The House Energy & Commerce Committee has unanimously approved the FDA user-fee bill that would reauthorize the Medical Device User Fee & Modernization Act (MDUFMA) with its FDA-industry agreement intact.
The bill, the FDA Reform Act of 2012, sailed through the health subcommittee May 8 and, two days later, through a markup session by the full committee, 46 to 0, making its consideration on the floor of the House imminent.
MDUFMA, the piece of the act dealing with medical devices—the broad FDA Reform Act (HR 5651) also covers user fees for drugs, biosimilars and various administrative issues—calls for industry to double the user fees it pays FDA, to nearly $600 million, in exchange for faster and more consistent reviews. The current user-fee structure will expire Sept. 30.
The legislation will need to come before the Senate. Still, several observers noted that the double-barrel momentum may signal bipartisan desire to finalize a version prior to the Supreme Court’s late-June decision on the Affordable Care Act. Similar legislation passed muster with the Senate’s Health, Education, Labor and Pensions Committee last month.
“This (House) bill represents a significant bipartisan achievement. Its consideration is a model for legislative action,” said Henry Waxman, the California Democrat who serves as ranking member of Energy & Commerce, in remarks prepared for attendees of the May 10 markup session. “When we started this process, I had a lot of concerns about many of the Republican proposals relating to medical devices. But we worked together to address those concerns and to assure that nothing in this bill will take us backwards in terms of patient safety.”
Fred Upton of Michigan, the committee’s Republican chair, was similarly sanguine. “The FDA Reform Act contains important metrics that will hold the FDA accountable for its performance, will help provide new therapies to our nation’s children, significantly improve scientific exchange at FDA’s advisory committees and ensure transparency and public input in the development of FDA’s guidance documents,” he said.
Industry and government watchdogs have expressed their doubts. Testifying before a Feb. 15 hearing Energy & Commerce hearing on MDUFMA’s impact on jobs, innovation and patients, Consumers Union urged greater diligence. “At a time when the device industry has seen large-scale safety failures of some of its products, it is troubling that the main focus of conversations between industry and the agency that regulates it is on speeding up review times,” said CU senior policy analyst Lisa Swirsky.
Energy & Commerce has posted a fact sheet on the FDA Reform Act.