User fees are paid by the device industry to fund the agency's review process; in exchange, the FDA agrees to certain performance goals. The user-fee programs must be reauthorized every five years.
The FDA missed a Jan. 15 deadline to submit the device user-fee recommendations to Congress although it provided lawmakers with recommendations for the reauthorization of the Prescription Drug User Fee Act and recommendations for proposed user-fee programs for generic drugs and biosimilars.
Earlier this month, the agency announced that it had reached an agreement in principle with the device industry, but had not yet finalized the fee structure or the recommendations.
Shuren said the proposed agreement will be submitted to Congress in mid-March. Shuren also told Rep. John Dingell (D-Mich.) that he supported a performance goal that would require the FDA to hire an independent consulting firm to analyze the agency's management of device-review processes.
Rep. Bill Cassidy (R-La.), a physician, noted that the FDA received an increase in revenue and staff during the last reauthorization of the Medical Device User Fee and Modernization Act, but approval times for devices still increased. Shuren attributed the increase in approval times to “program issues” that were separate from resources within the department as well as an insufficient increase in the resources that FDA received.
“The resources we got weren't sufficient for the work we had to do,” Shuren said.