House bill passes FDA funding fees but conflicts with Senate bill

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House bill passes FDA funding fees but conflicts with Senate bill

INICIO/Políticas y legislación | Posted 15/07/2022 0 Post your comment

In the Unites States (US), the House of Representatives voted to pass legislation to reauthorize the fees that help fund the US Food and Drug Administration (FDA). However, there are some conflicts between the House and parallel Senate bill that need to be overcome before either can be passed.

On 8 June 2022, House members voted to pass a measure (H.R. 7667) that will set a US$1.15 billion base fee amount for human prescription drugmakers for the fiscal year of 2023. In addition, as part of the package, FDA’s accelerated approval pathway is set to be updated.

The current fee agreement is due to expire on 30 September 2022 and this new package is set to reauthorize the user fees FDA gets from the drug and medical device industries between 2023–2027. These FDA user fees make up approximately half of FDA’s budget.

H.R. 7667 and the parallel US Senate bill do have some substantial differences, for example, the House bill includes provisions for paediatric cancer research, to speed up the approval of generic drugs, and to improve diversity in clinical trials, which are not present in the Senate version.

The House measure is also set to give FDA the authority to remove any drugs from the market that obtained accelerated approval if they fail to show a clinical benefit. It will also allow the agency to require drug and device companies to submit diversity action plans for their clinical trials.

In contrast, the Senate proposal is set to revamp how FDA regulates diagnostic tests, and will require opioids to be dispensed with safe, in-home disposal systems.

For the parallel bills to be passed by President Biden, they must first become more confluent.

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