Organizations representing device manufacturers are heralding the passage of the 21st Century Cures Act, which advanced through the U.S. House of Representatives in a 344-77 vote.
Stephen J. Ubl, president and CEO of industry trade group AdvaMed, says the bill incorporates provisions that will enhance innovation. “This includes key improvements to FDA’s premarket program for medical devices — most significantly the establishment of an expedited pathway for breakthrough, innovative technologies — which will increase the efficiency, predictability and transparency of the agency’s review process and improve patient access to the best in medical progress,” he said in a prepared statement.
However, while the group applauds the legislation’s passage, it continues to express concern about a provision that would apply Medicare rates for durable medical equipment to Medicaid.
Mark Leahy, president and CEO of the Medical Device Manufacturers Association, also expressed appreciation for the House’s work, saying in a prepared statement that his organization will cooperate with Congress to improve the measure.
During a Rules Committee meeting ahead of the vote, two device-related amendments were adopted. One proposed by Rep. Mike Fitzpatrick (R-Pa.) encouraged recording unique device identifiers at the point of care in electronic health record systems to enhance the availability of data for postmarket surveillance. The House voted to include this amendment in the final bill.
Fitzpatrick had offered seven other amendments that focused on getting unsafe devices off the market, particularly power morcellators. These devices are used to remove uterine fibroids and have been linked to spreading cancer in women. “What happened with the power morcellator … should never be allowed to happen again,” he said on the floor. All the other amendments were rejected before the House considered the bill.
Another amendment, offered by Rep. Jared Polis (D-Colo.) called for a report on the risks and benefits of a two-tiered approval process that would allow medical devices to come to market provisionally if they’ve demonstrated safety but not efficacy. “This solves a real problem in the world,” Polis said, adding that the long period of review by the FDA makes bringing devices to market very expensive.
Polis ultimately withdrew the amendment after concerns were voiced. “I believe it’s got merit,” said Rep. Fred Upton, (R-Mich.), author of the bill, who said he would work with Polis to flesh out the idea.
Now all eyes have turned to the U.S. Senate. “The U.S. Senate Health, Education, Labor & Pensions Committee is working in a bipartisan manner on a similar initiative,” says a spokesperson for the HELP Committee. “The Senate hopes to have legislation by the end of the year.” — Elizabeth Hollis