Medical Device Daily Washington Editor

WASHINGTON – After a series of delays over the past few months, the Committee on Health, Education, Labor and Pensions voted to send Lester Crawford’s nomination as the FDA’s permanent commissioner to the Senate floor.

Crawford, 66, who has served as the agency’s acting commissioner for more than a year, was nominated by President George Bush back in February. He was not present for Wednesday’s hearing.

Since then, a series of roadblocks has waylaid a decision by the Senate, including questions concerning FDA post-approval surveillance of drugs and devices, drug safety monitoring, mismanaged flu vaccine supplies, and the status of an application to make the Plan B morning-after contraception available over-the-counter (OTC).

Adding to the number of nomination obstacles were allegations of an improper relationship between Crawford and an unnamed female official at the FDA that became public after charges were made anonymously by an agency employee.

The information was leaked to The Washington Post by undisclosed Senate staffers, who said the allegations also include questions about promotions received by the woman in question.

An inquiry requested by Sen. Mike Enzi (R-Wyoming), HELP committee chairman, concluded last week, clearing Crawford of the charges. The investigation was conducted by the inspector general of the U.S. Department of Health and Human Services.

A total of 11 members of the 20-member committee were present for the voice vote. Despite the show of support for Crawford, Sens. Hillary Clinton (D-New York) and Patty Murray (D-Washington) threatened to place a hold on the nomination as it moves to the Senate floor based on the FDA’s handling of the Plan B application.

A hold takes place when a Senator informs his or her party’s floor leader that he or she does not wish a bill or other measure to reach the floor for consideration. The Senate’s majority leader is then on notice that the opposing senator may filibuster any motion to proceed to consider the measure, which has been the subject of much political wrangling over the past few months between Democrats and Republicans in Congress over many of President Bush’s recent nominees.

“I know that some of my colleagues on the committee are not completely satisfied with statements made by Dr. Crawford during his nomination hearing and in a subsequent briefing,” Enzi said. “I am not sure that the threat to hold up a nomination over one drug application currently under consideration at FDA is the right way to achieve a faster review and to ensure a review process free from the pressures of politics.”

More than 60 votes would be needed to override the hold.

Murray and Clinton told the committee they were not advocating a particular decision for Plan B, but suggested the FDA’s decision-making process could be compromised. They also accused the agency of dragging its feet on Plan B, despite having all the necessary data to make a decision for more than a year and not complying with the Prescription Drug User Fee Act.

“I am not asking for a specific outcome, but I’m asking for a final outcome,” Murray said. “I am asking for a leader to make a decision. I am asking FDA to explain why they are delaying an OTC application that even their own advisory panels overwhelmingly recommended for approval.”

Murray said she appreciated Crawford’s willingness to meet with her and other senators, but was “frustrated and disturbed” by the acting commissioner’s unwillingness to “answer the most simple questions” regarding the controversial contraceptive’s approval.

“I share a deep concern that there is a growing politicization of science occurring at the FDA and examples within other agencies,” Clinton said. “We have a solemn responsibility to preserve the integrity of the scientific process in this government. I believe strongly that’s what’s at stake here.”

She said Crawford’s nomination should be examined “in a broader context,” saying that his tenure at the FDA had been “marred by controversy.”

Currently underway is a Government Accountability Office investigation of the FDA’s treatment of the Plan B OTC application. Murray called for committee pressure in expediting the investigation.

“It is important to me to uncover any possible undue influence and to dispel any possible hint of political interference,” she added.

Committee member Sen. Orrin Hatch (R-Utah) said it was important that the FDA have permanent leadership now.

“The sooner he is confirmed, the better, in order to move forward with all the issues we are concerned with in the area of drug and device safety,” Hatch said, calling Crawford “a man of integrity.”

He added: “It is a shame that his name has been dragged through the mud.”

In a bit of a surprise move, ranking committee member Sen. Edward Kennedy (D-Massachusetts) said he would back Crawford’s nomination, saying that it was important that the position of FDA director be filled as quickly as possible.

“When you have an acting chair, you still don’t have the clear-cut decision making that is so necessary,” Kennedy said, pointing out that for three of the last four years, the FDA has been without a permanent head.

He said he was troubled by the “impact of ideology on science” and would support all efforts to get a final judgment on Plan B, but said Crawford had the right kind of experience for the job.

“That said, I will hold Mr. Crawford responsible,” Kennedy said. “But there is a need to try and work with our colleagues to try and resolve this issue.”

Following the hearing, Kennedy told reporters that he was not sure how many of his fellow Democrats would follow his lead, nor was he sure if there would be the votes necessary to block the hold.

Sen. Hatch told reporters that he believed there would be enough votes.

“Let’s face it, he [Crawford] should not be held liable for decisions that have or haven’t been made there since he hasn’t been put in as permanent commissioner,” he said. “And once he is named director, those decisions will have to be made one way or another.”