FDA, device makers, patient advocates lock horns

In MedPage Today, Joyce Frieden breaks down the FDA’s day-long town hall meeting that brought together device makers, federal officials and patient advocates last week. Frieden’s report points to more contention than consensus, with the debate crystallizing around a few key issues, most of them related to the FDA’s device approval process.

Predictably, the device makers’ griped about the FDA approval process, one which patient advocates say is lacking in clinical trials, especially long-term ones.

“The overall tone is that the predictability and certainty of our interactions with the FDA are worsening,” Paul LaViolette, venture partner at SV Life Sciences, said at the session, which was part of the Transcatheter Cardiovascular Therapeutics meeting. “Where is the problem? It’s at the review level.”

LaViolette, who is also a member of the board of directors of AdvaMed, a trade group for the medical device industry, said he had “a sense that turnover at the reviewer level is intensifying. Companies report that four out of every 10 submissions experience turnover at the reviewer level. So we have reviewers that are less confident in making a decision, and more meetings are required.”

The FDA blames the slowing approval process in part to the increased reliance on clinical trials conducted outside the U.S., which introduces a swarm of additional variables which regulators must take into account. The recession and an accompanying blow to the venture capital supply and investor confidence also helped reduce the number of devices approved, an industry representative said.

Other topics of discussion included the industry’s request that the FDA’s approval for use and CMS’ approval for Medicare reimbursement be “harmonized,” as well as the FDA’s request that industry look into ways to increase minority patient participation in clinical trials, which is disproportionately low at present.

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