The House on Wednesday passed by voice vote a bill (HR 2430) that would reauthorize FDA user fees collected from drug and device makers.
The bill would reauthorize FDA's four user-fee agreements, which are set to expire at the end of September, that give the agency 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 and generic drug reviews.
The measure proposes increasing 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 would increase incrementally each year through FY 2022.
The bill contains several new amendments that bring the House's version more in line with a version pending in the Senate (S 934), which the Senate Health, Education, Labor, & Pensions Committee (HELP) approved in May. Those amendments include:
- Allowing hearing aids to be sold over the counter;
- Creating a pilot project to evaluate the post-market safety of medical devices;
- Easing requirements for medical imaging devices;
- Encouraging drug and device developers to develop and test new pediatric oncology treatments; and
- Offering a six-month exclusive rights period for first-time generics entering a limited market in an effort to increase generic drug competition.
In addition, one amendment would change the reporting process for medical device malfunctions. Currently, medical device makers submit malfunction reports for their products within 30 days of the problem surfacing. Under the amendment, medical device makers would need to submit only one report every three months detailing known problems with their products. This amendment has sparked some criticism from consumer and provider advocates, who say it could slow reporting.
Scott Whitaker—president and chief executive of the medical device trade group AdvaMed, which supports the House bill—in a statement said, "All of our companies report adverse events quickly and as clearly as they can," adding, "It's in our interest to do it. We want safe, effective products more than anyone else." Greg Crist, a spokesperson for AdvaMed also noted that the relaxed reporting rules would not apply to devices that have been on the market for less than two years.
The bill now goes to the Senate, which has yet to vote as a full body on its own version of the user fee bill. According to CQ HealthBeat, the Senate plans to take up the user fee bill after GOP lawmakers come to an agreement on a final health care reform bill—though it remains to be seen whether they will move forward with the House version of the FDA bill or the Senate HELP committee's bill, which would then need to be reconciled with the House before being sent to the president.
Senate HELP Committee Chair Lamar Alexander (R-Tenn.), a primary sponsor of the Senate bill, said, "We think the House bill is a very good bill, almost the same as the Senate bill, so it'll give [Senate Majority Leader Mitch McConnell (R-Ky.)] two different options for trying to do the bill before the August recess" (Kacik, Modern Healthcare, 7/12; Siddons, CQ HealthBeat, 7/12 [subscription required]; Kaplan, New York Times, 7/11).
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