The House Energy & Commerce Committee voted resoundingly to approve the 21st Century Cures Act, sending the measure — which includes a provision to ease U.S. device trials by allowing a single central review board to monitor multiple trial sites — to the House floor for consideration.
Currently, device trials must be cleared by a local institutional review board at each research site, a requirement AdvaMed calls unnecessary and redundant. JC Scott, head of government affairs at the trade group, says the FDA is aware of the problem but lacks the power to change the policy.
In another change, the FDA overhaul package would simplify informed consent rules around device trials that pose no more than minimal risk to the patient, as long as they include appropriate safeguards.
In addition to clinical trial reforms, H.R. 6 would allow devicemakers developing so-called breakthrough technologies to ask the FDA for a priority review designation before submitting an application.
The bill also clarifies and expands the definition of “valid scientific evidence” in the context of device applications, ensuring that manufacturers can submit peer-reviewed journal studies, results from overseas trials and registry data.
Further, the bill would expand the humanitarian device exemption program to cover devices treating conditions affecting up to 8,000 people in the U.S., double the current definition.
Rules around medical device software would also be updated, limiting the FDA’s authority to regulate products that don’t pose a risk to patient health. Finally, the law would allow devicemakers to use third-party inspectors more broadly ().
The legislation includes an amendment from Reps. Anna Eshoo (D-Calif.) and Leonard Lance (R-N.J.) that would exempt FDA user fees from sequestration – a provision Eschoo said would ensure that private dollars are not locked up.
Scott praised the user fee amendment, but expressed reservations about a provision in the bill’s offset package that would apply Medicare payments for durable medical equipment to Medicaid patients as of 2020.
Industry has had concerns over low rates set through Medicare competitive bidding and there hasn’t been a good analysis done of possible patient access issues, he says.
Committee chairman Fred Upton (R-Mich.) hinted that more amendments might be added before the bill hits the House floor for approval. Scott declined to speculate on the chances of equivalent legislation in the Senate, where the issues are being researched.