2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC951
Submitter : Ms. Kathryn Brass Date & Time: 10/27/2005 08:10:20
Organization : Ms. Kathryn Brass
Category : Health Professional
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?
No. The FDA?s interpretation of this rule has, up until this decision, been consistent for many years; care needs to be taken that political pressures are not entered into the interpretation, but the rule itself is straightforward. Furthermore, the unnecessary process of codifying new rules will only prolong Plan B coming to market as an over-the-counter medication. There are numerous examples of discretionary drugs (nicotine, alcohol) that are marketed to/available only to subpopulations; they provide more than enough precedent to move forward with the ruling without codifying it.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The only confusion resulting from the FDA?s interpretation of this section of the act stems from the FDA?s deviation from precedent established by our scientific understanding of drug effects on women of reproductive age. In every previous ruling, the FDA has considered women of reproductive age as one group when looking at the safety and efficacy of a product. The arbitrary separation here into ?adolescent? women and ?adult? women is unsupported by the scientific literature, particularly in light of studies which find no differences in the frequency or risk of unprotected sex in young women provided emergency contraception in advance. On the contrary, these teens are more likely to use emergency contraception with unprotected coitus, and to use it earlier after the event, making it more effective. In addition, no decreases have been seen in consistent condom use in the teens that had unrestricted access to emergency contraception. Furthermore, studies in both the US and the UK indicate that teens are not more likely to use emergency contraception as a regular birth control method, nor are they more likely to engage in risky sexual behavior as a result of improved access to the drug.
1. Raine T, Harper C, Leon K, Darney P. Emergency contraception: advance provision in a young, high-risk clinic population. Obstet Gynecol. 2000;96:1?7.
2. Gold MA, Wolford JE, Smith KA, Parker AM. The effects of advance provision of emergency contraception on adolescent women's sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol. 2004;17:87?96
3. Glasier A, Baird D. The effects of self-administering emergency contraception. N Engl J Med. 1998;339:1?4
4. Ellertson C, Ambardekar S, Hedley A, Coyaji K, Trussell J, Blanchard K. Emergency contraception: randomized comparison of advance provision and information only. Obstet Gynecol. 2001;98:570?575
5. Jackson RA, Bimla Schwartz E, Freedman L, Darney P. Advance supply of emergency contraception. Effect on use and usual contraception?a randomized trial. Obstet Gynecol. 2003;102:8?16
6. Belzer M, Yoshida E, Tejirian T, Tucker D, Chung K, Sanchez K. Advanced supply of emergency contraception for adolescent mothers increased utilization without reducing condom or primary contraception use. J Adolesc Health. 2003;32:122?123
7. Blanchard K, Bungay H, Furedi A, Sanders L. Evaluation of an emergency contraception advance provision service. Contraception.
8. Cicely Marston, Howard Meltzer, Azeem Majeed. Impact on contraceptive practice of making emergency hormonal contraception available over the counter in Great Britain: repeated cross sectional surveys. BMJ, doi:10.1136/bmj.38519.440266.8F (published 11 July 2005)

C. If so, would a rulemaking on this issue help dispet that confusion?
Rulemaking on this issue is unlikely to help dispel the confusion mentioned above, as the confusion stems largely from the FDA?s arbitrarily redefining the population of reproductive-age women, and moving away from precedent, not from an incomprehensible or ill-defined law.
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?
As mentioned above, such limitations on alcohol and tobacco are widespread and enforceable. State and Federal bodies alike have engaged in enforcing laws such as the one the FDA proposes, and it would not be outside the legal powers of the FDA to both impose and enforce this law.
B. If it could, would it be able to do so as practical matter and, if so, how?
As a practical matter of enforcement, a fines system could be set up to punish those who violate the distribution laws that result from this ruling. Requiring photo ID from consumers for sale of such products would be an obvious first step. Precedent for this in the pharmaceutical industry already exists in many states ? the sale of over-the-counter pseudoephedrine is now often restricted to those over 18 and requires showing a photo ID. Periodic ?stings? with underage-looking consumers (similar to those performed in bars and convenience stores) would provide sufficient deterrent for selling to ?minors.? While the issue of older friends and acquaintances buying the products for minors remains, this is a challenge for practical enforcement of any law that subdivides a population into those who can and cannot purchase certain products.
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?
One might conclude that the two products should not be sold in the same package in order to differentiate those purchased with a prescription and those purchased over the counter. However, the likelihood that a young teen will be caught standing on the street corner with her non- prescription-style package of emergency contraception is low, and the idea is absurd. There is no logical reason for these two products to be packaged differently, as the dosage and usage are exactly the same. Claritin is currently offered over the counter, but some patients continue to obtain prescriptions in order to purchase it at a reduced price with a co-pay, and these packages do not differ. In fact, separate packaging might encourage consumers to think (erroneously) that the two are different or should be used differently.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
This latest delay in bringing Plan B to the over-the-counter market is absurd and flies in the face of scientific evidence-based medicine. The
previous decision on Plan B was made with complete disregard for the wealth of literature regarding how Plan B might be used. This current decision on Plan B has made a regulatory mountain out of a molehill in an attempt to impose new rulemaking and delay the advent of Plan B as an OTC drug even further, despite its proven safety and efficacy.

The entire purpose of the Food and Drug Administration is to serve as the unbiased evaluator of drugs and devices ? to mediate and mitigate the influences of all parties who might want to take advantage of the consumer for their own gain, or who might unwittingly impose significant risks on any given patient population. In the current climate, the FDA cannot afford to continue to lose the public trust by politicizing this issue. Already the public is wary of the FDA?s commitment to their health, and indefinite foot-dragging on the issue of emergency contraception does not do the FDA?s public image any favors.

As a medical professional in training, I am ashamed that such obvious political interference should have a place at the FDA. The governmental agency designed to protect the American public with regard to what they put in their bodies should be above such games. By proxy, health care providers, too, will bear the brunt of patients? mistrust in the FDA ? we must prescribe medications ?approved? by the FDA, and patients will wonder how confident we can really be about those drugs.

Move forward on the Plan B application, and dispense with the politics. The resignation of Susan Wood is evidence enough that something is drastically wrong at the FDA, and the public needs reassurance that the agency will put science over politics, public interest over political agenda. Plan B belongs on drug store shelves where it can be utilized to reduce the number of unintended pregnancies in the US, a number that far exceeds any other country in the developed world. As a physician in training, I implore the FDA to reconsider this ruling and move forward on the Barr application.