Safety Outsourced Under Bill Blessed by FDA, Medical Device Makers

Consumer groups see `alarming' collaboration with lobbyists on legislation approved by House.

An employee works on the production line at a Medtronic Inc. medical device manufacturing facility in Tijuana, Mexico.

Photographer: David Maung/Bloomberg

How would you like the safety of your pacemaker judged by a company on the manufacturer's payroll? That's a question U.S. patients may face under a bill crafted by the medical device industry and the agency that regulates it. 

While lobbyists helping write legislation isn't new, the level of cooperation between regulator and regulated on this year's 21st Century Cures bill, revealed in just-released agency documents, has earned the scorn of some consumer groups. The proposed law, passed by the House of Representatives, would make it easier for devices to reach the market and put safety determinations in the hands of subcontractors certified by the FDA, but paid by device makers. 

The industry has been under assault in courts across the U.S. as some devices failed and others were used for unapproved purposes. Companies including Boston Scientific Corp., Johnson & Johnson, St. Jude Medical Inc. and Medtronic Inc. have faced thousands of lawsuits and paid hundreds of millions of dollars to patients who suffered sometimes gruesome injuries from faulty devices. Internal defibrillators to stop heart attacks, hip implants, mesh to prevent incontinence and bone-graft products have all triggered litigation.

Memos released through a public records request describe regular, private meetings between FDA officials and AdvaMed, a trade group, to hash out the text lawmakers eventually approved. The industry organization spent $2.36 million lobbying Congress in 2014, according to the Center for Responsive Politics. Meanwhile, legislators held public roundtables about the Cures bill for a year before the vote.

The FDA described the relationship as part of a routine process. But outside observers called the degree of collaboration peculiar, or worse. Michael Carome, an opponent of the bill and 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. "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 agency who now teaches health policy at George Washington University, agreed. She has also raised concerns about the bill. "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 Aug. 7, a month after the bill passed the House. Robert Califf, who President Barack Obama nominated in September to lead the FDA, was at the meeting, along with AdvaMed officials and executives from Johnson & Johnson and St. Jude Medical.

One former longtime FDA official who requested anonymity said such close collaboration was once unheard of. Others suggested that, rather than bending to the industry's will, it 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 21st Century Cures legislation came from industry in the first place,'' says Mary Pendergast, a former FDA deputy commissioner. "This is part and parcel of the bigger way in which Congress runs its shop."

While the Cures bill increases funding for the FDA and the National Institutes of Health, it 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. For example, the FDA could consider published journal articles or case studies, rather than reviewing data from an original trial submitted directly to the agency.

Of particular concern to patient advocates is a provision that would outsource the job of certifying that changes to a high-risk device don't pose a danger. In other words, instead of going to the FDA to modify the design of a pacemaker, manufacturers would go a third-party company paid by the manufacturer to evaluate whether the change poses a safety problem.

The Senate is working on a companion bill but hasn’t made the text public yet. “For the Senate version of 21st Century Cures, [the FDA’s Center for Devices and Radiological Health] is currently working with AdvaMed to refine their regulatory strategy in a way that is agreeable to both parties,” according to an FDA background memo for the Aug. 7 meeting.

AdvaMed spokeswoman Wanda Moebius said the creation of the 21st Century Cures bill was a ``very open and inclusive process collecting input across the health care community via written statements, town hall meetings, roundtables and hearings." AdvaMed also disputed that the bill would weaken the "FDA’s robust standards" and said Congress was ultimately responsible for the content of the legislation.

FDA spokeswoman Jennifer Dooren characterized the collaboration as standard procedure. "FDA officials routinely meet with a diverse group of stakeholders including industry, patient groups and consumer groups," Dooren said in an e-mail. "Congress regularly asks us for technical assistance about how to modify language proposed by outside groups, as was the case here."

Dooren didn’t respond to questions about whether any other groups collaborated with the FDA on the text of the proposed bill. Neither the FDA nor AdvaMed would say how many times the groups met. Spokespeople for Johnson & Johnson and St. Jude Medical didn't respond to e-mails seeking comment. The FDA’s collaboration with AdvaMed was first reported last week by InsideHealthPolicy.

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