FDA to Offer Incentives for Rapid Completion of Expedited New Drug Review Process

FDA Introduces Bonus Program for Expedited Drug Reviews

Background: The Food and Drug Administration (FDA) has introduced a pilot bonus program aimed at incentivizing agency drug reviewers to complete their work ahead of schedule. The initiative is part of a broader effort by FDA Commissioner Marty Makary to streamline the review process and reduce timelines.

Key Details:

• The bonus program will offer quarterly payments to eligible employees starting in August 2024.
• Payments will be based on "weighted time savings" achieved by employees and their teams, as well as ratings-based "work quality and work complexity".
• The program is intended to recognize and reward staff who find ways to be more efficient in delivering high-quality work activities that benefit patients.

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Eligibility: Only FDA staff directly involved in drug reviews, such as reviewers and team leaders, are eligible for the bonus payments. Employees not directly involved in drug reviews, such as factory inspectors, are not eligible.

Challenges and Concerns:

• The program raises questions about how payments will be distributed across large teams of staffers who contribute to drug reviews.
• The pilot presents potential ethical dilemmas if FDA reviewers are seen as being rewarded for rushing steps needed to confirm drug safety and effectiveness.
• The program may negatively impact public perception of the FDA, which has often been viewed as too closely aligned with the drug companies it regulates.

Context: The FDA has faced criticism over its recent handling of vaccines, gene therapies, and other specialty treatments. The agency has also lost drug review staff to retirements and resignations following broader layoffs and buyouts across other parts of the agency.

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