Henderson and Hooper argue that this 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. Moreover, it has been approved for use in England, Germany and 61 other countries in Asia, Latin America and Europe. Meyer's explanation is nothing less than fascist arrogance.
According to the FDA's literature, its mandate is: "Once a new drug application is filed, an FDA review team -- medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts -- evaluates 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.
While Henderson and Hooper don't say it, I smell a rat. Arcoxia is produced by Merck, which has several major competitors in the COX-2 inhibitor market. Some scientists on the FDA's advisory panel have paid affiliations with companies who'd benefit from less competition.
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