House Passes FDA Package Reauthorizing Drug, Device User Fees

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The House on Wednesday passed a sweeping package of measures to reauthorize fees that help fund the FDA as the Senate struggles to pass its own version of the bipartisan legislation.

House members voted 392 to 28 under suspending the rules to pass the legislation (HR 7667). The measure would set a base amount of $1.15 billion for human prescription drug makers for fiscal year 2023 and revamp the FDA’s fast-track approval pathway that has come under renewed scrutiny after Biogene Inc.Approval of drugs for Alzheimer’s disease. It also includes provisions to improve diversity in clinical trials.

The vote marks a crucial step in reauthorizing user fees the Food and Drug Administration receives from the drug and medical device industries for fiscal years 2023 through 2027. The current authorization is set to expire Sept. 30, and lawmakers said that they wanted to see a new package finalized before the August holidays.

Suspending House rules is often used to quickly pass largely uncontroversial legislation. FDA user fees represent about half of the total FDA budget and are considered mandatory legislation.

The House package contains several provisions, including one on pediatric cancer research, that are not in the version before the Senate. House and Senate leaders have not announced plans for how they will reconcile the differences between the two versions.

The House measure would give the FDA the power to pull any drug that has won fast-track approval from the market if it fails to show clinical benefit. The FDA and lawmakers have both pushed for legislative changes to minimize the time between when a drug enters the market and the completion of studies showing clinical benefit.

The legislation would also allow the FDA to require drug and device companies to submit diversity action plans for their clinical trials.

Also included are provisions to speed up generic drug approvals, including letting the agency approve a generic drug even if the branded version’s label changes during the review process. Lawmakers have accused drug companies of doing this to delay market entry of cheaper alternatives.

Rep. Anna Eshoo (D-Calif.), chair of the House Energy and Commerce Health Subcommittee, introduced the bill May 6. The Energy and Commerce Committee voted 55-0 to move it forward on May 18.

Differences between the House and the Senate

The Senate Health Committee is scheduled for June 14 to annotate its own version of the user fee package.

Some of the provisions of the House were not included in the Sens proposal. Patty Murray (D-Wash.) and Richard Burr (RN.C.), chairman and ranking member of the Senate Health, Education, Labor and Pensions Committee.

Language based on a childhood cancer research bill called the Give Kids a Chance Act (HR 6972) is not in the current Senate package. The bill, which was added as an amendment to the House package during the May 18 markup, would authorize the FDA to require companies investigating a combination drug for adult cancer that they launch also a pediatric study plan if there are molecular similarities.

The Senate version also does not include provisions on the diversity of clinical trials. It contains additional proposals not found in the House version to require dietary supplement and cosmetic makers to register their products with the FDA.

Unlike the House package, the Senate proposal would revamp how the FDA regulates diagnostic tests and allow the FDA to require opioids be dispensed to patients with safe home disposal systems.

The Senate HELP committee has yet to release a final package for next week’s scoping session as lawmakers are still working on possible policy amendments. Sen. Bernie Sanders (I-Vt.) told Bloomberg Law on Wednesday that he would propose an amendment to the FDA’s user fee bill allowing the importation of prescription drugs.

“Our goal is to do what the American people want, to dramatically reduce the price, the exorbitant prices of prescription drugs in America,” he said.

—With help from Alex Ruoff


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