FDA Rips its Own Approval Process

October 6th, 2009 | Sources: Wall Street Journal

Subjects: ,

The new deputy commissioner of the Food and Drug Administration has criticized his Agency’s approval of ReGen’s Menaflex knee device last December in a report claiming that “extreme” pressure from New Jersey Democratic Congressmen compromised the integrity of the process.

In his report, Joshua Sharfstein asserted that the Congressional heat was “the most extreme (the FDA’s Congressional liaison) had seen. In addition, “the FDA’s acquiescence to (ReGen’s) demands was unprecedented.”

KneeThe events undermined the Agency’s ability to “counter the suggestion that lobbying on behalf of ReGen affected the decision,” according to the report which was obtained by the Wall Street Journal.

The Congressmen, Senators Robert Menendez and Frank Lautenberg, and Representatives Frank Pallone Jr. and Steve Rothman apparently encouraged the Agency to hasten its review of New Jersey-based ReGen’s device, which is a collagen meniscus implant designed to guide new tissue growth following surgical repair in patients with tears or loss of meniscus tissue.

Sharfstein added however, that his report does not constitute grounds for Menaflex recipients to panic and that the device remains on the market. The Agency, he said, will begin a review to determine whether that continues to be the case.

The 4 Congressmen countered that their involvement was a simple case of helping a constituent get fair treatment from the FDA.

FDAThe case could have far-reaching implications for the medical device industry. It is one reason why the FDA has undertaken a comprehensive review of the 510 (k) program which fast-tracks approval of medical devices by requiring less rigorous clinical testing before approval is granted.

ReGen claims that its product is safe and effective. Former FDA Commissioner Andrew von Eschenbach wasn’t available to comment.


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