The House of Representatives passed the 2022 Food and Drug Amendments (FDA22, HR 7667) on June 8 by a bipartisan vote of 392 to 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 Food and Drug Administration (FDA) agreements to collect user fees from developers of prescription drugs, generic drugs, biosimilars and medical devices.

The bill passed by the House also includes provisions to diversify clinical trial participation, including premarket notification of trial sponsor diversity action plans, support for decentralized clinical trials, and continued flexibilities adopted during COVID-19, improving outreach to underserved patients and providers, and encouraging financial support from trial sponsors for trial participation.

The AAMC joined nearly 75 stakeholder organizations in a June 8 letter to the leadership of the Senate Committee on Health, Education, Labor and Pensions (HELP) calling for the inclusion of provisions on Clinical Trials Diversity Bill passed the House in the Senate User Fee Package. “As America becomes increasingly racially and ethnically diverse, a clinical trial system that fails to recruit patients from a growing demographic will not keep up with the pace of innovation that will keep us going. will help meet the needs of patients with chronic and acute health needs,” the letter reads.

After the passage, House Energy and Commerce Committee Chair Frank Pallone (DN.J.) and Health Subcommittee Chair Anna Eshoo (D-Calif.) issued a press release applauding the passage of the FDA22. “The 2022 Food and Drug Amendments will provide the FDA with the funding it needs to carry out its mission to ensure the safety and effectiveness of prescription drugs and medical devices. The legislation will also ensure that 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 its own statement highlighting the chambers’ bipartisan efforts. “We thank all of our colleagues for their bipartisan work from the initial Energy and Commerce Subcommittee hearings to today’s passage on the floor. We look forward to working closely with the Senate to that these agreements be sent to the president’s office in time.

The HELP Committee presented its FDA user fee proposal, the FDA Safety and Landmark Advancements Act (FDASLA) of 2022 (HR 4348), May 26. Although the Senate bill does not include provisions relating to the diversity of clinical trials, 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 on academic medicine and patient care if the proposed LDT regulatory text is adopted in its current form. [refer to Washington Highlights, June 3].

The HELP committee was originally scheduled to mark the FDASLA on June 8, but postponed the convening until June 14. The new user fee agreements are seen as must-have legislation for Congress before the existing agreements expire on Sept. 30. Both houses must accept and pass the same piece of legislation before it can be enacted.