WHO, WHEN: This memo lays succinctly describes the lawsuit that will be filed on Thursday,
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:
Ø The data submitted by Plan B's sponsor did not establish that Plan B is safe or effective;
Ø FDA lacks authority to approve the same drug for simultaneous OTC and Rx distribution;
Ø FDA lacks authority to bifurcate Plan B's distribution status based on the patient's age;
Ø FDA lacks the authority to approve a hybrid "third class" of behind-the-counter drug that is neither fully OTC nor Rx;
Ø 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
Ø 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.
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:
Ø 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.
Ø FDA failed to require Plan B's sponsor to submit data required by the Pediatric Research Equity Act, which protects children and adolescents.
Ø 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.
The Family Research Council and several other groups filed comments in an
FDA proceeding (
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.
 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.