The FDA and device companies, through three trade associations, came to an agreement that will increase the user fees paid to the FDA to nearly $1 billion, according to a Politico report.
Here are five key notes:
1. A draft deal announced Monday has device companies paying nearly $1 billion in FDA fees from 2018 to 2022, a 68 percent increase from the current $595 million paid in a deal brokered in 2012.
2. The increased fee will allow the FDA to hire additional reviewers and fund IT and infrastructure improvements.
3. The agreement should reduce total review time for devices. New requirements stipulate two independent analyses of how the FDA managements the review process. The FDA will also have enhanced reporting requirements.
4. The FDA committed to provide company feedback five days before meetings on forthcoming applications. They will also undergo a pilot project to test the way real world evidence could be used to support pre-market activities.
5. The increased user fee for medical devices is expected to be bundled with increased user fees for branded drugs; the FDA is still finalizing negotiations with biologic and generic drug makers, according to the report.
6. The current agreements on user fees expire in October 2017.