This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

FDA Plays Both Sides

Drug and device makers have started testing a simple but potentially powerful argument when their customers wind up hurt.

In a nutshell, they say this: It's not our fault. The Food and Drug Administration approved our products and deemed them safe for public use. A blessing from the FDA, which boasts a slew of medical experts, trumps your lawsuit any day.

In a twisted deal, critics claim, the FDA has stacked the deck against the very people it is supposed to protect. Early this year, the agency announced long-awaited labeling changes meant to better explain drugs and their side effects. But before issuing its new guidelines, the agency quietly added a preamble that could give its own stamp of approval more power than state laws allowing consumers to sue drug makers for failing to warn them of possible risks. Judges must now decide whether the rule applies to those cases or not.

Daniel Troy, former chief counsel of the FDA, explained the so-called Preemption Preamble in a recent issue of Legal Times.

"The FDA's bottom-line concern is that 'state-law attempts to impose additional warnings can lead to labeling that does not accurately portray a product's risks, thereby potentially discouraging safe and effective use of approved drugs,'" Troy wrote in the magazine's Oct. 9 issue. "A few courts have refused to defer to the Preemption Preamble and have rejected preemption on a variety of grounds. But few, if any, of those decisions carefully analyze the nature and extent of the FDA's decision-making or the degree of deference due to the FDA's views."
1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
JNJ $112.88 0.59%
MDT $79.50 0.86%
AAPL $93.24 -1.01%
FB $117.26 -0.68%
GOOG $701.43 0.82%


Chart of I:DJI
DOW 17,660.71 +9.45 0.05%
S&P 500 2,050.63 -0.49 -0.02%
NASDAQ 4,717.0940 -8.5450 -0.18%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs