Tuesday, April 7, 2009

Did Donations Lead to FDA Approval of Medical Device?

The Wall Street Journal reports that according to campaign donation records, executives of ReGen Biologics Inc, a "small medical-device company, donated $50,000 in the 2008 election campaign to New Jersey Democrats who went to bat for the company's knee implant at the Food and Drug Administration." The three executives "began the donations in the fall of 2007, about a month after the FDA's second rejection of the medical device. The three together made only two other political donations totaling $6,000 this decade, according to the Center for Responsive Politics, a nonpartisan watchdog group." Recipients included Sen. Robert Menendez (D-NJ), Sen. Frank Lautenberg (D-NJ), Rep. Frank Pallone (D-NJ) and Rep. Steve Rothman (D-NJ). "Rep. Pallone is chairman of the Health Subcommittee of the House Energy and Commerce Committee, which oversees the FDA." Afterwards, the legislators "began pressing then-FDA Commissioner Andrew von Eschenbach to become involved in the ReGen case. ... Three of the lawmakers sent Dr. von Eschenbach a letter, and Sen. Menendez called the commissioner." The device was approved, but "is under investigation in the Senate Finance Committee."

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