Device approval exposes political pressure on FDA
WASHINGTON (AP) ¿ The Food and Drug Administration has taken the unprecedented step of acknowledging that it buckled to "extreme" pressure from Capitol Hill in its approval of a knee repair device last year. While FDA officials call the situation an anomaly, experts said Friday there is nothing to stop similar political lobbying from influencing future decisions.
In a sweeping critique Thursday, FDA leadership said the agency failed to protect its scientists from outside pressure after they twice rejected ReGen Biologics' Menaflex device.
The Hackensack, N.J.-based company ultimately won approval last December after enlisting the support of four New Jersey lawmakers, who urged then-FDA Commissioner Andrew von Eschenbach to intervene on the company's behalf.Approval came despite protests by FDA scientists that Menaflex ¿ which reinforces damaged knee tissue ¿ provided little, if any, benefit to patients. ___ Reports on manufacturing, housing weigh on stocks Stocks fell for a third day Friday after disappointing reports on manufacturing and home sales further dampened enthusiasm about the state of the economy.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV