On March 21, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on Food and Drug Administration (FDA) user fee agreement reauthorizations. In the first of two expected hearings, senators discussed the ability of the user fee agreements to improve medical product regulation and advance initiatives laid out by the 21st Century Cures Act passed in the last Congress. On a broader level, there are four different user fees that are the subject of hearings and must be updated and reauthorized by Congress. This includes the prescription drug user fee act (PDUFA), the medical device user fee amendments (MDUFA), the generic drug user fee amendments (GDUFA), and the biosimilar user fee act (BsUFA).
Participants
At the hearing included FDA’s Janet Woodcock, Director for the Center for Drug Evaluation and Research; Peter Marks, Director of the Center for Biologics Evaluation and Research; and Jeffrey E. Shuren, Director of the Center for Devices and Radiological Health. Chairman Alexander announced a second hearing on user fees would be held April 4, during which patients, device manufacturers, and brand and generic drug manufacturers are expected to testify.
Selected Opening Statements
Chairman Lamar Alexander opened the hearing by thanking the committee for working together in the past to advance important legislation such as the 21st Century Cures Act. He asked that the Committee work together again to advance the reauthorization of user fee agreements “to ensure that the policies laid out in the 21stCentury Cures Act to support innovative medicines and therapies are not delayed by the drug approval pipeline.” […] The sooner we reauthorize the agreements, the better – to give patients, reviewers and companies certainty,” he said. Chairman Alexander also warned that any bills being added to user fee reauthorizations must be bipartisan and non-controversial to ensure the user fees are reauthorized before adverse effects are triggered. Patty Murray (D-WA) began by reminding Chairman Alexander of the letter sent to him and signed by every Democrat on the Committee asking that the hearing be delayed to instead discuss the healthcare bill currently moving through the House of Representatives.
Selected Testimony
Dr. Woodcock indicated that the FDA user fees are responsible for fast and predictable review of innovative therapies for Americans, and ensure these therapies are available first in the United States. She reminded the Committee that prescription drug user fees have brought many cures to the market recently. Dr. Marks stated the user fees fund the Center for Biologics Evaluation and Research have advanced necessary public health initiatives such a vaccine development, approval, and distribution. He spoke to the importance of the applications of biologics, and the ability of regenerative medicine to meet currently unmet medical needs. Dr. Jeffrey E. Shuren affirmed that the user fee programs are much different from the last time he testified before the Committee. He declared that the Center for Devices and Radiological Health has gone beyond their three commitments under the medical device user fee program, and now approve innovative technology in record time.
Discussion
During the hearing, many Democrats used their time to express their disapproval for the timing of the hearing, which they argued should have been delayed to make way for discussion on the AHCA. For example. Sen. Elizabeth Warren (D-MA) grew frustrated when witnesses refused to respond to her questions regarding President Trump’s budget proposal. The Senator questioned whether budget cuts to the FDA would make it harder for the agency to operate, to which witnesses responded they were not in any position to discuss budgetary matters.
The hearing also offered little discussion of President Trump’s proposal to double industry user fees to fully pay for premarket approvals. Although most senators were quick to praise the user fee program, Sen. Richard Burr (R-NC) grilled witnesses on how the funding earned from user fees was spent. He asked several questions that suggested user fee funds were misspent, and even asked the witness if they thought the fees should be returned to manufacturers if they do not believe their agreement with the FDA was fulfilled.
Sen. Susan Collins (R-ME) noted during the hearing she will seek to add a Risk Evaluation and Mitigation Strategy (REMS) bill to a user fee reauthorization during markup. She asserted that certain brand pharmaceutical abuse the REMS system by preventing generic competitors from gaining access to drug samples for studies. Dr. Woodcock noted that FDA has notified the Federal Trade Commission about 150 times that pharmaceutical companies are using REMS to delay generics, but said that FDA itself cannot force companies to give branded drugs to generic manufacturers for studies.