FDA User Fee Legislation Advances in Senate

A broad bill carrying multiple proposals for revising and expanding FDA programs and policies, in addition to reauthorizing user fees critical for funding FDA operations, was endorsed by the Senate Health, Education, Labor and Pensions (HELP) Committee this week. The legislators approval of the FDA Safety and Landmark Amendments (FDASLA) by a 13-9 committee vote sets the stage for full Senate reauthorization of industry fees to support oversight and development of prescription drugs, generic drugs, biosimilars, and medical devices.

The measure adopts a host of new programs and requirements that stand to make significant changes in how FDA regulates a range of medical and food products. However, many of the specific additions and revisions in the Senate bill differ from legislation already passed by the House as the FDA Amendments of 2022 (HR 7667).¹ The situation requires the legislators to reconcile the two measures in order to enact final legislation by the current target of Aug 1.

The extensive Senate HELP bill builds on a discussion draft and updated package backed by HELP committee chair Patty Murray (D-WA) and ranking Republican Richard Burr (R-NC).² An important provision backed by Murray clarifies the pathway for importation of drugs from Canada, expanding the range of eligible products. Murray also endorsed new proposals for strengthening FDA oversight of cosmetics and dietary supplements, which establish a broad range of new requirements and regulatory processes for these products. In addition, the VALID (Verifying Accurate Leading-edge IVCT Development) Act backed by Burr updates FDA policies for authorizing in vitro diagnostics, with an eye to enhancing the agency’s ability to evaluate effective lab tests in public health crises.

Moreover, the legislators moved to address the current infant formula crisis by establishing an Office of Critical Foods in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). It provides a premarket review process for manufacturers of infant formula and requires FDA notification of production disruptions and recalls and switches to appropriate substitutions. A number of FDA reports to Congress on the program are included, along with revised procedures for FDA’s mailroom operations to prevent the loss of whistleblower reports and other important documents related to these and other regulated products.

Additional sections of the bill offer a range of enhancements for testing and marketing drugs and medical products. The development of treatments for rare diseases gains support from a new pilot program and other provisions. Competition from generic drugs may be enhanced by authorization of labels with certain differences from brands, while import is permitted for certain medical devices made overseas. FDA’s accelerated approval pathway is updated to ensure its support for innovative cardiology and neurology therapies, as well as cancer treatments. Added provisions aim to discourage the use of animal tests in developing drugs, cosmetics and other products. And FDA is required to move forward with policies to authorize over-the-counter hearing aids.

Important to FDA officials are provisions designed to expedite and simplify agency hiring practices and its ability to retain talented scientists and medical personnel. At the same time, the legislators extend oversight for FDA’s IT modernization program, requiring reports and clear goals and priorities to ensure that the added funds requested for this agency-wide initiative are effective and well-spent.

The wide scope of the legislation is not surprising, given the long history of policymakers adding multiple pet initiatives to this must-pass measure. As fees from regulated companies have become a main source of support for FDA oversight of the testing and development of critical medical products, the challenge remains to continue this financial support for the agency without enacting measures that will overload or undermine FDA and industry operations.

References

1. https://www.congress.gov/117/bills/hr7667/BILLS-117hr7667eh.pdf
2. https://www.help.senate.gov/imo/media/doc/FDASLA%20manager's%20amendment%20SXS.pdf