Food and Drug Administration officials acknowledged in a report late last month that "extreme" pressure from federal lawmakers influenced the agency's decision to approve a knee repair device in December 2008.
Four New Jersey Democrats — Reps. Frank Pallone and Steve Rothman and Sens. Robert Menendez and Frank Lautenberg — who reportedly received a combined $26,000 in campaign donations from Hackensack, N.J.-based ReGen Biologics, intervened on behalf of the company and its collagen scaffold device for knee repair, Menaflex, according to the FDA report. The agency's scientists had twice rejected the device, saying it did not provide a significant benefit to patients.
The agency's investigation found that former FDA Commissioner Andrew von Eschenbach, after urging from the 4 lawmakers, became directly involved in the case, agreeing to a meeting with ReGen executives, after which he told FDA staffers to "follow the science" when making a decision on Menaflex, according to an AP report.
"In the ReGen review, unusual perhaps unprecedented Congressional interest, the degree of senior agency official participation, and an aggressive company all exerted significant pressures on a complicated system of submission review," the FDA report concludes. The agency says it's re-evaluating the decision to approve Menaflex but has no plans to take it off the market. AP reports that the device has generated more than $700,000 in sales for ReGen since its approval last year. Efforts to reach ReGen for comment were unsuccessful.
Meanwhile, agency leaders are calling for a better system of handling contentious issues between companies and FDA staff. "The stronger our underlying process is, the less likely it will be interfered with," says FDA Principal Deputy Commissioner Joshua Sharfstein, MD.
Irene Tsikitas
