NCPA - National Center for Policy Analysis


February 18, 2008

The Food and Drug Administration (FDA) wants to allow drug companies to give doctors information about unapproved uses of prescription drugs, a controversial move that is already drawing objections from Capitol Hill, says the Wall Street Journal.

The ability to get flattering data about off-label uses in front of doctors' eyes is important to the companies because of the business heft of such uses.  Consider:

  • Off-label uses of prescription drugs make up an estimated 21 percent of overall drug use, according to a 2006 analysis published in the Archives of Internal Medicine.
  • Around 31 percent of psychiatric-drug prescriptions, including antidepressants, antianxiety and antipsychotic medications, are off-label, according to the 2006 analysis, and IMS Health says that group had 2006 U.S. sales of about $26 billion.
  • The percentages were even higher for some other types of medication: an estimated 42 percent of asthma medicines were used off-label, according to the 2006 study -- a class that IMS estimates brought in $7.8 billion in U.S. sales that year.

The FDA's move is already raising objections from industry critics.  Democratic Rep. Henry Waxman (D-Calif.) wrote to the agency urging it to hold off on issuing the guidelines, which he argued would create a "large loophole" in the laws against off-label promotion.  "It's a conflict of interest for the company to be promoting sales when they haven't been able to establish that a drug is safe and effective through the rigorous FDA process," Waxman said.

But industry officials said doctors and patients benefit when physicians get reliable scientific information.  "Companies do want to provide information that's truthful and non-misleading," said Jeffrey Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America. Peer-reviewed medical journal articles "should be distinguished from materials that are promotional."

Source: Anna Wilde Mathews and Avery Johnson, "Boost for Off-Label Drug Use," Wall Street Journal, February 16, 2008.

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