President Trump on Friday signed into law a bill (HR 2430) that reauthorizes FDA's user fee agreements.
The bill, called the FDA Reauthorization Act of 2017, reauthorizes FDA's four user-fee agreements, which were set to expire at the end of September. The agreements give FDA the authority to collect fees from medical device and drug companies to help pay for product reviews. The fees account for a majority of FDA's budget for both brand-name and generic drug reviews.
The measure increases the user fees paid by medical device and drug companies by $400 million in fiscal year (FY) 2018 to increase staffing at the agency and accelerate product approvals. User fees will increase incrementally each year through FY 2022.
The bill also:
- Allows hearing aids to be sold over the counter;
- Creates a pilot project to evaluate the post-market safety of medical devices;
- Eases requirements for medical imaging devices;
- Encourages drug and device developers to develop and test new pediatric oncology treatments; and
- Offers a six-month exclusive rights period for first-time generics entering a limited market in an effort to increase generic drug competition.
In addition, the legislation changes the reporting process for medical device malfunctions. Previously, medical device makers submitted malfunction reports for their products within 30 days of the problem surfacing. Under the new law, medical device makers now need to submit only one report every three months detailing known problems with their products (Diamond, "Pulse," Politico, 8/21; King, Washington Examiner, 8/18).
5 things your docs may not know about supply costs
Your physicians know all about clinical supply performance and how product selection drives patient outcomes—but they may not know how supply sourcing and pricing can hurt the hospital’s financial performance.
To help you align your physicians around supply cost management, we compiled a list of the five knowledge gaps you should address.