By Pete Evich, AAHP government relations
July 1, 2017
Bills (S 934, HR 2430) that would renew the Food and Drug Administration’s (FDA) ability to collect fees from the drug and medical device industries are expected to get their final votes in the House and Senate in July. The House may consider its bill the first week after the July Fourth recess.
Specifically, the House and Senate legislation would reauthorize the user fee system for the FDA’s approval of drugs, medical devices, generic drugs, and biosimilars. Under both bills, the FDA agrees to review most drug applications within 10 months or less in exchange for the industry funding.
User fees paid by the drug and medical device industries support the salaries of hundreds of FDA staff. Federal employee union contracts require the FDA to give employees 60 days’ notice if the government won’t have enough money to pay them. If a user fee bill isn’t ready to go by Aug. 1, the FDA must send out warnings of potential furloughs or layoffs. User fee watchers are still optimistic that layoffs will be averted in time. No one at the FDA or in Congress wants to be responsible for those pinks slips. For comparison, the last user fee reauthorization, which took place five years ago, passed both chambers in June and was signed into law on July 9.
Recognizing both the must-pass nature of the bill and the partisan climate in Congress right now, the committee and its staff managed to keep the bill fairly clean, adding fewer non-funding related provisions relative to some past user fee agreements (UFAs).
Separate legislation to reform the OTC monograph system, as well as establish an industry user fee for monograph approvals, is working its way through the legislative process. The Consumer Healthcare Products Association is hoping the OTC monograph reform and user fee measure will be able to hitch a ride on the larger UFA reauthorization package. Given that homeopathic products were specifically excluded from FDA’s OTC monograph process in 1972, AAHP has lobbied the Congressional sponsors of the OTC legislation to ensure homeopathic OTCs are not subject to the user fees imposed by this measure.