House Approves FDA User Fee Reauthorization

The U.S. House of Representatives overwhelmingly passed legislation to reauthorize and expand the U.S. Food and Drug Administration’s (FDA) user-fee programs.

The program allows the FDA to collect fees from the drug and medical device sectors in exchange for meeting certain performance goals related to timely consideration of their product marketing applications. Federal law requires reauthorization of the user-fee program every five years.

Approved by a 387-5 vote, the bill sets forth several policy reforms pertaining to drugs and medical devices. The legislation will increase user fees drug and medical device companies pay to the FDA and should expedite the review process for these devices and improve transparency of their clearance process. Lawmakers are expected to have a final draft of the legislation by early July. The change to the bill would reduce the federal deficit by $340 million over 10 years rather than add $247 million to the deficit, according to the Congressional Budget Office.

The Senate passed its version of the FDA user-fee reauthorization on May 24. The two chambers must now reconcile differences and pass common legislation.

Overall, the two bills largely are similar but have differences that are important to their sponsors. For example, both bills include measures that require drug manufacturers to notify the U.S. Health and Human Services secretary at least six months before a drug is discontinued. But while the Senate bill included a provision that requires the secretary to create a task force to improve the agency’s response to shortages and draft a plan to improve interagency coordination, the House bill did not.

The FDA’s current user-fee program is set to expire at the end of September.

“AdvaMed is pleased with the continued bipartisan support of this key piece of legislation. The strong support of the measure, similar to its passage in the Senate, underscores its importance and benefits to American patients, the FDA and the medical technology industry,” said Steve Ubl, president and CEO of the device industry’s largest trade group. “This potentially game-changing user fee agreement includes provisions that will strengthen accountability measures provide additional FDA resources. And under the agreement, the FDA is presented with an opportunity to improve its predictability, consistency and efficiency, while continuing to adhere to its high standard for product approval.

Ubl added: “We extend our appreciation to House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Reps. Henry Waxman (D-Calif.), Joseph Pitts (R-Pa.) and Frank Pallone (D-N.J.) for their leadership in the progression of this legislation.