FDA Nominee’s Future Hinges on Pill

WASHINGTON —  Two years ago, the Food and Drug Administration indicated that only those 16 and older could safely use the morning-after birth control pill without first getting a doctor’s prescription. Last year, the agency drew the line at 17. This week, the FDA proposed another change: women 18 and older.

Those shifting age requirements prompted questions Tuesday for acting FDA Commissioner Andrew C. von Eschenbach, who faced skeptical Democratic lawmakers during a Senate hearing on his nomination to be the agency’s permanent chief. A vote by the Health, Education, Labor and Pensions Committee has not been scheduled and is not expected until next month at the earliest.

“It’s a cut point, and you have to have some cut point,” said von Eschenbach, responding to Sen. Jack Reed (D-R.I.) about why the FDA commissioner picked 18 as the latest proposed age requirement.

Von Eschenbach suggested that he had settled on 18 partly because it was also the minimum age to purchase tobacco legally in the U.S. But Reed was not convinced.

“It just seems to me the line you are drawing is arbitrary,” he said.

Most Democrats and Republicans agree that the FDA needs a permanent commissioner to confront a host of pressing problems. They also agree that von Eschenbach’s confirmation will depend on how he handles a single, symbolic issue: the long-delayed, politically charged decision on the morning-after pill, also known as Plan B.

Religious conservatives oppose allowing its sale without a prescription, which they say could encourage promiscuity and sexual exploitation of young girls. FDA medical reviewers and a panel of outside experts have recommended over-the-counter status regardless of age.

Plan B consists of two pills containing a high dose of a contraceptive hormone. It can prevent pregnancy if taken within 72 hours after unprotected sex.

The FDA’s refusal to reach a final decision on Plan B has led several prominent doctors and academics to question whether the agency has compromised its scientific independence. From 1994 to 2004, the FDA approved 67 medications for sale without a prescription; Plan B was the only one that was denied approval.

“You are caught, unfortunately, in a situation that gives great pause to many of us because of what it means for the future of the FDA,” Sen. Hillary Rodham Clinton (D-N.Y.) told von Eschenbach. “It has been turned into a political football, and you are on the field.

“Once we start to politicize the FDA, there is no stopping,” she continued. “This is a slippery, dangerous slope we are on, Doctor, and we are looking to you to get a decision made.”

Clinton and Sen. Patty Murray (D-Wash.) have placed a hold on von Eschenbach’s nomination, blocking a floor vote until the FDA makes a decision on Plan B.

Von Eschenbach, 64, a prominent prostate cancer surgeon from Texas and past director of the National Cancer Institute, said he would not take political orders on scientific matters. “No one told me what I could or should do,” he said.

On the day before his hearing, von Eschenbach released a letter to Barr Pharmaceuticals Inc., the maker of Plan B, seeking a compromise and promising a quick decision. But getting an agreement would seem to hinge on the company’s ability to convince the FDA that it can keep the drug out of the hands of those younger than 18.

Democrats questioned whether the company should bear such compliance responsibilities, with Clinton suggesting it would be akin to local police holding brewers responsible for enforcing laws on underage drinking.

If the impasse over Plan B is not resolved, President Bush could bypass the Senate and appoint von Eschenbach during a congressional recess. Such an appointment would be temporary, and von Eschenbach would lack the clout that comes with Senate support.

Von Eschenbach did not give a firm answer when Clinton asked whether he would accept a recess appointment. But the committee chairman, Sen. Michael B. Enzi (R-Wyo.), said the administration would gain little by taking that route.

“You really need to have full authority when you’re running one of these agencies so that you’re not impaired in what you can do,” Enzi said.