FDA: ‘reasonable expectation’ of user fee reauthorization

Congressional dithering on user fee reauthorization has brought FDA to the brink of disaster, but the agency and its allies on Capitol Hill believe a last-minute reprieve is likely.

FDA’s authority to collect user fees for prescription, generic and biosimilar drugs, along with medical devices — and to pay thousands of employees — expires Sept. 30. It has contractual obligations to notify the thousands of employees whose jobs are funded by user fees of impending layoffs. ...