The Food and Drug Administration’s (FDA) user fee programs, which pay the salaries of agency staff who review drug and medical device applications, are set to expire on October 1, 2022. These include the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Amendments (MDUFA).
The House Energy and Commerce Committee (E&C) and Senate Health, Education, Labor and Pensions Committee (HELP) are the two committees of jurisdiction that have now missed two self-imposed deadlines for reauthorization. It looks likely that a “clean” user fee reauthorization will be included in the stop-gap spending bill that Congress is expected to pass by the end of the fiscal year, September 30. Reasons for not yet passing the critical user fee reauthorization include differences between the House and Senate legislation that have yet to be reconciled, and notably, HELP Ranking Member Richard Burr’s (R-NC) disapproval of several policy riders added to the HELP Committee’s bill during mark-up.
In May, the House passed the Food and Drug Amendments of 2022 (FDA22) by a vote of 392-28. This bipartisan bill was introduced by House E&C Health Subcommittee Chair Anna Eshoo (D-CA) and Ranking Member Brett Guthrie (R-KY). HELP advanced their version of the legislation, the FDA Safety and Landmark Advancements (FDASLA), by a vote of 13-9 in June. This legislation was introduced by Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC). Key differences between the two bills include:
- The House bill would expand the FDA’s inspection authorities domestically and abroad;
- The House bill would authorize $100 million annually through 2027 for the National Centers of Excellence in drug manufacturing;
- The House bill would require diversity action plans for clinical trials and would also require drug makers to conduct pediatric studies of adult cancer drugs;
- The House bill would create a manufacturing technology pilot program at the FDA;
- The Senate bill would require the FDA to publish justifications of accelerated approvals and would require baby formula makers to notify the FDA of supply disruptions within a week;
- The Senate bill would allow imports of prescription drugs from Canada; and
- The Senate bill would provide the FDA with additional oversight and regulatory requirements for cosmetics, dietary supplements, and clinical laboratory developed tests.
In mid-July, Ranking Member Burr introduced his own “clean” reauthorization bill, the Food and Drug Administration Simple Reauthorization Act, free of any policy riders. User fee reauthorization legislation has historically been used as a vehicle for additional policy riders, as it is considered a “must-pass bill”. However, Burr was conflicted about what he considered “anti-innovation policies,” which were adopted during the committee markup. Provisions he opposes in FDASLA include limiting orphan drug exclusivity to approved indications, allowing the FDA to share brand drug information with generic drug makers, and allowing the FDA to ban certain uses for medical devices.
FDA Commissioner Robert Califf previously announced that, should the user fees fail to be reauthorized by the deadline, there would be enough funds for at least a full month before he has to begin laying off FDA staff. Without reasonable assurance that a user fee reauthorization will get passed, the agency is required to issue 60-day pink slips giving notice to those employees that they will be laid off.