Medical Device Makers Push Products
Big drug makers and medical device makers spend millions of dollars every year promoting their products to doctors and healthcare providers. Less known is the fact that they also spend millions lobbying Congress and agencies to push approval of their products. This was especially true in the last administration which had a reputation of bowing to the requests of big business, many times at the expense of patients.
The FDA released a report last Thursday that said four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees.
FDA reviewers had determined that ReGen Biologics Inc.'s Menaflex device was "unsafe" because it often failed, forcing patients to get another operation. Still, in response to 'extreme' 'unusual' and persistent pressure," agency managers approved the device for sale, the report indicated.
Joshua Sharfstein, the agency's principal deputy commissioner, said the report shows there were 'definite threats' to the integrity of the FDA's medical-device review process, and as a result, the agency is now reconsidering its decision on the device.
The report offered several recommendations to insulate FDA staff from outside pressures, all of which," Sharfstein said will be adopted.
In fact, the report said that after the FDA twice rejected the company's request for fast-track approval, ReGen enlisted the support of New Jersey lawmakers, who called then-FDA Commissioner Andrew von Eschenbach on the company's behalf. Eschenbach then "became involved in the case and pressed reviewers to issue a decision quickly
