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Posts Tagged ‘Regen Biologics’

The FDA has announced that it will revoke approval of a medical device for injured knees because, as Public Citizen testified in 2008, the Menaflex device made by New Jersey-based ReGen Biologics should never have been approved in the first place.

Public Citizen researchers told the FDA there was no scientific evidence to support the device’s approval. Subsequent events revealed how political pressure from some New Jersey members of Congress forced the deviceย  through the FDA approval process. Dr. Jonas Hines, the Public Citizen researcher who appeared before the FDA, said that political shenanigans “cast a shadow on the ostensibly objective approval process.” The FDA’s decision to revoke the ReGen approval should be the agency’s first step in overhauling the medical device approval process.

“Although we are pleased that the FDA acknowledges its mistake in clearing the ReGen Menaflex, this decision is long overdue,” Jonas said. “We hope this represents the beginning of a new era in medical device approval, one in which the health of Americans supersedes any industry threat of the stifling effect on innovation of improvements in regulation.”

Gardiner Harris in the NYT writes that the FDA “had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”

So is it a “new day” at the FDA? It might be a little premature to bust out the champagne, but following the decision earlier this month to pull the dangerous diet pill Meridia from the shelves, we will go so far to say that October has been a good month for patients.

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