(Bloomberg) — The U.S. Food and Drug Administration and the $110 billion medical device industry held a series of private meetings earlier this year to jointly craft a major bill that loosens — wait for it — medical device regulations.
While lobbyists helping write legislation isn't particularly new, the level of cooperation between regulator and regulated on the 21st Century Cures bill, revealed in recently released agency documents, has earned the scorn of some consumer groups. The 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 paid by device manufacturers.
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 FDAofficials 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.
