WASHINGTON – The U.S. House passed a fee-reauthorization bill for the Food and Drug Administration on Wednesday that would triple the amount of time medical device companies have to report malfunctions of some higher-risk products.
The change, outlined in a statement included by reference in the bill, would give companies 90 days to report product malfunctions, replacing the current 30-day deadline. The bill would also allow companies to summarize previously reported product malfunctions, rather than filing detailed reports on each case.
The measure is part of a five-year piece of legislation that sets user fees device makers pay to the FDA to help the agency reduce the time it takes to review products and get them to market. The current fee bill expires this year.
Proponents say the changes would simplify the needlessly repetitive process of reporting known product problems. Critics warn that the policy may lead to even fewer reports of malfunctions that FDA officials already acknowledge are underreported. Either way, the bill would preserve the 30-day reporting requirement in cases in which a medical device causes or contributes to an actual patient injury.
Under the House bill, known as the FDA Reauthorization Act of 2017, companies would be able to ask the FDA to extend reporting deadlines and to allow manufacturers to summarize product malfunctions in some of the most serious types of devices. The FDA will consider industry proposals for malfunction summary reports for Class III devices like pacemakers and neurosurgical balloons, as well as less-risky Class II devices like hip replacement kits and breast-feeding pumps.
The Senate, meanwhile, has not yet voted on companion legislation that would forward the FDA fees bill to President Donald Trump for final approval.
An FDA spokeswoman on Wednesday declined to comment on the new policy while it is being considered by the Senate, except to point out that the proposal for quarterly summary reporting would not apply to cases of patient complications, injuries or deaths.
The Washington-based med-tech trade group AdvaMed, whose members include most of Minnesota's largest medical technology firms, endorsed the new policy.
"AdvaMed supports the malfunction summary provision in the new user fee agreement," Janet Trunzo, a senior executive vice president with the lobbying group, said in a statement. "This provision will allow the agency to better focus its resources on more serious reportable events.
"Any incident involving serious injury or death is characterized as an adverse event, and therefore subject to FDA's reporting requirements and are not subject to the summary provision," Trunzo said.
She added that quarterly summary reporting would only be allowed for malfunction incidents that are well-understood and familiar to the agency; any new type of malfunction incident not previously reported to the FDA would still have to be reported to the agency as an individual report.
Minneapolis-based med-tech regulatory attorney Mark DuVal said "the last thing anyone would want" would be for important new information about device problems to be withheld from the medical community for an extra 60 days. However, the current system of reporting all product malfunctions on individual FDA medical device reports (often called "MDRs") creates a lot of work for companies but does little to inform doctors about issues that are already known.
"A lot of MDRs are really boilerplate and repetitive," DuVal said of the malfunction reports. "It would be nice to be able bundle them."
Consumer and research groups wonder whether the new rules would limit public access to information. Jack Mitchell of the National Center for Health Research said it's already difficult for experts to recognize developing trends in implantable medical device problems, and the proposed change would not help.
"It will exacerbate the tendency to underreport," Mitchell said. "Loosening up [the reporting rules] doesn't seem to us a good idea."
Dr. Michael Carome, director of health research at the consumer group Public Citizen, was relieved to learn that patient deaths and injuries would still be reported in individual reports within 30 days of a device maker learning of them. Still, understanding malfunctions as soon as possible can be a way of heading off deaths and injuries.
"Here we have a policy that makes [the] industry happy but puts public health at risk," Carome said.
Medtronic, Boston Scientific and Abbott Laboratories, device makers with large Minnesota operations, declined to comment on the legislation Wednesday, referring questions to AdvaMed.
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