June 14, 2006

The FDA's recent letter rejecting a citizen petition for OTC sale of the controversial contraceptive Plan B is meant to be a legal broadside, heading off Plan B lawsuits by making clear how solid the agency's legal footing is, a legal expert said.

The FDA used a June 9 letter rejecting the Center for Reproductive Rights' (CRR) petition asking the agency to approve Plan B for OTC use to argue that CRR lacks the standing to push the issue in court. CRR, which has filed a lawsuit against the FDA to force it to approve Plan B, does not have the legal authority to act on the company's behalf because there it has no "commercial, financial, associational, fiduciary or confidential relationship with Barr," the letter said.

The agency is "completely correct" in its legal arguments, Peter Barton Hutt, senior counsel at Covington and Burling and former FDA general counsel told DID. The law is clear that a party that lacks any of those relationships with Barr cannot represent its interests in court, Hutt added. "CRR hasn't got a leg to stand on, in my judgment."

The agency's decision to lay out its reasoning is driven by its desire to undermine CRR's ongoing suit against the FDA and discourage future Plan B lawsuits, he said. The agency is "in effect, filing its brief in court ahead of time, trying to head off further litigation."

However, CRR rejects this argument. The letter will have "no impact at all," CRR attorney Priscilla Smith told FDAnews. The court has already established that CRR has standing to challenge the FDA's review when it rejected an earlier government motion to dismiss, she said. The group is not acting on Barr's behalf, but instead is representing doctors and, by extension, their patients who would use Plan B, she added.

By issuing the letter, the agency diverged from its traditional practice of withholding a decision on a citizen petition when a similar supplemental new drug application is pending. A response is warranted in this case, the agency letter said, because of "the significant public interest in the issues raised by your petition."

The agency faces increasing pressure from lawmakers such as Sen. Edward Kennedy (D-Mass.), the ranking member of the Senate Health, Education, Labor and Pensions Committee, to make a decision on the Barr application. Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) had earlier held up Andrew von Eschenbach, President Bush's nominee to be the FDA commissioner, because of the Plan B controversy. (http://www.fdanews.com/did/5_116/)