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FDA Sued Over Unlawful Approval of Morning-After Pill

Coalition of medical professionals and family groups ask court to reverse FDA's decision

WASHINGTON, April 16, 2007 (LifeSiteNews.com) - A lawsuit was filed April 12 in Federal Court seeking to overturn the Food and Drug Administration's (FDA) unprecedented approval of the morning-after pill, Plan B, as both non-prescription and prescription based on the age of the buyer.

The lawsuit was brought by the American Association of Physicians and Surgeons (AAPS), Concerned Women for America (CWA), Family Research Council (FRC) and Safe Drugs for Women. The suit argues that the FDA committed numerous violations to approve the drug due to extreme political pressure exerted specifically by Senators Hillary Clinton (D-NY) and Patty Murray (D-WA).

CWA President Wendy Wright said, "The FDA buckled to pressure to do something it has never done before - make a high dose of a drug available without a prescription when a low dose of the same drug requires a prescription. The agency skirted laws and regulations put in place to ensure drugs are safe and effective, relenting under undue pressure from political operatives."

The lawsuit makes the case that:

- The data submitted by Plan B's owner did not establish that it is safe or effective. The owner did not test the effects of taking a high dose of hormones during puberty. The FDA did not consider the safety effects on women of all ages, missing medical checkups and counseling that is necessary for the conditions in which Plan B is used. It misleads consumers regarding Plan B's efficacy, leading to unintended pregnancies.

- The trials to test how well consumers understood the label directions showed that consumers do not understand it well enough to self-medicate with Plan B. Fully one-third of women of all ages did not understand that Plan B cannot be used as a regular form of birth control. The label is misleading and does not provide the legally required disclaimers to delineate what it can and cannot do. This makes Plan B particularly unsafe for young women and girls because they do not understand that Plan B does not replace traditional and more effective birth control, and they may take it too often.

- The FDA lacks authority to approve the same drug for both over-the-counter (OTC) and prescription-only distribution.

- The FDA lacks authority to approve distribution based on the buyer's age.

- The FDA lacks authority to approve "behind-the- counter" - a drug that is neither fully OTC nor prescription only.

- The FDA approved Plan B for non-prescription use without conducting the necessary rulemaking required by the Administrative Procedure Act and the Federal Food, Drug and Cosmetic Act.

- The sudden reversal by FDA and Commissioner von Eschenbach had the distinct appearance of resulting from improper political pressure exerted by Senators Clinton and Murray who made clear that they put "holds" on von Eschenbach's confirmation until he acted on Plan B.

- The FDA's approval ensures that girls will have unsupervised access to Plan B even though FDA has found that Plan B is unsafe for girls without medical supervision, as denoted by the fact it is prescription- only for those under 18.

- The FDA failed to require Plan B's owner to comply with the Pediatric Research Equity Act which protects children and adolescents.

This lawsuit seeks to reverse the FDA's decision, placing Plan B back where it belongs: as prescription- only. Barring that, the suit seeks to require a rulemaking procedure to address the legal questions raised.

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