Senate Health Democrats Press Crawford For Plan B Decision Timeline

Senate Health Committee Democrats are asking to meet with FDA Commissioner nominee Lester Crawford to discuss the Rx-to-OTC switch of emergency contraceptive Plan B prior to voting on his confirmation.

Discussion of the agency's handling of Barr's Plan B (levonorgestrel) switch application figured prominently at the Health Committee's March 17 confirmation hearing on the acting commissioner's nomination for the permanent post.

Sen. Patty Murray (D-Wash.) implied a decision, or a promise of a decision on the switch, would affect her vote on Crawford's nomination. Murray's home state pioneered behind-the-counter pharmacist prescribing of emergency contraception.

"Will this committee know by the time we vote on your confirmation...April 13, either what that decision is or an exact timeline of when that decision will be made?" she asked.

"I can't commit to that," Crawford responded.

Crawford did agree to hold a briefing for a group of senators who expressed concerns about the Plan B application and committee leadership prior to the vote.

Crawford was reluctant to discuss details of Barr's application or the complexity of the potential approval given the pending review, but said he would discuss the details in the private briefing.

The proposed briefing would include Sens. Hillary Clinton (D-N.Y.), Barbara Mikulski (D-Md.) and Murray, along with committee leaders.

FDA rejected Barr's original application in May, despite an advisory committee vote of 24-3 in favor of a switch. The agency cited a lack of data on the drug in adolescent populations (¹ (Also see "Plan B “Not Approvable” Decision Puts FDA, CDER Director In Hot Seat" - Pink Sheet, 10 May, 2004.), p. 6).

Barr reapplied in July with a dual marketing plan: the drug would be sold OTC for women age 16 and older, but require a prescription for women under 16. FDA missed the Jan. 21 PDUFA deadline to issue a decision on the second application (² 'The Pink Sheet' Feb. 7, 2005, In Brief).

Committee members revived what has been a highly politicized debate on the Rx-to-OTC switch candidate and FDA's review of the submission.

Ranking Member Edward Kennedy (D-Mass.) said there are "serious concerns the FDA was guided more by ideology than sound science."

Kennedy pressed Crawford for a timeline on a decision: "Are we talking days, are we talking weeks?"

"I wouldn't want to say days, senator; I would say weeks," the acting commissioner replied, adding that the delay is due in part to the unique nature of the application.

"In this case it is very complex. We have a kind of application that the company is seeking that we have never approved before, and so it is taking a little longer than it would have in the past."

Crawford suggested that a lawsuit filed over FDA's rejection of Barr's initial application may also be impeding approval. The Center for Reproductive Rights filed suit in January, claiming FDA is holding Plan B to a different standard than other switch drugs.

"The lawsuit has complicated it a little bit: it is for the prior approval, and what effect it has on it, I can't really say at this time," Crawford said. "I don't think it is going to be a long delay....It's a very complex approval process that the company has proposed, and we're working through the legality of that."

Crawford's comments indicate the agency is grappling with communicating Barr's dual marketing proposal through the product labeling.

"I think the science part is generally done, we're just now down to what the label will look like. This is going to be a very unusual sort of approval, and it is delayed, and I apologize for that."

Clinton asked Crawford for assurance the decision would be based in science, not politics. "I am hopeful that we will reverse what appears to be a dangerous slide into political opinion as opposed to scientific evidence," she declared.

"I can assure you that this decision will not be based on politics, it will be based on science," the acting commissioner replied.