Comments re: Docket No. 2005N-0345, RIN 0910-AF72
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.

The Association of American Physicians & Surgeons (AAPS) is a nonprofit national group of thousands of physicians. Founded in 1943, we are entirely member-supported and do not accept funding from industry. Courts and medical boards frequently welcome our amicus curiae briefs and letters. Justices of the United States Supreme Court have cited materials we submitted, see Stenberg v. Carhart, 530 U.S. 914 (2000); the Privacy Rule also cited us, see 65 F.R. 82462, 82468 (Dec. 28, 2000). We have successfully sued the Food and Drug Administration (FDA) for exceeding its authority in the past. See Ass�n of Am. Physicians & Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002).

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.

AAPS further observes that the FDA lacks statutory authority to approve a drug for OTC purposes for one age group while retaining prescription requirements for the same drug for another age group. If the FDA feels it has such authority, then it needs to promulgate its position in a formal rulemaking procedure, including notice and comment by physicians. For the following reasons, AAPS submits that the FDA lacks such authority to classify the same drug as OTC for one age group but prescription use for another.

Once the FDA has determined that a drug requires a prescription, then by definition that drug has a potential for harmful effect. That potential for harm does not change based on whether the recipient is 15 years old, 16 years old, 17 years old or 18 years old. Congress and state legislatures have the sole power to draw distinctions between those ages for the consumption of food or drugs. The FDA does not.

An age-based classification for prescriptions would constitute an intrusion by the FDA into an area of traditional state regulation: parental notification or consent for the medical treatment of minors. If the FDA were to decide that a drug requires a prescription for a 15-year-old but not for a 17-year-old, then such decision would transfer power over issues of consent by minors to the FDA from the states. Nothing in Section 503(b) or elsewhere gives the FDA such authority to decide at what age a minor is mature enough to buy OTC drugs that have life-changing effects.

The possibility that a state could regulate the age at which a minor could purchase an OTC drug does not satisfy our objection. States have regulatory schemes that are not designed for, or equipped to, deal with the illegal distribution of OTC drugs to minors. In the case of reproductive activity, adult men are often responsible for victimizing and impregnating much younger girls. The adult men could and often would circumvent any age requirement on the purchase of the OTC drugs by underage girls. The FDA should not propose an age requirement for OTC drugs unless it has adequate means and resources to enforce it. It does not.

Our concerns are heightened in the context of teenagers confronting sexual reproduction. They often lack the maturity and financial independence of adults to make informed decisions about their health and well-being. Teenagers are highly susceptible to peer pressure and misinformation denying possible long-term adverse effects of interference with a pregnancy. It is wholly unrealistic to suggest, as some have, that a �morning after pill� made available on an OTC basis to 16 or 18 year-olds will not be widely distributed to younger girls. As an organization of physicians who must deal with subsequent medical harm, AAPS objects to an age-based classification allowing OTC sales of a morning after pill.

AAPS reminds the FDA that the states require parental consent for most medical decisions made by minors. California, for example, just reenacted its requirement of parental consent for body-piercing of a minor. See 2005 CA A.B. 646 (signed by the governor of California on Sept. 22, 2005). The vast majority of states require parental notification or even consent prior to performing an abortion on a minor. Making a drug available on an OTC basis renders parental consent impossible. When a prescription is required for the drug, a trained physician can assess the benefits and harms, and advise a minor and her parent appropriately. When the drug is sold over the counter, there is no professional evaluation or meaningful way for a minor to learn and evaluate the medical harm.

AAPS emphasizes that childbirth confers undeniable health benefits on the mother, and interruption of a pregnancy is indisputably harmful compared to childbirth. The FDA should not render any decision concerning increased availability of a drug to interfere with pregnancy without hearing from all sides of the medical community about the harm of preventing childbirth. The medical literature contains many peer-reviewed studies demonstrating how harmful pregnancy termination is to one�s health. See generally J.M. Thorp, Jr., K.E. Hartmann, and E.M. Shadigian, �Long-Term Physical & Psychological Health Consequences of Induced Abortion: Review of the Evidence,� 58 OB/GYN Survey 1, at 67-79 (2003); D.C. Reardon, P.G. Ney, F.J. Scheuren, J.R. Cougle, P.K. Coleman, T. Strahan, �Deaths associated with pregnancy outcome: a record linkage study of low income women,��95 Southern Medical Journal 8, at 834-41 (August 2002) (�Higher death rates associated with abortion persist over time and across socioeconomic boundaries.�); Karen Malec, �The Abortion-Breast Cancer Link: How Politics Trumped Science and Informed Consent,� 8 J. Am. Physicians & Surgeons 41 (Summer 2003) (the vast majority of studies have found that abortion increases the risk of breast cancer), www.jpands.org/vol8no2/malec.pdf (viewed Aug. 3, 2005). A morning after pill can be expected to cause harm and the FDA should not facilitate bypass of informed consent in consultation with a physician. Mixing OTC and prescription classifications for the same drug would thwart informed consent and lead to unanticipated harm to patients.

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.