FDA may take active role in OTC switches

The Food and Drug Administration is looking at taking a more active role in switching prescription medications to over the counter. Under the current system, manufacturers of the drugs play the most active role in determining which drugs change to OTC.

At an FDA hearing on the subject, Pharmaceutical Research and Manufacturers of America General Council and Senior Vice President Russel A. Bantham testified that the current system is the best way to ensure that forced OTC changes do not put patients at risk or force manufacturers to assume unwanted liability risks.

"… [M]anufacturers have the most comprehensive and detailed knowledge of their drugs, including information bearing on whether a drug is a suitable switch candidate." Bantham told an FDA panel. "Taking all this into account, manufacturers are in the best position to decide when to begin the switch process and thereby avoid premature switches that could put some members of the public at risk."

Those in favor of the Food and Drug Administration taking more control of the process, however, claim that the pharmaceutical industry has a financial stake in delaying moving some drugs to over the counter, even though many of these drugs could be used safely without the supervision of a physician.

"Ideally, the agency would consider input from many sources [when considering an OTC switch] - including health professionals, consumers, medical researchers and insurers," said Health Insurance Association of America President Charles Kahn in his testimony before the FDA. "It is important that a drug be switched only when it's safe to do so, but when it's safe, making medications over the counter provides a direct cost savings to the consumer and may also save lives." PR