Gottlieb pledges device, drug reviews will be on time post shutdown
- FDA Commissioner Scott Gottlieb told lawmakers Wednesday the agency plans to adhere to review timelines for medical devices and drugs agreed to in its user fee agreements despite the 35-day government shutdown's impact on the agency.
- Gottlieb told the House Appropriations Subcommittee FDA was unable to accept medical product applications that required a user fee during the shutdown, delaying the initiation of reviews for several products.
- The appearance comes a day after Rep. Tom Emmer, R-Minn., introduced a bill to allow FDA to accept new medical device applications and user fees during a government shutdown, a proposal lobbied for by AdvaMed.
The device lobby told reporters shortly before the shutdown ended that a typical month sees roughly 300 device applications to the agency, potentially creating a backlog of product reviews that could stretch agency bandwidth and resources. That fear was echoed by a key lawmaker Wednesday.
"While the full impacts from the shutdown will not be known for some time, there are undoubtedly accrued backlogs of inspections, delayed drug and medical device reviews and potentially exhausted pools of user fees as a result of the shutdown," subcommittee Chairman Sanford Bishop, D-Ga., said in his opening statement. "I'm very concerned about a future shutdown."
But despite the 35-day government shutdown, FDA said it expects to complete review of the medical device and drug applications within a normal timeframe.
"With continued hard work and careful planning by our medical product centers, we will work to review this bolus of drug and medical device applications in timeframes that are consistent with our user fee goals," Gottlieb said in his prepared remarks.
It is unclear how many applications FDA received after the shutdown ended. A spokesperson told MedTech Dive 236 510(k)s were cleared during the shutdown, but declined to offer details on new application numbers since the government reopened or how many devices are currently in queue to be reviewed.
Gottlieb pledged the effort to maintain user fee timeline goals will not impact FDA's "gold standard for safety and effectiveness," noting that it is imperative "patients continue to have access to the treatments they need."
At the same time, the agency is lowering its inspection goals for the year.
"We won't be able to conduct as many inspections of food and medical product facilities, and reviews of imports, as we had originally planned. This is because we focused on the highest risk establishments during the lapse, and many other types of inspections didn't take place," Gottlieb said in his written statement.
A spokesperson for Emmer told MedTech Dive the lawmaker worked with FDA to learn what the legislation would allow them to do under a shutdown. An FDA spokesperson said while the agency often provides technical assistance to Congress, it does not comment on specific legislation.
AdvaMed maintains the Emmer legislation would help ensure medical devices are able to move through FDA in the event another government shutdown presents itself, spokesperson Mark Brager said.
- Rep. Emmer The Medical Innovation Never Stops Act
- House Appropriations Committee FDA Commissioner Scott Gottlieb prepared testimony
- House Appropriations Committee FDA – Status of Operations Hearing
- MedTech Dive Device lobby pushes bill to let FDA take user fees amid shutdown
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