- The Washington Times - Wednesday, June 4, 2008

ASSOCIATED PRESS

When pharmaceutical consulting firm Quintiles wants to hire a new employee, the first place it looks is the Food and Drug Administration.

These former insiders bring critical expertise to the consultant and clients like Merck & Co. Inc. and Pfizer Inc., but there is also an unintended downside.

As companies siphon off the FDA’s most experienced scientists, they leave an increasingly leaner, less confident staff that hesitates to put new drugs on the market, analysts say.

FDA’s staffing pains - exacerbated by the departure of baby boomers and increasing competition for science graduates - have caught the attention of lawmakers and consumers, who blame declining inspections for a string of problems with tainted food and drugs.

Over the past two years, Congress has berated the agency on salmonella-infected peanut butter, poisonous pet food and, most recently, the contaminated blood thinner heparin, which has been associated with dozens of deaths.

“What you have now is a big sucking sound of these staffers leaving FDA and going into the more lucrative side of the business or packing it in and retiring entirely,” said Steve Brozak, an analyst with WBB Securities. “This cannot have any positive effect whatsoever.”

FDA repeatedly has rejected criticisms from Wall Street and pharmaceutical companies that drug approvals have slowed in recent years. Instead, the agency says, companies are submitting fewer new drug applications.

FDA’s leadership is scrambling to recruit a new generation of food and drug regulators, as the average age of FDA’s 10,100-member work force reaches 54.

Thirty percent of the agency’s regular staff are already eligible to retire, and the FDA expects to hire 600 staffers by October to replace those leaving.

Outside advisers say frustration with the FDA culture is a major reason its turnover rate is twice that of other agencies.

Staffers who disagree with management reportedly are discouraged from speaking up, according to an Institute of Medicine report on the FDA’s drug safety system.

Staffers say strict deadlines for the review of drugs also contribute to stress.

“People are under enormous pressure to meet those review dates and they get burned out,” said Dr. David Ross, a former FDA drug reviewer who now teaches at George Washington University’s medical school.

Dr. Ross left the FDA in 2006 after a dispute with agency management over the safety of an antibiotic.

FDA’s outside advisers point the blame for staffing problems toward the White House and Congress, which have heaped new responsibilities on the agency without increasing its funding.

In the past 15 years, the FDA has received more than 100 new assignments, but the number of government-provided staffers has fallen from roughly 9,000 to 8,000. The result is less regulation even as the industries the FDA oversees grow larger.

The image of an overburdened agency has not made things easier for FDA recruiters, who are crisscrossing the country seeking applicants with science backgrounds.

At the center of the staffing effort is a proposed fellowship program that would bring 2,000 scientists and doctors into the agency every two years, with the goal of persuading some to stay.

But with no funding set aside for the program, even those pulling for the FDA are skeptical.

“It’s very unrealistic,” said Gail Cassell, a researcher at Eli Lilly & Co. who sits on the FDA’s science board. The group, which includes outside researchers from industry and academia, advises the FDA on science and research issues.

“Both in terms of attracting the best minds and being able to provide them with financial support, it would be very challenging,” she said.

The average medical student graduates with about $130,000 in debt, making a government fellowship financially daunting.

The FDA also faces tough competition from more traditional, and better paying, careers for science and medical graduates.

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