For Immediate Release
	November 19, 2002
	Contact: Carol McKay
	202-835-3323 ext.114
	media@nclnet.org

NCL Cautions FDA against Switching New Nonsedating Antihistamines to OTC Status

Consumer Group concerned about proposed FDA action jeopardizing patient safety, shifting costs to consumers and setting a dangerous precedent

Washington, DC—Citing concerns over patient safety, cost shifting from insurers to consumers, and a dangerous precedent of switching a recently approved drug to over-the-counter (OTC) status without an adequate period for physician oversight, the National Consumers League (NCL) today strongly urged the Food and Drug Administration (FDA) to deny a recent petition to immediately push the prescription allergy medicine Clarinex to OTC status.

On April 15, 2002 , WellPoint Health Networks filed a citizen petition with the FDA asking the agency to switch the new prescription nonsedating antihistamine Clarinex, manufactured by Schering-Plough, to OTC. Claritin, an older nonsedating antihistamine (NSA) on the market, is expected to be granted OTC status this month.

In a letter delivered to FDA last week, NCL President Linda Golodner said, “The consequence of this forced OTC shift along with the other NSAs that WellPoint has petitioned on, would be to eliminate insurance coverage for the entire class of NSAs, reduce allergy patient contact with their physicians, and most likely encourage considerable numbers of allergy patients to choose cheaper, sedating antihistamines.”

Golodner added, “Forcing Clarinex to join Claritin OTC would remove this choice for consumers and potentially sever important patient-physician ties.” Currently, the FDA waits at least five years before switching a newly-approved drug to OTC status. Taking a new prescription medication OTC before there is any significant experience with it in a large population under physician supervision is a dangerous precedent, no matter how safe anyone may think the drug is.

The NCL also charged that the “elimination of a prescription option for consumers would shift treatment costs from health plans to consumers and substantially increase consumer out-of-pocket costs for use of these nonsedating antihistamines. FDA’s granting of the petitions on nonsedating antihistamines would effectively shift the entire class of NSAs over-the-counter, depriving consumers of any prescription NSA.”

Finally, NCL expressed concern that “increased use of sedating antihistamines would raise the risk of work-based accidents and injury, increase absenteeism and reduce productivity, and potentially impair the performance of many children in school.”

To view the full text of NCL’s letter to the FDA, visit www.nclnet.org.

The National Consumers League, founded in 1899, is America 's pioneer consumer organization. Our mission is to identify, protect, represent, and advance the economic and social interests of consumers and workers. NCL is a private, nonprofit membership organization. For more information, visit www.nclnet.org.

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