Legislators reached a tentative deal Friday to reauthorize the FDA's authority to collect user fees, extending funding to maintain and streamline the agency's product approval process.
The bipartisan leaders of the Senate's and U.S. House of Representatives' health committees released a draft of the bipartisan Food and Drug Administration Reauthorization Act Friday. The act would reauthorize the FDA's four user fee agreements that renew the FDA's authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, and several crucial programs at the FDA. The fees would incrementally increase year over year.
The agency would have to layoff more than 5,000 employees if the agreements are not reauthorized before the end of September. A reauthorization delay also would postpone the review of many drugs and devices.
In his proposed 2018 budget, President Donald Trump planned to double the $1 billion in revenue the fees generate — the reauthorization is pivotal to Trump's promised reform of the agency and its "slow and burdensome" approval process, he said.
"If we do not move quickly to reauthorize these agreements, in late July, the FDA will be forced to begin sending layoff notices to more than 5,000 employees to notify them that they may lose their job in 60 days," said U.S. Sen. Lamar Alexander (R-Tenn.) in a news release issued by the House Energy and Commerce health subcommittee. "The sooner we reauthorize the agreements, the better — to give patients, reviewers and companies certainty."
Supporters of the act said that it would be a boon for the device industry. Critics argued that a fee hike would hurt smaller companies.
The user fee programs accounted for 70% of the brand drug review budget, 36% of the medical device review budget, 75% of the generic drug review budget, and 29% of the biosimilar review budget for fiscal year 2016.
"These carefully negotiated agreements encourage innovation, improve our regulatory review process, and provide certainty to both patients and industry," U.S. Rep. Frank Pallone, Jr. (D-N.J.) said.