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House Passes FDA Package Reauthorizing Drug, Device User Fees

June 9, 2022, 12:31 AM

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

House members voted 392-28 under suspension of the rules to pass the legislation (H.R. 7667). The measure would set a $1.15 billion base fee amount for human prescription drugmakers for fiscal 2023, and revamp the FDA’s accelerated approval pathway that gained renewed scrutiny after Biogen Inc.‘s Alzheimer’s drug approval. It also includes provisions to improve diversity in clinical trials.

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

Suspension of House rules is often used to quickly pass largely uncontroversial legislation. FDA user fees make up roughly half of the FDA’s total budget, and are considered must-pass legislation.

The House package contains several provisions, including one on pediatric cancer research, that aren’t in the version under consideration in the Senate. House and Senate leaders haven’t announced plans for how they will reconcile differences between the two versions.

The House measure would give the FDA the authority to remove from the market any drugs that obtained accelerated approval if they fail to show a clinical benefit. Both the FDA and lawmakers have pushed for legislative changes to minimize the amount of time between when a drug enters the market and studies demonstrating a clinical benefit are completed.

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 the approval of generic drugs, including by letting the agency approve a generic drug even if the brand-name version’s label changes during the review process. Lawmakers have accused pharmaceutical companies of doing this to delay the market entry of lower cost alternatives.

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

House, Senate Differences

The Senate health committee is scheduled June 14 to mark up its own version of the user fee package.

Some of the House’s provisions didn’t make it into the proposal by Sens. Patty Murray (D-Wash.) and Richard Burr (R-N.C.), the chair and the ranking member of the Senate Health, Education, Labor, and Pensions Committee.

Language based on a pediatric cancer research bill called the Give Kids a Chance Act (H.R. 6972) isn’t 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 drug combination for an adult cancer to also launch a pediatric study plan if there are molecular similarities.

The Senate version also doesn’t include provisions on clinical trial diversity. It does contain additional proposals not in the House version to require that dietary supplement and cosmetic makers 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 that opioids be dispensed to patients with safe, in-home disposal systems.

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

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

—With assistance from Alex Ruoff

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com