FDA user fee clears House; Senate must act before October
With the clock ticking, the House of Representatives last week took a major step toward reauthorizing the Food and Drug Administration’s ability to collect user fees from drug and device makers and avoid having to hand out pink slips to thousands of agency staffers.
The House approved a bill calling for more than $400 million in new user fees in fiscal 2018, with incremental increases each year thereafter. It would allow the FDA to hire more staffers and speed up approval of drugs and devices, which could help healthcare companies streamline operations, supporters argue.
Yet, critics claim that the rising fees disproportionately affect smaller companies and that expediting the review of drugs and medical devices could compromise quality.
The bill includes an amendment providing a six-month exclusive rights period to any generic manufacturer choosing to compete against an off-patent drug that has no competition. Currently, that exclusivity is available only to a first entrant. Other provisions include easing requirements for medical imaging devices, creating a pilot project to evaluate the post-market safety of medical devices, forming a new regulatory class of hearing aids that could be sold over the counter and adjusting the risk-based classification of medical devices in an effort to improve the predictability of review periods.
The user-fee program must be reauthorized by the end of September or the FDA will have to lay off more than 5,000 employees. A delay also would postpone the review of many drugs and devices.
The Senate Health, Education, Labor and Pensions Committee approved its version of a bill in May, but the full Senate has yet to take action, and the window is closing given an already packed agenda that includes repealing and replacing the Affordable Care Act, addressing the debt ceiling and passing a budget. House and Senate versions of the bill have to reconciled before being sent to the president.