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 : EC1129
Submitter : Ms. JoAnn Paslawsky Date & Time: 10/27/2005 02:10:10
Organization : Ms. JoAnn Paslawsky
Category : Drug Industry
Issue Areas/Comments
1
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?
As a chemist, I am all too familiar with the exceptions that occur despite the industry's best pre-marketing testing and post-marketing surveillance. Thus, I believe that it is virtually impossible to codify interpretation of section 503(b). I believe strongly that simultaneous marketing of an active ingredient in both prescription and OTC form must be assessed on a case-by-case basis. Otherwise, I believe both patient safety and industry's liability are placed at major risk.
1.
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?
As a chemist, I am all too familiar with the exceptions that occur despite the industry's best pre-marketing testing and post-marketing surveillance. Thus, I believe that it is virtually impossible to codify interpretation of section 503(b). I believe strongly that simultaneous marketing of an active ingredient in both prescription and OTC form must be assessed on a case-by-case basis. Otherwise, I believe both patient safety and industry's liability are placed at major risk.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I do not believe there is confusion on this point. The FDA has worked diligently to ensure clarity of its interpretations whenever it makes a decision. I believe the media can and often do create confusion in the manner it reports on scientific matters in general and health topics in particular.
C. If so, would a rulemaking on this issue help dispet that confusion?
No, I believe a rulemaking would simply provide additional opportunities for clouding the issue when it is conveyed to the public.
2
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?
For those bent on obtaining a drug (whether prescription or OTC), there is ALWAYS a way to get the drug, regardless of legal restrictions. Examples abound in this area.

However, since legal restrictions on pharmaceuticals exist largely to prevent patient harm, and such restrictions have historically been successful, I think it would be quite logical and generally effective to enact and enforce a prescription only requirement for a subpopulation on an OTC product.
B. If it could, would it be able to do so as practical matter and, if so, how?
If, for example, the OTC product required a prescription for minors (i.e., under age 18), the pharmacy could simply require photo ID showing DOB, such as on a driver's license. It is currently done for cigarettes, why not a drug?
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?
Since prescription medications are provided with complete instructions, including warnings related to possible AEs, drug interactions, etc., the OTC product should provide the same information. In addition, if there is no difference in the formulations, including amount of the active ingredient, then they should not require different packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Different packaging should only be needed when formulations differ, including but not limited to active ingredient.
GENERAL
GENERAL
As this relates to Barr Labs Plan B, I strongly believe that a decision to make this drug available OTC creates unnecessary risk to women's health and safety. This is especially true for females under age 18, those who cannot read or read poorly, and those for whom English is a second language. In other words, those women already victimized and most at risk.

By approving Plan B for sale OTC, the agency, which bases its guidance and decisions on patient safety, would place these women at even greater risk.

As an OTC drug, anyone would have access to it. This would include those trading sex with children for drugs, those holding children in abusive relationships, and adult men (age 18 or over) preying on minor girls. Please do not open a new door for sexual predators.

Women still suffer a stigma when reporting rape. It is even more difficult to successfully prosecute rape, incest, and sexual abuse. Do not offer another tool to these criminals.

Those who truly care for women and their health (physical as well as emotional) would NEVER allow Plan B to become an OTC drug for the reasons I've cited.

Studies, including those by Barr Labs itself (Jan. 2004 JAMA) have shown that easy access to the morning-after-pill has not decreased abortions or pregnancies.

The main driver for seeking this approval is greed. Planned Parenthood stands to make $100 million profit over a 5-year period on the sale of the
morning-after-pill, provided the FDA approves its OTC sale. Even without the OTC approval, Planned Parenthood has already made significant profit from the drug, thanks to a partnership with Women's Capital Corporation. A year after FDA's approval of the prescription sale, Planned Parenthood had already sold 100,000 units. When Women's Capital Corp. asked the FDA for OTC status for the drug, Barr offered to buy the Corporation, and did so in February 2004, for nearly $21 million.

Before you make the decision, please send people to Planned Parenthood locations around the country. See who the clients are. You will realize they are the women I mentioned earlier - poor, uneducated, victims.

As a woman, I ask you to PLEASE do NOT allow OTC sale of the morning-after-pill. To do so means that the agency is ignoring the risks posed for greater sexual exploitation. I am angered by the so-called 'women's groups' who support this approval while ignoring the growing abuse of women. These same 'women's groups' NEVER use the media as widely or vehemently to demand greater funding for breast, ovarian, or uterine cancer research, or for greater protection and assistance for single mothers and abused women and girls.

I trust the FDA will continue to guard patient safety as its primary and highest goal. Please act to protect women and their health - not the sexual and corporate predators.

Thank you!