FDA Brain Drain Harms Drug Approvals, Food Inspections

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 FDA's most experienced scientists, they leave an increasingly leaner, less confident staff that is hesitant 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 has repeatedly 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-person work force reaches 54. Thirty percent of the agency's regular staff are already eligible to retire and FDA expects to hire 600 staffers by October to replace those leaving.

FDA's outside advisers say frustration with FDA culture is a major reason its turnover rate is twice that of other agencies.

Staffers who disagree with management are reportedly discouraged from speaking up, according to an Institutes of Medicine report on 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 David Ross, a former FDA drug reviewer who now teaches at George Washington University's medical school.

Ross left 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 last 15 years, 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 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 convincing some to stay on.

But with no funding set aside for the program, even those pulling for 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 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."

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.

"If you look at the 20,000 medical students graduating each year, only a very small portion would even be interested in a career that leads to a government agency," said Michael Ehlert, president of the American Medical Student Association.

The danger of dwindling inspections hit home earlier this year when FDA said contaminated heparin from Baxter International Inc. was associated with as many as 81 deaths and hundreds of allergic reactions.

FDA didn't inspect the Chinese plant where the blood thinner was produced due to a bureaucratic mix-up involving a factory with a similar name.

While FDA records list 3,249 foreign drug manufacturers subject to inspections, it can't tell if it has inspected two thirds of them, according to Government Accountability Office investigators.

The agency may soon get an injection of much-needed funds.

After weathering nearly weekly scoldings from lawmakers, FDA Commissioner Andrew von Eschenbach asked Congress last month for an emergency $275 million to supplement this year's $2.3 billion fiscal budget.

Agency heads, who are appointed by the White House, almost never break ranks with the president's recommended budget. But given FDA's compromised position, "everyone has come to the realization that without significant added resources, the agency will not be able to continue to fulfill its mission," Cassell said.

The Senate subcommittee that oversees FDA's budget passed a bill to deliver the additional funding later in the month.