"FRC Lawsuit Accuses FDA of Politicizing Women's Health"

In a very interesting move, Family Research Council and Friends are suing the FDA over the dual-classification of Plan B as both prescription for people under 18 and over-the-counter for others. Here's the summary from an email I received entitled, "The Birds and the Plan Bs":

Last summer, the Food and Drug Administration approved the morning after pill, Plan B, for use as an over-the- counter (OTC) drug. However, they kept the drug's prescription (Rx) status for those under 18. This OTC-Rx split for the same product is unprecedented and illegal, and we said so at the time. Yesterday, the Family Research Council, Concerned Women for America, the Association of American Physicians and Surgeons, and others filed a lawsuit against the FDA asking that the U.S. District Court rescind the FDA's approval. Our complaint also states that Senators Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) applied improper pressure on the FDA. Clinton and Murray placed potentially permanent "holds" on acting FDA Commissioner Andrew von Eschenbach's nomination to lead the FDA. After the FDA reversed its position on Plan B, the holds were lifted, and the nominee was eventually confirmed by the Senate. We also argue that Plan B's labeling is inadequate because testing revealed that only 67% understood that Plan B is not a replacement for regular methods of contraception. This suit marks the first time that FRC has participated in litigation to challenge an administrative agency's action we deem unlawful. To read more about the suit, which was featured in today's Washington Times.

The report from PR Newswire contains the main points of the complaint:

• The data submitted by Plan B's owner did not establish that it is safe or effective.
• 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.

While there's kind of the obvious (at least I think) possibility of an immediate dismissal for lack of standing (unless bringing suit against a government agency only requires citizenship in that government), this kind of appears to me to be a case of biting the hand that feeds. Weren't most of the FDA stallings and the end result of the prescription/OTC split directly due to the lobbying efforts of "pro-family" organizations and intervention by the Bush administration without which the drug may have been approved entirely for OTC use?

It will be interesting to see what kind of a response this gets from NARAL and Planned Parenthood as well as how many FDA personnel jump out their windows finally unable to take the schizophrenic nature of pro-family agencies' demands. Speaking of response, might there be any reason FRC decided to bury this on a Friday news-cycle? Or do they even consider it "burying" if their main constituency has a regularly scheduled weekend meeting, or two?

Links to:
The Washington Times--"Family groups sue FDA over contraceptive"
PR Newswire--"FRC Lawsuit accuses FDA of Politicizing Women's Health"
Download copy of the suit, as filed, from FRC's website