User Fees and Beyond

The FDA Safety and Innovation Act of 2012

This perspective examines the Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) of 2012. This bill addresses the need to reauthorize statutorily defined user fees that pharmaceutical and medical-device manufacturers pay when submitting applications to the FDA for product evaluation. The bill was seen as necessary, in part, due to the chronic underfunding of the FDA.

Key Findings:

  • FDASIA works to streamline premarketing review of drugs and devices, allowing the FDA to designate a new drug candidate as a “breakthrough therapy,” resulting in expedited development and review.
  • In an effort to improve performance targets for reviewing devices, by 2016, the FDA must issue decisions within 90 days for 95 percent of the devices following the 510(k) track used for most moderate-risk devices.
  • FDASIA directs the FDA to develop a strategic framework for information technology regulation within 18 months. This allows the FDA to address mobile medical applications.
  • FDASIA will aim to streamline the approval process for generic drugs by increasing funding to the FDA’s generic-drug reviewers.

Despite these expansions, FDASIA misses the opportunity, according to the authors, to enhance post-marketing evaluation of drugs and devices, which validates effectiveness and ensures safety of marketed products.