The House bill on FDA amendments that passed, sponsored by Rep. Ann Eshoo (D-California), drew from the MDUFA V agreement between the FDA and medical device industry. It reauthorized the FDA user fee programs for prescription drugs, medical devices, generic drugs and biosimilar through the fiscal year 2027. It also required the development of action plans and related reporting to increase the diversity of participants in clinical trials.
“We appreciate the bipartisan work of the House of Representatives in advancing this important reauthorization,” AdvaMed CEO Scott Whitaker said in a news release. “Medical technology developers and manufacturers depend on timely FDA consideration of devices to serve patients. The MDUFA V agreement includes firsts for greater accountability, predictability, consistency, and communication to increase patient access to safe, effective medical innovations.”
Other provisions in the House bill included:
- Requiring the FDA to inform generic drug applicants upon request or during the review whether a drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why);
- Establishing requirements and reauthorizing programs to support the development of specific categories of drugs and devices, such as in the pediatric space, and inspections of drug manufacturing facilities;
- Requirements for post-approval studies and guidance about using real-world evidence to support drug and device applications.
The Senate Health, Education, Labor and Pensions Committee is working on its own version of the legislation, which also contains the core agreement. The goal is to get the legislation to President Biden’s desk by the end of September, when the present user fees framework expires.