Courts Repeatedly Slap Down FDA
November 19, 2002
Food and Drug Administration lawyers must shudder whenever they go to court nowadays. Lately, they've been losing a lot more important cases than they've been winning. Federal judges have slapped down the agency, tempering its aggressiveness and emboldening its industry adversaries.
Critics say the losses have injured the agency's credibility and left it legally vulnerable. In other words, when the agency is challenged by food or drug producers and must go to court, it no longer gets the benefit of the doubt.
Although the agency has lost 23 federal court cases and won 94 if one goes back to 1990, it has been on a losing streak on cases considered major since 1999.
- That year, an appeals court said the agency improperly rejected health claims advanced by a dietary-supplement maker.
- The following year, a court challenge by a conservative foundation opened the door to drug companies mailing out medical articles on unapproved, or off-label, uses of their drugs.
- Also in 2000, the Supreme Court rejected attempts by the FDA to regulate tobacco -- saying that "Congress has not given the FDA the authority that it seeks."
- This year, the Supreme Court struck down FDA rules barring pharmacies from advertising special "compounded" drug mixtures.
Most recently, a judge found that an FDA rule requiring some drugs to be tested on children "usurps" Congress.
"There certainly has been a history of overreaching at the FDA," says one observer, adding FDA officials "view themselves as watchdogs and to believe they have the authority to do whatever they think is the right thing -- and that limitations like lack of congressional authorization shouldn't stand in their way."
Source: Chris Adams, "FDA Isn't Holding Up in Court," Wall Street Journal, November 19, 2002
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