Bush’s Last-Minute Gift to Drug Manufacturers

Monday, February 02, 2009

Just days before President George W. Bush left office, the Food and Drug Administration (FDA) issued new guidelines that make it easier for drug manufacturers to market what are known as “off-label” prescription drugs. The FDA, after clinical trials, approves drugs that can be prescribed. Although drugs are approved for specific conditions and uses, there are no regulations preventing doctors from giving them to patients for other conditions. However, it is—or was—illegal for drug manufacturers to promote or advertise drugs for uses not included on FDA-approved labels. This practice is so lucrative that over the past five years, drugs manufacturers have preferred to risk fines rather than give it up. In January 2009, Eli Lilly was penalized $1.42 billion for off-label marketing of the anti-psychotic drug Zyprexa, and Pfizer made public the fact that it had agreed to pay $2.3 billion to halt investigations into its marketing of Bextra and other pain-killing drugs. The Bush guidelines, opposed by Bush’s own Department of Veteran Affairs, allow drug manufacturers to send to doctors selected medical journal articles that support their claims.



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