House Passes User Fee/FDA Amendments Bill
The U.S. House of Representatives last night (6/8) voted 392 to 28 to pass the Food and Drug Amendments of 2022, which would reauthorize FDA user fee programs for prescription drugs, generic drugs, biosimilars, and medical devices. The measure is also intended to modernize certain programs (see earlier story), such as enhancing post-approval studies for accelerated approval drugs, boosting FDA’s inspection authorities, and improving patient diversity in clinical studies, among others.
The House bill will eventually need to be reconciled with a slower moving Senate version. The Senate Health, Education, Labor and Pensions Committee is planning a 6/14 markup of its bill to reauthorize user fee, which has added provisions to strengthen the accelerated approval pathway, advance over-the-counter hearing aids, boost FDA inspections, and modernize diagnostic test regulation. The Senate bill is entitled the FDA Safety and Landmark Advancements Act.
One area where the two measures diverge is in vitro diagnostic tests — the Senate version contains a provision on regulating such tests (see earlier story) that was released last month in a discussion draft but the House bill is silent on this. The Senate’s Verifying Accurate Leading-edge IVCT Development Act of 2022 defines regulations for in vitro clinical tests. It provides details for the premarket, abbreviated premarket, and supplemental application review and approval process, and it outlines the information required in such submissions. It also establishes conditions for certain tests to qualify for an exemption from the premarket review process and other requirements under the provision.
Like the House bill, the Senate measure looks to enhance the accelerated drug approval process. It clarifies that FDA may specify the conditions for a postapproval study or study, which may include enrollment targets, study protocol, milestones, and target date for study completion. It also clarifies that the agency may require postapproval studies to be underway prior to approval. Additionally, the bill describes expedited procedures for withdrawing an accelerated approval drug, and it requires that sponsors of drugs approved under accelerated approval submit a postapproval study progress report every 180 days.
Regarding inspections, the Senate version calls for FDA recognition of foreign government inspections. It also requires FDA to include additional information in an annual report about the timing of inspections and regulatory and enforcement actions. And it requires the agency to include additional information in an annual report on FDA domestic/foreign inspections and recognition of foreign government inspections.