Washington Editor

WASHINGTON - Lester Crawford's nomination to permanently head the FDA is moving to the Senate floor, despite dissension from a trio of Democrats.

"Without a Senate-confirmed leader," said Sen. Michael Enzi (R-Wyo.), the chairman of the Senate Committee on Health, Education, Labor and Pensions, "we can't expect the FDA to be as effective as we need it to be."

A majority of committee members agreed with that sentiment and voted to approve the nomination, made by President Bush earlier this year. The appointment remains subject to confirmation by the full Senate, which soon will vote on the matter, though political divisions on Crawford that arose during the committee hearing process could further waylay his nomination.

"I'm afraid, as of right now, that Dr. Crawford may not provide the leadership that FDA needs now more than ever," said Sen. Patty Murray (D-Wash.). She said she would vote to block his appointment on the Senate floor, an action echoed by Sens. Hillary Rodham Clinton (D-N.Y.) and Barbara Mikulski (D-Md.), largely because of their displeasure with the FDA's indecision on the status of an application to make the Plan B morning-after contraceptive available over the counter. They have urged Crawford to speed a decision on the product, for which patients currently need a prescription, but the agency has yet to render a verdict, which Clinton attributed to "a growing politicization of science."

Murray said the Senate should hold off on deciding until receiving a report from the Government Accountability Office related to the Plan B review process, which has gone on months longer than expected. "I fear this case highlights a leadership problem at FDA," she said, "a leadership problem that can be biased or open to undue outside influence."

But Enzi cautioned against blocking Crawford, who was not in attendance.

"I am not sure that the threat to hold up a nomination over one drug application currently under consideration at the FDA is the right way to achieve a faster review," he said, "and to ensure a review process free from the pressures of politics."

Still, Clinton and her colleagues pointed to "an agency marked by controversy" during Crawford's tenure as its acting leader. They questioned his handling of issues related to safety monitoring of approved drugs, matters linking teen suicides to antidepressants, last fall's flu vaccine shortfall and drug re-importation.

"At a time when we need a strong leader," added Clinton, "unfortunately I don't think that's what this nomination represents."

All those gripes also were aired at Crawford's initial confirmation hearing before the committee. Later, allegations of an extramarital affair delayed a vote pending further investigation of that matter, which since has been dismissed. (See BioWorld Today, March 19, 2005, and April 18, 2005.)

Standing apart from his fellow Democrats was Sen. Ted Kennedy (D-Mass.), the committee's ranking member, who said that despite being troubled by ideological intrusions into science on the part of the Bush administration, noted that Crawford "has sufficient background and experience" to assume the agency's top position.

The 66-year-old has been serving as the FDA's acting commissioner for more than a year, prior to which he had a long career at the agency as its deputy commissioner and administrator of the food safety and inspection service. The FDA has been without a permanent commissioner since Mark McClellan left early last year to serve as administrator of the Centers for Medicare & Medicaid Services. (See BioWorld Today, Feb. 23, 2004.)

While Murray, Clinton and Mikulski are working to block Crawford's nomination on the Senate floor, Kennedy declined to speculate whether there were enough votes. Sen. Orrin Hatch (R-Utah) said Senate Majority Leader Bill Frist (R-Tenn.) would have to recognize the opposition, but added that when a vote is taken, he expects at least 61 supporters to approve Crawford.

A Senate confirmation date has yet to be announced.

FDA, BMS Make Changes To Sustiva Label

The FDA and Bristol-Myers Squibb Co. recently publicized a label change to Sustiva (efavirenz), the company's non-nucleoside reverse transcriptase inhibitor indicated for HIV-1 infection.

Health care professionals were notified of revisions to the Warnings, Precautions/Pregnancy and Information for Patients, and Patient Information sections of the drug's prescribing information that resulted from four retrospective reports of neural tube defects in infants born to women with first trimester exposure to Sustiva, including three cases of meningomyelocele and one Dandy Walker syndrome.

As Sustiva might cause fetal harm when administered during the first trimester, pregnancy should be avoided in women receiving Sustiva, the New York company said. Also, an antiretroviral pregnancy registry has been established to monitor fetal outcomes of Sustiva-exposed pregnant women.

Biotechnology Institute Sets Plans For BIO

In advance of next week's Biotechnology Industry Organization international convention in Philadelphia, the Biotechnology Institute will hold its education conference.

The four-day event will bring together teachers and students from around the world to provide educators with materials and skills to incorporate biotechnology into classrooms while informing young people about the field. The meeting will address bioethics, work force development and diversity, as well as include student and teacher competitions and awards, professional development, mentoring and career sessions.

The Biotechnology Institute, an educational spin-out of Washington-based Biotechnology Industry Organization, is aimed at both informing the public about the industry and increasing its work force, which the U.S. Department of Labor has projected to grow to 815,000 workers by 2007.

The Biotechnology Institute is headquartered in Arlington, Va.