U.S. House of Representatives passes FDA user-fee bill

The U.S. House of Representatives cleared a bill on July 12 that reauthorizes the Food & Drug Administration to collect fees from companies to pay for reviews of new drugs and medical devices through fiscal 2022. The legislation now awaits a vote by the Senate, which is expected to pass it before lawmakers go on recess in August.

H.R. 2430 represents months of negotiations among FDA, the medical products industry, and Congress. The bipartisan bill aims to provide FDA with resources to bring new drugs and medical devices to market faster. It also contains provisions to improve FDA’s drug review process, including increasing the use of drug development tools such as biomarkers.

FDA typically receives about $2 billion each year from industry to help pay for safety and efficacy reviews of new pharmaceuticals and medical devices. That figure would stay about the same under H.R. 2430, providing FDA with nearly 60% of the money it spends on reviewing drugs and medical devices.

The White House, however, objects to the current level of industry-paid fees and is urging Congress to instead require companies to pay 100% of the costs of FDA’s premarket reviews. “In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it,” the Trump Administration says in a statement.

Experts predict that getting lawmakers to agree to the Administration’s request at this stage in the process is unlikely, given that FDA’s current user-fee authority expires Sept. 30.