House Shows Bipartisan Support for Amending FDA User Fee Agreements
U.S. House of Representatives’ Energy and Commerce Committee
Chair Frank Pallone, Jr. (D-N.J.), Ranking Member Cathy McMorris Rodgers (R-Wash.),
Health Subcommittee Chair Anna G. Eshoo (D-Calif.), and Health Subcommittee Ranking
Member Brett Guthrie (R-Ky.) introduced the “Food and Drug Amendments of 2022” on May 4. This legislative
package would reauthorize the U.S. Food and Drug Administration (FDA) user fee agreements.
FDA user fee agreements allow the agency to collect fees from
drug manufacturers to fund the new drug approval process. To continue collecting
user fees, FDA is required to meet certain performance benchmarks related to the
speed of certain activities within the new drug approval review process. Specifically,
the legislative package reauthorizes the Prescription Drug User Fee Act, Generic
Drug User Fee Act, Biosimilar User Fee Act and Medical Device User Fee Act.
The Health Subcommittee is slated to mark up the bill this week. This is one of
the few bills jointly introduced by both the Democratic chairs and the Republican
ranking members on the Energy and Commerce Committee.
The newly introduced legislation includes provisions from H.R. 6963 Accelerated Approval Integrity Act of 2022, which was
introduced earlier this year by U.S. Rep. Pallone. This bill requires the accelerated
approval of drugs to automatically expire after a certain time period for companies
that haven’t met post-market clinical benefit requirements. This would ensure
that drugs that receive accelerated approval are providing a proven clinical benefit to patients.
The Accelerated Drug Approval Program allows patients to
access innovative new drugs while the manufacturer and FDA conduct additional
studies to confirm the product’s clinical benefit. However, a British Medical
Journal investigation found that half the drugs approved under accelerated
approval never had a confirmatory trial done. Though they were unsuccessful, the
pharmaceutical industry fought hard to prevent the inclusion of provisions from
H.R. 6963 in the reauthorization of FDA user fee agreements.
