The United States Food and Drug Administration (FDA) gets much of its funding from the user fees it charges. These fees are used to fund the drug and medical device approval process before new drugs or medical devices come on the market.
Every five years, Congress must reauthorize these fees based on the previous two years of negotiations that take place before the reauthorization is voted on. The FDARA includes:
- Generic Drug User Fee Amendments
- The Biosimilar User Fee Act
- The Prescription Drug User Fee Act
- Medical Device User Fee Amendments
On Friday, August 18, 2017, President Trump signed the 2017 FDARA that reauthorized the FDA’s user fee agreements for drugs and medical devices and other new features for the FDA.
- The present user fee agreements expire in September. Had the reauthorization not passed, the FDA would have had to lay off employees. This new FDARA won’t expire until 2022. User fees contribute between $80 and $90 billion over a five-year period to the FDA budget for
- One of the most notable features of the 2017 FDARA is the authorization of the Medical Device User Fee Agreement (MDFUA) that codifies some new approaches to digital health. It establishes a central digital health unit within the Center for Devices and Radiological Health (CDRH). The FDA had already begun recruiting for central digital health unit before the passage of the bill.
- Another feature of this bill is the fast-tracking of generic competitor approvals, This could lead to a cost-savings for Medicare expenses related to generic drugs.
- Another benefit of this legislation is a new provision in the act allowing for faster collection of real-time clinical use data from patients in early development and marketing instead of relying only on clinical trial results.
The bill passed the house and the senate with little opposition and the President signed it without a ceremony.