New Legislation Outsources Medical Device Safety Reviews

Consumer groups and health advocates are concerned about legislation just passed by the House of Representatives that would make it easier for medical devices to reach the market and would put safety determinations in the hands of subcontractors paid by device manufacturers.

Documents just released by the Food and Drug Administration (FDA) reveal that device safety testing would be done by contractors certified by the FDA but paid for by the manufacturers, Bloomberg Business reports.

The medical device industry has faced extensive litigation over failed devices. Companies including Boston Scientific Corp., Johnson & Johnson, St. Jude Medical Inc. and Medtronic have faced thousands of lawsuits and paid hundreds of millions of dollars to patients who suffered painful and sometimes permanent injuries from faulty devices. Implanted defibrillators to stop heart attacks, hip implants, mesh to treat incontinence and pelvic organ prolapse, and bone-graft products have all been involved in litigation, according to Bloomberg Business.

Memos released through a public records request describe private meetings between FDA officials and AdvaMed, a trade group, to work on the text that legislators eventually approved. In 2014, the industry organization spent $2.36 million lobbying Congress, according to the Center for Responsive Politics.

The FDA described its relationship with device makers as routine. But outside observers find the degree of collaboration troubling. Michael Carome, director of Public Citizen’s health research group, said the meetings show the FDA has grown too close to the companies it regulates. “They characterized this as being standard practice. If this type of collusion is standard practice, that’s alarming,” Carome said, according to Bloomberg Business. “The FDA appears to be bending over backwards to please the industry and to address their interests above others.”

Susan Wood, a former assistant commissioner of women’s health at the FDA who now teaches health policy at George Washington University, agreed with Carome’s assessment. “FDA drafting legislation in consultation with outside entities, whoever they are, strikes me as unusual,” Wood said. “It gives a great deal more weight to the industry representatives on very specific legislation that affects both FDA and the industry, and others were not at that table.”

The FDA’s Center for Devices and Radiological Health (CDRH) and AdvaMed “worked together on the proposed language for most of the device provisions in” the Cures Act, according to an FDA memo from a meeting on August 7. Robert Califf, who was nominated in September to lead the FDA, was at the meeting, along with AdvaMed officials and executives from Johnson & Johnson and St. Jude Medical.

A former FDA official who requested anonymity said such close collaboration was once unheard of. Others suggested that, rather than bending to the industry’s will, the meetings might have been the agency’s best chance to modify a bill that lobbyists could easily push through Congress. The bill passed with broad bipartisan support.

The Cures act increases funding for the FDA and the National Institutes of Health, but also makes it easier for manufacturers to get new drugs and devices to market. The bill allows the FDA to rely on a wider range of evidence when approving new devices. The FDA could, for example, use published journal articles or case studies, which are to some extent anecdotal evidence, rather than original trial data submitted directly to the agency, Bloomberg Business says. Patient advocates are particularly concerned about provisions that would allow manufacturers to have device design changes evaluated by third parties rather than by the FDA.