Senators Prod FDA Nominee On Politicization of Agency
Wednesday, August 2, 2006
Acting Food and Drug Administration Commissioner Andrew C. von Eschenbach struggled yesterday to convince a Senate committee that he deserves to lead the agency on a permanent basis, but his efforts were repeatedly undercut by tough questions about the agency's flagging reputation and its snail's-pace review of the emergency contraceptive pill Plan B.
Without exception, members of the Senate Committee on Health, Education, Labor and Pensions praised von Eschenbach's résumé, which includes a long and successful career at the University of Texas M.D. Anderson Cancer Center and a four-year stint as director of the National Cancer Institute.
"His credentials are impeccable," said Sen. Kay Bailey Hutchison (R-Tex.), introducing the nominee at his confirmation hearing.
But despite -- and in part because of -- von Eschenbach's surprise announcement Monday that the agency is reviving a stalled effort to make Plan B available without a prescription, the surgeon and three-time cancer survivor found himself accused of furthering the politicization that critics say has sullied the agency.
Von Eschenbach reiterated a commitment to "sound science" and to a new climate of openness, but many at the hearing wondered aloud whether the timing of the Plan B announcement, a day before the hearing, was evidence of a political rather than scientific animal at work.
"There is a crisis of confidence at FDA," said Sen. Barbara A. Mikulski (D-Md.), who represents the district that is home to most of the agency's offices and labs.
More than 100 whistle-blower cases are pending at the agency, Mikulski noted -- an outgrowth, she said, of rock-bottom morale, much of it rooted in the perception that the Bush administration is imposing ideology over evidence.
Several senators cited a recent survey by the Union of Concerned Scientists in which more than 40 percent of nearly 1,000 FDA employees said they knew of cases in which political appointees had interfered with agency decisions.
"Once we start politicizing the FDA, there is no stopping it," said Sen. Hillary Rodham Clinton (D-N.Y.). "This is a slippery, dangerous slope we are on, Doctor."
No case before the FDA has been subject to more political controversy than that of Plan B, a mix of contraceptives that can block pregnancy when taken within 72 hours of intercourse. In December 2003, an expert panel voted overwhelmingly in favor of allowing the drug -- long sold by prescription -- to be offered over the counter. But the agency has yet to make a final decision.
Yesterday's hearing focused on two conditions that von Eschenbach outlined Monday in a letter to the drug's maker, Duramed Research Inc., part of Barr Pharmaceuticals of Woodcliff Lake, N.J.
The first of those -- that nonprescription sales be limited to women at least 18 years old -- proved especially difficult for him to defend. As several senators noted, the agency's expert panel concluded that Plan B was safe and effective for all women of reproductive age.
When the agency expressed concerns that younger women might not be able to follow directions for proper use of the pills, the company offered an age limit of at least 16. After further delays, the agency's former commissioner settled on age 17 or older. Von Eschenbach's shift to age 18 struck many senators as arbitrary.
"Is there new data? New analysis? Or have you just decided you don't like the conclusion of your predecessor?" asked Sen. Jack Reed (D-R.I.).
"I believe 18 is appropriate," von Eschenbach said, offering no new data. "It's a cut point. We have to have some cut point."
Noting that 45 countries allow women of any age to buy the drug without a prescription, Sen. Tom Harkin (D-Iowa) said: "You're saying our young women are stupider than the women in these countries."
Republicans on the committee generally sidestepped the Plan B fight, neither questioning von Eschenbach's judgment nor offering explicit support for his proposal.
Also at issue was von Eschenbach's insistence that the manufacturer take responsibility -- perhaps through a contractual arrangement with pharmacies -- for ensuring that younger women don't gain access to the drug. Clinton likened that demand to holding the distillers of alcoholic beverages responsible for bartenders who serve underage drinkers.
The Senate will not vote on his confirmation until at least September. But the debate may be irrelevant if, as some expect, President Bush uses a recess appointment to give him the job this month.