional intent of drafting the statutory language in this broad way.
Commenter Organization Name: Family Planning Advocates of New York State
Comment Number: 2005N-0345-C61
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
NEW - 5.2 - No
Excerpt Text:
In response to the questions posed in RIN 0910-AF72, FPA believes the first three questions (lA, 1B and lC) should be answered in the negative, making it unnecessary to address the remaining questions. We do not believe there is any confusion over the interpretation of section 503 of the Federal Food, Drug, and Cosmetic Act.
Commenter Organization Name: Family Planning Advocates of New York State
Comment Number: 2005N-0345-C61
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
The mission of the FDA is to protect "the public health by assuring the safety, efficacy, and security of human and veterinary drugs.. . ," not to pander to politically motivated opposition where objections have no grounding in medical or scientific research. Because the questions posed in the Request for Information are not the result of medically supportable facts that necessitate placing age restrictions on the medication's USC, it is simply inappropriate for the questions to be considered in conjunction with the FDA's consideration of the Plan B application. We do not support initiating a rule-making process in relation to Plan B.
Commenter Organization Name: Alterton, Faith
Comment Number: 2005N-0345-C83
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
NO.
Commenter Organization Name: Ladd, Judy
Comment Number: 2005N-0345-EC1032
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
To use an ingredient in both OTC and by prescription only muddies the water as to who will receive what and in what form and intensity (dosage). It should be OTC only to assure that if someone wants it, it's available.
Commenter Organization Name: Shaffer, Kathleen
Comment Number: 2005N-0345-EC106
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
It is a contradiciton to sell an active ingredient simultaneously as a prescription drug and an OTC drug product. Therefore the FDA has no authority to attempt to codify its interpretation of section 503(b), thereby allowing it.
Commenter Organization Name: McCormick, Michelle
Comment Number: 2005N-0345-EC1086
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
It makes very little sense, if the drug is nessisary to the welfare of thousands of American women, to limit and restrict the access to said drug. The FDA needs to base rules on the health & well being of Americans, not politically motivated "interpretations" of sections and codes.
Commenter Organization Name: Roye, Carol
Comment Number: 2005N-0345-EC110
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 10 - Studies/data provided in comment
Excerpt Text:
There is no reason to do this in the case of Plan B. There have been well-done studies that show that Plan B does not promote irresponsible sexual behavior by teenagers. In fact, several studies found that giving Plan B to sexually active teens at routine visits actually encourages more responsible condom use. I refer you to (among others):1) Raines T et al (2005, Jan. 5). Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: A randomized clinical trial. JAMA, 293, 54-62; 2)Gold, M.A. et al. (2004). The effects of advance provision of emergency contraception on adolescent women's sexual and contraceptive behaviors. Journal of Pediatric and Adolescent Gynecology, 17, 87-96; 3)Roye C. & Johnsen, J. (2001). Routine provision of emergency contraception to teens and subsequent condom use: A preliminary study. Journal of Adolescent Health , 28, 165- 166.
Commenter Organization Name: Slee, April
Comment Number: 2005N-0345-EC121
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
No. There are two reasons to have a drug available by prescription. One is so insurance covers it, like blood glucose test strips. The other is that a reasonable person can't be expected to take it safely and correctly without the direction of a doctor. On this second part, either a drug is safe enough or it isn't. Besides, anyone who is 15 is smart enough to get a 16 year old friend to buy it for them.
Commenter Organization Name: Severance, Peter
Comment Number: 2005N-0345-EC135
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
No. Why are you complicating this? The FDA is supposed to regulate drugs based on clinical evidence, not make social policy.
Commenter Organization Name: Jones, Kim
Comment Number: 2005N-0345-EC16543
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
Please note that APhA is not responding to these questions in the context of a single drug product; rather, we are providing our comments on the overall "dual status" issue which could apply to any number of drug products. As such, pending issues need not necessarily be resolved by rulemaking before the Agency acts on a specific pending application.
Commenter Organization Name: Hein, Rachel
Comment Number: 2005N-0345-EC168
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
no...drugs cleared for OTC usage should not have additional restraints of prescription requirements based on age. But instead should have clearly labeled information for dosage and dangers, especially when applied to minors.
Commenter Organization Name: Pinkerton, Mike
Comment Number: 2005N-0345-EC171
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
No. I believe that the interpretation is overly restrictive and ignores situations such as this (appropriate for a sub-population)and should not be codified. Case by case determination is more appropriate.
Commenter Organization Name: Pinkerton, Mike
Comment Number: 2005N-0345-EC171
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
No. The interpretation is too restrictive
Commenter Organization Name: Murphy, Cynthia
Comment Number: 2005N-0345-EC176
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text: