November 8, 2002
Food and Drug Administration
Center for Drug Evaluation and Research
5630 Fishers Lane
Rockville, MD 20857
Re: Docket No. 02P-0163/CPI
Dear Food and Drug Administration:
The National Consumers League (NCL) is a private, nonprofit advocacy group representing consumers on marketplace and workplace issues. NCL is the nation’s oldest consumer organization.
We are writing in response to a citizen’s petition filed on April 15, 2002 by WellPoint Health Networks requesting that FDA switch the prescription non-sedating antihistamine Clarinex (desloratadine) over-the-counter (OTC). We are concerned that this switch may not be in the interest of consumers. One reason is that Clarinex has not been on the market long enough to have accumulated sufficient experience to adequately judge its safety for consumers in a self-medicating environment. Another reason is that the primary consequence of a switch to OTC status would be to raise the cost of treatment for consumers with allergic rhinitis or chronic idiopathic urticaria. Finally, we believe an OTC switch will result in chronic continuous use that has not been established as safe and effective in clinical trials.
NCL urges the FDA to reject WellPoint’s petition that it immediately switch Clarinex (desloratadine) to OTC status on the basis that it has a similar safety profile to Claritin (loratadine). The petition asserts that since Schering-Plough Corporation filed a supplemental New Drug Application in March 2002 to switch Claritin (loratadine) OTC, and clinical trials to date for Clarinex indicate that it has similar safety and efficacy to Claritin, the FDA should switch Clarinex as well. Clarinex itself has only been in the market a mere nine (9) months since its approval in February 2002.
Current FDA practice is not to approve a request or petition to switch a “new drug” to OTC on first application. FDA requires that to be recognized as safe and effective for OTC use, a drug must have been introduced first into the prescription drug market and have been used as a prescription drug “to a material extent” or “for a material time.” A “material time” is generally considered to be five consecutive years. The purpose of this requirement is to ensure that a drug has had sufficient use under physician supervision in a large population to enable rare but potentially serious adverse reactions and side effects to materialize and be detected before a drug is approved for self-medication and OTC sale.
To that end, clinical trials generally required for initial product approval do not involve sufficient numbers or duration of exposure to evaluate low incidence events or latent events no matter how serious. While such limited studies may well establish safety and efficacy and a beneficial risk-benefit ratio for patients under direct physician supervision, additional experience should be acquired before physician oversight and attention to potential effects is removed.
The petition’s contention that Clarinex clinical trial data provide sufficient information on this drug to establish that it has a similar safety profile to Claritin is troubling. FDA’s acceptance of this argument would represent a serious shift in agency policy requiring extensive market experience to reveal rare consequences and agency policy that chemical changes to a product may result in unpredictable effects. While desloratadine is a metabolite of loratadine and appeared in clinical trials to have similar safety characteristics to loratadine, there is always a potential that a modification to a chemical entity will reveal unanticipated effects as experience is accumulated in diverse populations. Given the FDA’s recent experience in withdrawing approvals for several drugs after severe reactions or side effects were revealed in large population use, NCL believes the FDA should not place consumers at risk by moving Clarinex OTC before it has had sufficient market experience. Continued physician oversight is crucial.
NCL is concerned as well about the consequences for consumers’ ability to treat their allergies if Clarinex is forced by the FDA to go over-the-counter. FDA’s expected approval in November 2002 of Claritin for OTC sale will provide consumers a choice of self-medicating. This choice will enable allergy sufferers to optimize their treatment with nonsedating antihistamines and permit those who want or need to maintain physician contact regarding their use of this medication to do so. Forcing Clarinex to join Claritin OTC would remove this choice for consumers and potentially sever important patient-physician ties.
In addition, elimination of a prescription option for consumers would shift treatment costs from health plans to consumers and substantially increase consumers’ out-of-pocket costs for use of these nonsedating antihistamines. FDA’s granting of the petition on nonsedating antihistamines would effectively shift the entire class of NSAs over-the-counter, depriving consumers of any prescription NSA.
The consequence of this forced OTC shift would be to eliminate insurance coverage for NSAs, reduce allergy patient contact with their physicians, and most likely encourage considerable numbers of allergy patients to choose cheaper, sedating antihistamines. 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. NCL believes that although insurers stand to save substantial amounts of money on physician visits and drugs from an OTC switch, their enrollees and other consumers would pay the price through reduced health insurance coverage and increased health care costs.
We, therefore, urge the FDA to uphold its strong policy as a guardian of the health and safety of the public and deny the petition to move Clarinex (desloratadine) over-the-counter at this time.
Sincerely,
LINDA F. GOLODNER
President