FDA: FRIEND OR FOE?

May 30, 2007

The U.S. Food and Drug Administration (FDA) recently rejected Arcoxia, a new COX-2 inhibitor from Merck.  In explaining the FDA's disapproval, Robert Meyer, director of the agency's Office of Drug Evaluation, told reporters that "simply having another drug on the market" wasn't "sufficient reason to approve the product unless there was a unique role defined."

According to Hoover Institution scholars David Henderson and Charles Hooper, that position greatly exceeds the FDA's mandate to determine a drug's safety and effectiveness:

  • Arcoxia has been tested on over 34,000 U.S. patients.
  • It has been approved for use in England, Germany and 61 other countries in Asia, Latin America and Europe.

According to the FDA's literature, its mandate is to put together an expert FDA review team for new drug applicants to evaluate whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use.  Nothing in the FDA mandate requires that a drug has to be better than what's currently available in order to win approval.

Henderson and Hooper argue that in the worst-case scenario where Arcoxia is no better than existing drugs, it would compete with those drugs. Two centuries of economic theory and evidence show that competition is good. A new drug that competes with existing drugs would moderate drug prices and cause competitors to stay on their toes.

Source: Walter E. Williams, "FDA: Friend or Foe?" Townhall.com, May 30, 2007.

 

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