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The FDA's Cozy Relationships With Drug Makers

Prior to yesterday's Senate Finance Committee hearing that took the FDA to task, the Washington Post featured a MUST-READ piece about the federal agency and its often too cosy relationships with the mega-billion drug companies, particularly during the Bush administration.

Almost always and, certainly in this case, the numbers speak volumes:

  • From 2001-04, three important drugs were recalled, compared to 10 from 1996-2001.
  • Cease-and-desist letters dropped some 70 percent, from 480 in 1996-2001 to 130 over the past four years.
  • Drug warnings about side effects almost doubled since 1996, mirroring a decrease in FDA enforcement.
  • About half of the FDA Center for Drug Evaluation and Research's (CDER) $500 million annual budget comes from user fees. That center is also where new drugs are evaluated prior to being approved for the U.S. market.

Another reason I'm so concerned about the current horrible state of health care in this country, according to this piece: The FDA looks like its leaning toward intervening in court cases on the side of drug and medical device makers sued by patients claiming they were harmed. In five different cases, the FDA has argued such lawsuits threaten to disrupt a regulatory system established to ensure the flow of new and useful products.

Washington Post November 18, 2004

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