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Apr 28, 2008
 |  BioCentury  |  Regulation

Expect some delays II

Regulation

Expect some delays II

FDA last week received direct hiring authority for a number of key jobs essential to the review and oversight of new drugs. But while the move will help the agency fill vacant slots in the Office of New Drugs (OND) and other parts of the agency more quickly, it will take FDA years to absorb and train new employees, and new safety mandates imposed by Congress will continue to compete for resources with the agency's PDUFA objectives.

The new authority, granted by the Office of Personnel Management, will enable FDA to bypass some of the bureaucratic maze at a centralized HHS personnel office that has bedeviled its efforts to fill hundreds of positions that are funded by increased industry user fees approved by Congress last year.

The dysfunctional hiring system, which can take 3-6 months or longer to vet and approve an applicant, combined with pressure to ramp up new pre- and post-market safety systems, led FDA in January to give drug review division managers discretion to miss PDUFA deadlines (see BioCentury, March 3).

The new ability to hire candidates directly, rather than depend on HHS, should cut several weeks off the timeline from identifying a potential employee to making a job offer, OND Director John Jenkins told BioCentury last week.

Nevertheless, he said that recruiting and retaining staff needed to ensure adherence to PDUFA deadlines and implement new safety initiatives would remain a challenge as FDA competes with life sciences companies for a limited pool of qualified individuals.

Even after OND has filled most of its 130 open positions, it will take up two or three years to absorb and train the bolus of new hires, some of whom will need to be replaced as they are recruited by companies hungry for hands-on regulatory experience.

There are also hundreds of vacancies in other parts of FDA, and in the wake of headlines about heparin contamination, Congress is considering enacting legislation that would expand the number of investigators and inspectors.

At the same time, FDA and industry will be treading new ground as they implement requirements for risk evaluation and mitigation strategies (REMS) and other provisions in the FDA Amendments Act (FDAAA). These could, at least in the short term, lead to missed PDUFA deadlines and extra review cycles that...

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