The House of Representatives passed the Food and Drug Amendments of 2022 (FDA22, H.R. 7667) on June 8 by a bipartisan vote of 392-28. The bill was approved by the House Energy and Commerce Committee on May 18 by a vote of 55-0 [refer to Washington Highlights, May 20]. The legislation would reauthorize the Food and Drug Administration’s (FDA’s) agreements to collect user fees from prescription drug, generic drug, biosimilar, and medical device developers.
The House-passed bill also includes provisions aimed at diversifying participation in clinical trials including premarket reporting of diversity action plans for trial sponsors, support for decentralized clinical trials and continuation of flexibilities adopted during COVID-19, improving outreach to underserved patients and providers, and incentivizing financial support from trial sponsors for participation in trials.
The AAMC joined nearly 75 stakeholder organizations in a June 8 letter to Senate Health, Education, Labor, and Pensions (HELP) Committee leaders urging inclusion of the clinical trials diversity provisions from the House-passed bill in the Senate’s user fee package. “As America becomes more racially and ethnically diverse, a clinical trial system that fails to enroll patients from growing demographics will not support the pace of innovation that will help us meet the needs of patients with chronic and acute health needs,” the letter stated.
Following passage, House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) and health subcommittee chair Anna Eshoo (D-Calif.) issued a press statement applauding passage of the FDA22. “The Food and Drug Amendments of 2022 will provide FDA with the funding it needs to carry out its mission of ensuring the safety and efficacy of prescription drugs and medical devices. The legislation will also … make sure clinical trials reflect the diversity of the patient population.”
Energy and Commerce Committee Ranking Member Cathy McMorris Rodgers (R-Wash.) and health subcommittee ranking member Brett Guthrie (R-Ky.) issued their own statement highlighting the chambers’ bipartisan efforts. “We thank all our colleagues for their bipartisan work from first subcommittee hearings in Energy and Commerce to today’s passage on the floor. We look forward to working closely with the Senate so these agreements are sent to the President’s desk on time.”
The HELP Committee introduced its FDA user fee proposal, the FDA Safety and Landmark Advancements (FDASLA) Act of 2022 (H.R. 4348), on May 26. While the Senate bill does not include provisions related to clinical trials diversity, it does include legislation to establish new regulations for laboratory-developed tests (LDTs). The AAMC expressed concern to the committee in a June 2 letter regarding the impacts to academic medicine and patient care if the proposed LDT regulatory text is passed in its current form [refer to Washington Highlights, June 3].
The HELP Committee was originally scheduled to mark up the FDASLA on June 8, but postponed the convening until June 14. New user fee agreements are considered must-pass legislation for Congress in advance of the Sept. 30 expiration of the existing agreements. Both chambers must agree to and pass the same legislative text before it can be signed into law.