March 1, 2006

A federal court has ordered the FDA to explain why it has yet to decide whether to allow the Plan B emergency contraceptive to be sold without a prescription -- the latest legal setback for the agency over how it has handled the controversial drug.

The U.S. District Court for the Eastern District of New York on Feb. 24 denied the FDA's request to quash discovery requests in a lawsuit brought by the Center for Reproductive Rights (CRR) that seeks an injunction requiring the FDA to approve OTC access for Barr Laboratories' Plan B. This order comes on the heels of another decision by that court denying the government's request to limit discovery.

"Inquiry which includes testimony by agency personnel, including the senior level personnel who overruled the professional staff, is particularly important in this case because the court finds that a strong preliminary showing of 'bad faith or improper behavior' has been made," according to the New York court.

The court order will allow the depositions to be taken from former commissioners Mark McClellan and Lester Crawford, acting Center for Drug Evaluation and Research Director Steven Galson and FDA's Deputy Commissioner for Operations Janet Woodcock. While such testimony is usually restricted under the deliberative process privilege, evidence of bad faith overrides this privilege, the court says.

The plaintiffs also will be allowed to question the agency on the role that groups outside the agency had on its decisionmaking. "Inquiry about contacts between those outside the agency and those within the agency is appropriate to expose whether improper influences led to the FDA's actions," the court says.

The FDA has been under pressure from lawmakers and advocacy groups to approve the drug for OTC use. Critics have argued that the agency has refused to allow OTC use because of concerns that the drug's availability would increase promiscuity among teenage girls. In a recent House hearing, lawmakers accused the agency of "stonewalling" on Plan B and being overly influenced by politics.

Barr first sought OTC status for Plan B (levonorgestrel) in 2003, but the FDA rejected the request, saying the application lacked scientific data on the product's OTC use among adolescents younger than 16. The agency also rejected the advice of an FDA advisory panel that recommended OTC use.

CRR argues the agency is using a moral basis for decisionmaking, which is not part of the agency's science-based mission. Critics also have argued that the agency has been unduly influenced by outside conservative anti-abortion groups.

The agency did not respond by press time. In the past, the FDA has denied politics played a role in the decision to delay approving the drug. Instead, officials have cited the large number of public comments the agency is reviewing along with the complexity of the issue as the reason for the delay.

In issuing its order in the case of Tummino, et al. v. von Eschenbach, the New York district court adopted many of the arguments of the agency's critics on this issue. Specifically, the court agreed that there is substantial evidence that the FDA made its decision to delay the Plan B ruling in bad faith and based on moral, not scientific grounds.

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