Culture of Corruption, Part Forty-Three
I am not sure if this is pure, ipso-facto corruption, but it certainly smells funny:
The U.S. Food and Drug Administration violated procedures last year when it approved a knee repair device even though its own scientists recommended against approval, agency officials said Thursday.
The device, called Menaflex, is made by New Jersey-based ReGen Biologics and is used to help surgically repair knee damage — specifically, damage to the meniscus. But, a report released by the agency Thursday found that some FDA scientists had recommended against approval.
“There were numerous departures from processes, procedures and practices, and there were problems with the review process for the device,” Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner, said during an afternoon teleconference.
In addition, the FDA report noted that four New Jersey Democratic lawmakers — Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — made inquiries to agency officials about the device’s approval status.
In theory, there’s nothing wrong with a lawmaker calling up FDA and saying, “A company in my state/district has a product up for review; how’s the review going?” But that’s treading a fine line, and influence and corruption are on the other side of the line.