Prescription Drugs Moving Over the Counter? Not So Fast
June 28, 2000 (Washington) -- The FDA does not have the authority to unilaterally mandate the switch of a prescription drug to over-the-counter (OTC) status, despite the rising cost of prescription drugs. Nor should the FDA consider allowing whole classes of prescription drugs to make the transition or change its current standards for determining which prescription drugs could be eligible for a switch from prescription to OTC status.
These were just some of the comments made Wednesday to a panel of agency officials during the first day of a two-day meeting convened to examine the FDA's current OTC policy. The comments Wednesday focused on ironing out the appropriate criteria for determining whether a product is eligible for OTC status, and what the FDA's role should be in determining whether a switch is merited. On Thursday, the FDA will also hear comments regarding what specific classes, if any, of prescription drugs should be made available on an OTC basis.
But, although there appeared to be a general agreement that consumers can benefit from self care and that self care is here to stay, the only entity clearly urging the FDA to consider taking a more proactive approach toward switching drugs was Kaiser Permanente, a provider of health insurance.
"Economic interests have to be balanced," Anthony Barrueta, JD, director of government relations at Kaiser Permanente, told agency officials. Kaiser is not advocating this position because it does not want to pay for these drugs, but rather because the move is in the interest of consumers, he said. The switch to OTC of certain prescription drugs -- such as less-sedating antihistamines -- will make them more widely available while easing the burden on the U.S. health care system, he explained.
Agreeing in part was Steve Francesco, founder of Francesco International, a private company devoted to promoting self medication. He said, however, that the FDA should encourage pharmaceutical companies to pursue OTC status by offering tax incentives rather than taking unilateral action. As for consumers losing their prescription drug coverage, "managed care is quite capable of developing an OTC budget," he said.