Senate likely to vote on stalled FDA nomination

WASHINGTON -- Acting Food and Drug Administration Commissioner Dr. Andrew von Eschenbach has enough supporters for his confirmation to be sent to the full Senate next month, according to a key congressional committee chairman .

Senator Michael B. Enzi , Republican of Wyoming , chairman of the Senate Health, Education, Labor, and Pensions, said he has the votes to push the stalled nomination out of committee with or without an FDA decision on whether women can buy the emergency contraception known as Plan B without a prescription.

During a contentious confirmation hearing yesterday, Democratic senators accused von Eschenbach of politicizing the agency's decision-making on whether Plan B could be sold over the counter.

The criticism included the timing of a letter the FDA sent to the drug's manufacturer on the eve of yesterday's hearing, signaling the agency's willingness to approve over-the-counter Plan B sales, subject to conditions.

Edward M. Kennedy , Democrat of Massachusetts , said the letter was ``not a decision, but a framework" that ``moved the goal posts" by further restricting the age at which Plan B could be purchased without a prescription.

Others said the FDA seeks to place an unnecessarily stringent safety hurdle in the path of a drug already shown to be safe and effective. The agency wants Plan B's maker, Barr Pharmaceuticals Inc., to devise a risk management plan of the sort required for medications linked to serious side effects.

Since April 2003, Barr has awaited an FDA decision on whether it would permit emergency contraception sales to women without prescriptions. The drug, a high dose of oral contraceptive, blocks pregnancy when taken within 72 hours after unprotected sex. Initially, Barr sought to sell Plan B without any age restriction. At the direction of the FDA, the company revised its application to sell Plan B over-the-counter to women age 16 and older.

The dispute predates von Eschenbach's tenure at the FDA. But the former National Cancer Institute director still faced harsh criticism from Senators Hillary Rodham Clinton and Patty Murray , whose procedural hold prevents a vote on his nomination by the full Senate.

Murray , a Washington Democrat, chided von Eschenbach for lacking a scientific basis for changing the target group for over-the-counter sales to 18 and older. The FDA said last year that Plan B was safe enough to be sold without a prescription to women 17 and older, but delayed action as it solicited and sorted through 47,000 public comments on the issue.

``This is why this is so startling to all of us," Murray said.

Clinton , a New York Democrat, said the FDA steadily has become more politicized, taking the agency down a ``slippery, dangerous slope." She warned: ``We're drawing the line right here."

Von Eschenbach assured the panel that this week's letter to Barr reflected his decision-making alone. ``No one told me what I should or could do. No one told me what decision I must or must not make," he testified.

Enzi is counting on such supporters as Kennedy to push the vote through committee next month. Enzi and Kennedy are poised to introduce bipartisan FDA reform legislation and used yesterday's hearing to underscore the need for sweeping change.

``This agency is really in trouble, and some would even say in crisis," Kennedy said.

Diedtra Henderson can be reached at dhenderson@globe.com.