Venture capital firms with a stake in med-tech have donated more than $3.3 million over the last 5 years to legislators and political action committees devoted to changing the FDA’s medical device review protocols.
About 20 percent of those donations went to individuals and organizations directly advocating for reform at the FDA’s Center for Devices & Radiological Health.
Rep. Erik Paulsen (R-Minn.) alone received $74,000 in the month after a speech in which he called for reforms; most of those contributions came from venture capitalist executives, a New York Times investigation found.
Paulsen has since emerged as a prominent voice for the med-tech industry, urging a repeal of a 2.3 percent med-tech levy and promising to revamp FDA policies that he says are delaying life-saving technologies from hitting the U.S. market.
The attention and wealth of donations raised eyebrows among patient safety advocates, who argue for more stringent FDA review.
Patients groups have been especially wary in light of recent high-profile incidents such as the recall of Depuy Orthopaedics’ metal-on-metal hips, the controversy over transvaginal mesh products and Medtronic’s (NYSE:MDT) 2007 Sprint Fidelis recall.