FDA announces hiring spike; receives emergency funding for initiatives

Medical Product Outsourcing, June, 2008

The FDA is planning to significantly boost its employee base. Officials plan to hire 1,300 biologists, chemists, medical officers, mathematical statisticians and investigators within the next several months, the agency announced at the end of April. The announcement comes following a wave of hearings by lawmakers on Capitol Hill.

Consumer advocates and lawmakers have been blasting the agency for lax oversight. Congress also has been pressuring the FDA to improve its operations, strengthen its inspections and hire more experts.

"It takes a large pool of talented people for the FDA to protect and promote the public health," John Dyer, the agency's deputy commissioner for operations and chief operating officer, said in a press release. "Each month there is a delay in bringing critical staff on board impairs the agency's ability to fulfill this mission."

In fiscal year 2008, the FDA is looking to fill more than 600 new positions and to backfill more than 700 others to implement the FDA Amendments Act of 2007, the Food Protection Plan and the Import Safety Action Plan. That's nearly triple the number of people hired from 2005 to 2007. The goal is to accomplish this by October.

A panel of outside advisers recently said the FDA needs $375 million next year to start repairing its understaffed, outdated food, drug and device safety operations. The Senate recently passed a resolution supporting the increase.

At a Senate hearing on April 15, FDA Commissioner Andrew yon Eschenbach said the agency would be unable to allocate that increased funding in one year because of the time-consuming process of recruiting and training hundreds of new employees (see Top of the News in the May issue of MPO). Since early April, both houses in Congress have questioned the FDA's recent budget request for the 2009 fiscal year as being insufficient to meet staffing demands and product review requirements.

The FDA said it was granted special authority by the Office of Personnel Management to expedite the hiring, which is done when a severe shortage of candidates exists.

Weeks prior to the FDA hiring announcement, von Eschenbach had told a Senate panel: "We are on a trajectory to increased staff. We just have to push it off a little. 'The FDA's Office of Devices and Radiological Health, in particular, was cited by lawmakers as being at risk due to a significant reduction of key personnel as a result of retirements.

But how quickly things can change in Washington, DC.

Facing congressional demands, von Eschenbach sent a letter to Sen. Arlen Specter (R-PA) requesting a much-needed infusion of $275 million in additional funding for this fiscal year. Senate Democrats had been working on just such a proposal.

In his correspondence with Specter, yon Eschenbach estimated $125 million would be for food protection; $100 million for safer drugs, devices and biologics; and $40 million would go toward updating the FDA's science and workforce. The agency could use $10 million to update facilities and laboratories overseas.

The FDA chief cautioned, however, that the figures reflect his professional judgment and don't reflect "competing priorities that the agency, the president and their advisors must consider as budget submissions to the Congress are developed."

On May 15, the Senate Appropriations Agriculture Subcommittee voted to include the additional funds as part of FY 2008 emergency supplemental appropriations bill, which also provides $275 million for international food aid programs and the wars in Iraq and Afghanistan. The move was approved by the Senate Appropriations Committee.

The boost in FDA funding is in addition to the increase of nearly $150 million provided during the FY 2008 Agriculture Appropriations bill, bringing the total FDA funding increase for this year to nearly $425 million.

According to the office of Sen. Herb Kohl (D-WI), chairman of the Senate Appropriations Agriculture Subcommittee, the additional funds would allow the FDA to hire an additional 119 food safety inspectors and 99 medical product safety inspectors, conduct 120 more foreign medical product facility inspections, 575 more domestic medical product inspections and 10,000 additional medical product import exams, in addition to expanding training and databases to improve risk-based prevention.

Industry groups were quick to applaud the effort.

"AdvaMed commends the Senate Appropriations Committee for providing FDA with additional funds which will help the agency continue its crucial mission of protecting and promoting the public health, 'said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association. "FDA has the vital responsibility to ensure the safety and effectiveness of America's medical technology products, and these additional resources will help it continue to meet its public health mandate. We look forward to working with the members of both the House and Senate to ensure that these needed resources for FDA are quickly made available."