BioCentury
ARTICLE | Politics, Policy & Law

Clean FDA user fee reauthorization teed up for 11th hour passage

Congress dropping diagnostics reform, abandoning tradition of bipartisan collaboration on FDA bills

September 23, 2022 10:52 PM UTC

Barring a last-minute surprise, Congress will reauthorize FDA user fees next week, days before they are set to expire, as part of a temporary spending bill. The vote will allow the agency to avoid notifying thousands of employees that their jobs are at risk, a threat it would have to act on if Congress failed in the coming weeks to give FDA authority to collect fees that industry has agreed to pay.

As a result of an intervention by Sen. Richard Burr (R-N.C.), the user fee bill will be “clean,” shorn of all or most of the policy provisions enacted in legislation passed by the House of Representatives and agreed to by the Senate Health, Education, Labor and Pensions (HELP) Committee. Burr, who insisted on a clean reauthorization, prevailed because Democrats cannot enact the legislation without substantial Republican support and Burr commands respect on FDA issues among his GOP colleagues...