Morning-After Pill: Politics and the F.D.A.

Among veterans of the battles over drug approvals here, it is hard to find anyone who believes them.

On Friday, the food and drug commissioner, Lester M. Crawford, announced that he would indefinitely postpone a ruling on Plan B, the morning-after pill made by Barr Laboratories. He explained that while the science supported over-the-counter access for women 17 and older, the agency had not figured out how to do that without younger teenagers getting the pills.

While the announcement prompted familiar responses on each side of the abortion debate - protest from abortion rights groups, support from abortion opponents - other veterans of the drug wars sounded more exasperated than anything else.

"At some point, the statute requires that the agency make a decision," said Dr. Eve E. Slater, an assistant secretary of health from 2001 to 2003. "You can't just delay forever."

The Plan B decision has become "overly politicized, and it shouldn't be," Dr. Slater added. Under federal regulations, the Food and Drug Administration was required to reach a decision on Plan B by January. Nothing happened. Indeed, Barr executives said they had no discussions with the agency after January. Usually when the agency is actively considering an application, there is a constant back-and-forth with the company.

As the months passed, two Democratic senators who support abortion rights, Hillary Rodham Clinton of New York and Patty Murray of Washington, vowed to block any vote on President Bush's nomination of Dr. Crawford to become agency commissioner unless the F.D.A. made a decision on the pill, for or against. Mr. Bush has long been aligned with abortion opponents.

The senators relented in July after the secretary of health and human services, Michael O. Leavitt, promised that a decision would be made by Sept. 1. On Friday, both senators attributed Dr. Crawford's latest announcement to political interference.

Dr. Robert Fenichel, a former deputy division director for cardiovascular and renal drugs who left the F.D.A. in 2000, agreed, saying the agency's decisions on Plan B were being driven by abortion politics.

"I've never seen anything like this before," Dr. Fenichel said.

Read More
http://www.nytimes.com/2005/08/28/politics/28pill.html

...late last Friday afternoon, Mr. Crawford announced that the agency would delay approval once again. Citing "novel regulatory issues" and "profound" policy questions, he said that the new application required further study and public comment.

With this statement, Mr. Crawford not only broke his word to two senators, but he also put the agency at risk of losing its credibility. In recent months critics have accused the FDA -- which is required by law to make decisions exclusively on scientific and legal grounds -- of falling victim to outside political agendas. They have claimed that the Plan B decisions have reflected not sound science and legitimate caution but rather the influence of "moral" and antiabortion lobbies claiming that Plan B, which mainly acts by preventing fertilization, might occasionally act by dislodging an hours-old fertilized egg and therefore "aborting" it. By abruptly rejecting an application that had been tailored to meet the FDA's requirements, Mr. Crawford appears to confirm the critics' worst fears.

We don't deny that there are legal and practical difficulties involved in selling the same drug in the same package to different age groups. But the agency has not only had past experience with restricted over-the-counter sales of nicotine and tobacco, it has also had plenty of time to communicate its concerns to Barr and to negotiate a workable system. Whatever the legal arguments taking place, this unexpected delay at this stage of the approval process makes the FDA -- long admired around the world for its neutrality and professionalism -- look like an easily manipulated political tool.

http://www.washingtonpost.com/wp-dyn/content/article/2005/08/29/AR2005082901712.html