FDA Policy/General

Senate HELP Committee Passes FDA User Fee Bill

David McFarland

— 2 min read
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The Senate Health, Education, Labor and Pensions Committee late 6/14 passed in a 13 to 9 vote the FDA Safety and Landmark Advancements (FDASLA) Act, which reauthorizes the agency’s prescription drug, generic drug, biosimilar, and medical device user fee agreements for another five years beginning 10/1. The measure includes a number of non-user fee-related provisions, including one described by the committee leadership as a “bipartisan deal” to establish safe drug importation from Canada to lower drug costs for families. The bill now heads to the Senate floor for a full vote by the chamber.

 

Committee chair Patty Murray (D-WA) said the provision she spearheaded in negotiations with Republicans would “establish safe drug importation from Canada by:

  • removing barriers that have prevented personal importation in the past and paving the way for FDA to establish a program for importation of prescription drugs for personal use—while ensuring the drugs are the same safe and effective drugs available domestically;
  • building on work FDA has begun to expand commercial importation of less costly prescription drugs from Canada by states, Indian tribes, and other groups;
  • and giving FDA the tools it needs to quickly address any importation program that poses a risk to public health and safety.”

The drug importation provision is Section 906 of FDASLA, and a section-by-section of the bill is here, and the legislative text here.

 

Unlike the House bill, which recently passed a floor vote, the Senate version contains a provision on regulating in vitro diagnostic tests (see earlier story). The provision, Verifying Accurate Leading-edge IVCT Development Act of 2022, defines regulations for the tests and 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.

 

Additionally, the Senate measure, like the House bill, looks to enhance the accelerated drug approval process. It clarifies that FDA may specify the conditions for a post-approval study, which may include enrollment targets, study protocol, milestones, and target date for study completion. It also clarifies that the agency may require post-approval 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.

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