AdvaMed Proposes Legislative Fix to Continue FDA Device Reviews During Shutdown
Contact:Mark E. Brager
WASHINGTON, D.C. – The medical technology community is already feeling the effects of the partial government shutdown. Under current law, FDA cannot review new fee-paying medical device applications for market clearance, and, as a result, the innovation pipeline is becoming dangerously clogged. New treatments and cures are stuck in a queue, and patients could see those effects.
To resolve the growing backlog and restore patient access, today the Advanced Medical Technology Association (AdvaMed) revealed a legislative initiative that would ensure FDA can access funds and conduct medical device reviews during the current shutdown and in future scenarios when agency appropriations lapse.
“Federal law should not deny FDA access to funds that companies have already agreed to pay the agency for the express purpose of device reviews,” said AdvaMed President and CEO Scott Whitaker. “Our legislative proposals will ensure FDA can continue doing its job during a government shutdown so that American patients can have timely access to safe and effective medical devices.”
AdvaMed’s legislative initiative has two components. First, Congress would allow FDA to continue processing new device applications and their associated user fees during a lapse in appropriations. This would ensure the agency’s medical device review process continues without interruption and would prevent the creation of any backlog.
Second, Congress would authorize FDA to tap into its pool of “unearned” user fees to fund device review activities during a lapse in appropriations. Every year, several companies essentially “pre-pay” application or facility registration fees to the agency but never submit an application or register a facility. When FDA is unable to return these fees or use them on the company’s behalf in the future, these fees simply accumulate in the agency’s account each year. At the end of FY 2017, these “unearned” fees amounted to $7.5 million.
“We’re putting forth common-sense solutions to a bureaucratic obstacle that is stifling the pipeline of new medtech innovations that patients depend on,” said Whitaker. “We can’t allow this situation to continue, and we want to work with Congress, FDA and other stakeholders on moving this legislative fix forward.”