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Consumer Advocates Concerned with New Legislation that Outsources Medical Device Safety Determinations

Dec 22, 2015

The 21 Century Cures Act, recently passed by the House of Representatives, makes it easier for drugs and medical devices to reach the market but also puts safety assessments in the hands of subcontractors paid by device manufacturers, a concern to patient safety advocates.

The Food and Drug Administration (FDA) has released documents that reveal device safety testing would be done by contractors certified by the FDA but paid for by the manufacturers, according to Bloomberg Business .

Devices have become increasingly complex and, at the same time, more people are relying on medical devices to improve their quality of life or even to sustain life. Safety advocates say device approval needs to be more rigorous.

In recent years, the medical device industry has found itself embroiled in extensive litigation over defective devices or devices that cause problems in unapproved uses. Boston Scientific Corp., Johnson & Johnson, St. Jude Medical Inc. and Medtronic are among the manufacturers involved in lawsuits. These and other companies have paid hundreds of millions of dollars in damages to patients who suffered painful, sometimes permanent, injuries from faulty devices. Implanted defibrillators, joint replacement implants, mesh implants to treat incontinence and pelvic organ prolapse, and bone-graft products have all been targets of lawsuits, according to Bloomberg Business.

Memos released in response to a public records request describe private meetings between FDA officials and AdvaMed, a trade group, in which they worked on the text that the House eventually approved. The organization spent $2.36 million in 2014 lobbying Congress, according to the Center for Responsive Politics.

While the FDA describes its relationship with device makers as routine, outside observers are troubled by the degree of collaboration. Michael Carome, who is the director of Public Citizen's health research group, said the meetings show the FDA is too close to the companies it regulates. "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, said it strikes her as "unusual" for the FDA to draft legislation in consultation with outside entities. She said the practice gives a "great deal more weight to the industry representatives . . . 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, as were AdvaMed officials and executives from Johnson & Johnson and St. Jude Medical.

If the bill becomes law, it would allow the FDA to use different types of evidence in approving new devices, for example, published journal articles or case studies, rather than original trial data submitted directly to the agency, Bloomberg Business says. Patient advocates are concerned that case studies do not have the objectivity and rigor of well-designed clinical trials. They are also concerned about provisions in the law allowing device design changes to be evaluated by third parties rather than by the FDA.

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