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Association of American Physicians and Surgeons, Inc.
A Voice for Private Physicians Since 1943
Omnia pro aegroto

WHO, WHEN: This memo lays succinctly describes the lawsuit that will be filed on Thursday, April 12, 2007 by the American Association of Physician and Surgeons (AAPS), Family Reseach Council (FRC), Concerned Women for America (CWA), and Safe Drugs for Women (SDW).[1]  The suit names both FDA and FDA Commissioner Andrew von Eschenbach, M.D., as defendants.


WHERE: The suit will be filed in U.S. district court in Washington, D.C.


WHAT: This coalition of medical professionals and groups concerned about women's and children's health will file a federal lawsuit against the Food & Drug Administration to overturn FDA's approval of the "Plan B" (levonorgestrel, 0.75 mg) morning-after pill for over-the-counter (OTC) use by women 18 and older.


            The lawsuit alleges the following violations by FDA:


      The data submitted by Plan B's sponsor did not establish that Plan B is safe or effective;


      •       The legal and scientific questions before FDA were whether Plan B OTC switch would be safe and effective as labeled. "Safe" has the broad definition described in Paragraph 31 of the draft complaint. We certainly argue that Plan B's sponsor did not meet its burden of demonstrating that Plan B is either safe or effective.  We focus on the unknown safety effects of taking a high dose of a systemically absorbed hormone during puberty. In addition, the approvability of Plan B as labeled also includes the potential indirect safety effects outside the drug interaction (e.g., women of all ages foregoing "Plan A" contraceptives and therefore missing medical checkups and counseling, misplaced belief in Plan B's efficacy leading to unintended pregnancies.
      •       The label comprehension test for Plan B indicated that fully one in three women (all ages) did not understand that Plan B is not a replacement for traditional contraceptives. Those are the data before FDA, not our opinion (Paragraph 70). In addition, we argue that the label is affirmatively misleading (Paragraph 68), occurs within the context of an effort to sell Plan B as a panacea (Paragraph 71), and does not provide the legally required clear disclaimers to delineate what it can and cannot do (Paragraphs 69, 72).

      FDA lacks authority to approve the same drug for simultaneous OTC and Rx distribution;


      FDA lacks authority to bifurcate Plan B's distribution status based on the patient's age;


      FDA lacks the authority to approve a hybrid "third class" of behind-the-counter drug that is neither fully OTC nor Rx;


      FDA approved Plan B for OTC status without conducting the rulemakings required by both the Administrative Procedure Act and the Federal Food, Drug, and Cosmetic Act; and


      The about-face by FDA and von Eschenbach resulted (or had the appearance of resulting) from improper political pressure from the Congress because Senators Clinton and Murray put Plan B "holds" on von Eschenbach's confirmation.

      • the Senators' hold imposed improper congressional pressure that compromised the validity of FDA's decisions to approve Plan B for dual OTC-Rx distribution and to act without a rulemaking.

Because courts tend to defer to administrative agencies on scientific issues, the first count (safety and efficacy) will be difficult to win. Nonetheless, we wanted to make these arguments to demonstrate the seriousness of the issue:


      FDA's approval ensures that young girls will have unsupervised access to Plan B (as demonstrated by widespread underage access to alcohol and tobacco), notwithstanding that FDA found Plan B unsafe for young girls without medical supervision as an Rx drug.


      FDA failed to require Plan B's sponsor to submit data required by the Pediatric Research Equity Act, which protects children and adolescents.


      The studies submitted to FDA for Plan B demonstrate that consumers simply do not understand the label well enough to self-medicate with Plan B as an OTC drug.


o       First, label miscomprehension makes Plan B particularly unsafe for young women and girls because they do not understand that Plan B does not replace traditional birth control and thus may take it too often;


o       Second, label miscomprehension makes it likely that all women will not use Plan B correctly without Rx distribution.


On August 24, 2006, FDA reversed ground and approved the over-the-counter ("OTC") sale of the "Plan B" morning-after-pill (also, "emergency contraception") to women 18 years old and older.  Females 17 and younger will have to purchase the drug by prescription ("Rx"). 


            The Family Research Council and several other groups filed comments in an FDA proceeding (Nov. 1, 2005) listing reasons that a simultaneous OTC/Rx approval would be unlawful.  We also asserted that creating a new category of drug ("behind the counter drugs") would be unlawful.  Finally, we pointed out that were FDA to issue such an approval, it could do so only after completing a notice and comment rulemaking on various administrative law issues.  There was no such rulemaking before FDA's decision, so FRC intends to sue FDA claiming that its Plan B approval violated federal law.  


            This litigation intends to reverse FDA's decision so that a prescription is required for all Plan B sales or, failing that, to require a rulemaking that will address the legal questions raised.

[1]  SDW is a new non-profit formed to represent medical professionals and consumes with concerns over the safety of reproductive health drugs approved by FDA. Through its membership, SDW represents more than 2000 physicians and approximately 1000 pharmacists in virtually every state.