Should FDA Force Switching of Rx Drugs to OTC?

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Jody Clarke, 202.331.2252

Washington, D.C., April 23, 2003—Does the Food and Drug Administration have the authority to force drug manufacturers to switch prescription-only drugs to over-the-counter?  Not according to the Competitive Enterprise Institute and the American Association of Physicians and Surgeons.  Comments were filed this week on behalf of the two groups over an insurance industry petition requesting a mandatory switch to over-the-counter status for certain allergy prescriptions.


“The petition filed by WellPoint Health Networks was done in the alleged name of lowering drug prices,” says Sam Kazman, CEI’s general counsel.  “But depending on your health insurance plan, it can actually cost more for over-the-counter drugs.  That’s what has happened with the popular allergy drug Claritin that is now available only over-the-counter.  Whether a drug keeps it prescription status should be up to its manufacturer, not FDA or the insurance industry.  That’s especially important given the huge cost of developing new drugs.”


The FDA was established as a health and safety regulator to ensure the appropriate steps are taken regarding the safety of drugs on the market.  If WellPoint’s petition were successful, says Kazman, then it would expand FDA’s authority and allow economic considerations to intrude into the scientific process, which would not necessarily benefit consumers.


CEI successfully challenged another attempt by FDA to expand its authority.  Last fall an appeals court ruled that the FDA was trying to illegally expand its powers to regulate the practice of medicine under the agency’s “Pediatric Rule,” which involved off-label uses of medications for children.


The comments submitted to FDA on behalf of CEI and AAPS

are available online in pdf format.



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