FDA's 'flawed' device pathway persists with industry backing

WASHINGTON -- Roughly 3,000 medical devices enter the U.S. market every year through a system generally requiring little or no patient testing to verify safety and effectiveness.

Unlike new pharmaceuticals, most medical devices reviewed by the Food and Drug Administration are cleared based on similarities to already-approved devices, not specific clinical trial testing.

The agency's streamlined review system has been blamed for a string of defective devices coming to market, including hip replacements leaching metal debris into patients' joints and pelvic mesh puncturing internal organs. Still, the 42-year-old system persists, in part because of the power of the medical device lobby, which floods Washington with hundreds of lobbyists and millions of dollars.

On Monday, the FDA proposed changes to the system to push manufacturers to incorporate more up-to-date safety features into their devices. FDA commissioner Dr. Scott Gottlieb described it as "the most significant modernization" of the agency's review pathway in a generation, though some of the reforms could take years to implement. The FDA's move came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press.

Nearly a decade ago, the FDA had responded to criticism of the system by asking the Institute of Medicine to study whether the process was helping the FDA fulfill its dual goals of protecting patients and promoting medical innovation. The nonpartisan group -- now part of the National Academies of Sciences, Engineering and Medicine -- advises the federal government on medical matters.

Industry observers assumed the institute would seek to bolster safety standards by suggesting reforms to the streamlined process, which clears more than 95 percent of medical devices now on the market. But the group concluded the process offered little assurance devices were actually safe and effective and said there was no evidence to support industry's claim the system supported "innovation."

Instead of trying to improve a "fundamentally flawed" system, the experts recommended the FDA develop a new framework for medical device review.

Dr. David Challoner, a former university administrator who led the study, said his group came under fire from industry long before its findings were released.

He had assembled a 12-member panel of medical experts, including several device industry consultants. But the industry thought it should have more representation, said Challoner, who himself had previously served as a board director for a device manufacturer.

As the committee was finalizing its report, a University of Minnesota professor co-authored a paper in May 2011 arguing the FDA could be "legally prohibited" from using any of the committee's recommendations because industry was not adequately represented. The paper did not disclose the co-author, Ralph Hall, previously had been an executive for the device maker Guidant and had also worked for an industry lobbying group. Hall did not respond to multiple requests for comment.

In June, another industry ally weighed in. The conservative Washington Legal Foundation filed a petition to the FDA, saying the agency would be breaking the law if it took advice from a panel not "fairly balanced." Richard Samp, the group's chief counsel, said his group intervenes when appropriate to urge agencies to follow the law.

By July 2011, the FDA rejected the findings of the report it had commissioned, saying its longstanding review process should stand.

The FDA said in a statement to the AP it can -- and sometimes does -- require "exhaustive testing" for devices reviewed through the streamlined pathway, but patient testing and clinical trials are not appropriate or needed for most lower-risk devices, such as syringes.

Lawmakers later introduced a flurry of industry-backed proposals to loosen FDA oversight. One failed measure would have even rewritten the FDA's mission to include "job creation."

Since then, the relationship between regulators and the regulated has grown closer.

Federal lobbying records analyzed by the not-for-profit Center for Responsive Politics show the 50 largest device manufacturers and trade groups have spent more than $140 million to deploy 450 lobbyists in Washington since 2013.

The industry's chief lobbyist -- the Advanced Medical Technology Association, or AdvaMed -- said there's no evidence requiring additional patient studies would improve safety. Regarding Challoner, AdvaMed said the device industry "was nothing but supportive" and his committee "failed to provide any meaningful recommendations" to improve the FDA's review system.

In August 2015, AdvaMed lobbyists met with the FDA to discuss the group's "priorities for the year," according to an FDA memo of the meeting, first published by Inside Health Policy. At the meeting, AdvaMed and the FDA discussed how they had "worked together" on provisions of a bill then moving through Congress, the 21st Century Cures Act.

The measure, later signed into law, required the FDA to emphasize the "least burdensome means" for reviewing medical devices and to train staff in the concept. That effectively gave manufacturers a legally binding tool to challenge FDA requests for more information during the review process.

The FDA said in a statement the "least burdensome" requirement is misunderstood and is intended to eliminate "outdated, unnecessary burdens." It does not change the agency's approval standards, the FDA said, adding streamlined reviews are generally reserved for lower-risk devices not truly "new products." When appropriate, the FDA said, it requires patient testing.