House subcommittee debates device remanufacturing definition, sends user-fees bill to next stage

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Dive Brief:

  • Members of the House Subcommittee on Health debated whether to define medical device remanufacturing during a markup of a bill to renew the Food and Drug Administration’s ability to collect user fees for the next five years.
  • A separate bill, introduced by Reps. Scott Peters, D-Calif., John Joyce, R-Pa., and Kim Schrier, D-Wash., would seek to define remanufacturing as repackaging a device, changing its labeling, or “engaging in any act that could significantly change the performance or safety specifications, or intended use” of the finished device. Lawmakers were split on the proposal, though not along party lines. 
  • The user-fee amendments bill was sent to the House Committee on Energy and Commerce by a 30-0 vote on Wednesday.  An amendment from Health Subcommittee Chair Anna Eschoo was included to clarify some items, including the scope of a report on rare disease and the intent behind a request to have the FDA hold a public meeting on cell and gene therapies.  

Dive Insight:

Proponents of the remanufacturing bill are looking to better distinguish between medical device remanufacturing, and servicing or repairs, saying it would improve patient safety. They cited a 2018 report from the FDA, which found that most complaints and adverse event reports alleging inadequate “servicing” of a device actually pertain to “remanufacturing.”

The FDA also stated that the ability for third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.

Schrier, one of the bill’s co-sponsors, said clarifying remanufacturing of devices, such as MRI machines or ultrasound equipment, is important to ensure they work as originally intended.

Co-sponsor Joyce listed an example where a component for an infusion pump was mass produced overseas for a different company than the original manufacturer. Thousands of pumps were recalled when the part failed, resulting in unregulated flow of drugs to patients. 

“While a statutory definition of remanufacturing like this legislative process may seem a small measure, it will go a long way not only to provide clarity to those who work on these devices, but ultimately protecting patients,” Joyce said. “We also stand ready to work with colleagues to make sure standard routine servicing and repair is excluded from this definition.” 

On Wednesday, 26 patient groups signed a letter to the Subcommittee on Health supporting the legislation. 

Critics of the proposal raised concerns about being able to service devices in a timely manner. Rep. Neal Dunn, R-Fla., said the bill “as written is problematic.” 

“No one would ever buy one of these pieces of equipment, unless they knew beforehand that they had reliable prompt servicing available for that equipment,” Dunn said, referring to his urology practice in Florida. “If you live in New York City, Atlanta, Miami, Chicago, we have a Siemens, GE, Varian rep in your city, ready to come to your side when you need them. But if you live in north Florida that’s just not true. I have to wait for somebody to fly in from one of those cities.” 

Another concern was whether the House subcommittee even had time to add a remanufacturing definition to the user-fee amendments since they must be renewed by Congress before Sept. 30. 

“I just don’t think that the policy on remanufacturing has reached a level of consensus, and it’s not going to reach a level of consensus by next week,” said House Energy and Commerce Committee Chair Frank Pallone, D-N.J. “If we tried to define remanufacturing, we would probably delay this bill weeks if not months.”

Eshoo, D-Calif., suggested going to the FDA and seeing if the agency could provide some language that might be consensus, adding that Center for Devices and Radiological Health Director Jeffrey Shuren had said that it would be helpful for the FDA to have clarity. 

“Now if it doesn’t work, I’m not the one that’s going to throw sand in the gears to have FDA issue pink slips,” Eshoo added. 

Other items that didn’t make it as amendments

Members of the House Subcommittee on Health also discussed some additional proposals that didn’t make it into the markup. They include: 

  • Requirements for medical device companies to continue to report shortages were brought up by Eshoo, who said the full committee could reach a “suitably tailored” solution to include it in the full markup.
  • Regulation of laboratory-developed tests was another item discussed in hearings over the last month, but didn’t make it in the markup text. Rep. Larry Bucshon, R-Ind., was disappointed that the package did not address the issue, adding that it is  “time to answer the call and address the pitfalls that exist in the current regulatory framework surrounding laboratory developed tests.” 
  • Rep. Debbie Dingell, D-Mich., recommended better safety monitoring after a device is cleared or approved, reflecting comments from patient advocacy groups that brought up recalled devices that caused serious harm to patients.

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