Allergy Drugs Should Be Available OTC, Panel Says
An FDA advisory panel on Friday agreed with WellPoint Health Networks' contention that allergy drugs Claritin, Allegra and Zyrtec are safe enough to be made available without a prescription, the Washington Post reports. The 23-member panel voted 19-4 to recommend switching the status of Claritin and Zyrtec and 18-5 to change Allegra's status. The FDA generally follows the panel's recommendations, although they are not legally binding. Initiating the debate, WellPoint had petitioned the FDA, saying that the drugs were safe enough to be switched to over-the-counter status. If the FDA switches the drugs' status, the insurer could save about $45 million per year, the Post reports. The drugs cost between $60 and $90 for a one-month supply. The recommendation "represents a setback for the pharmaceutical industry," which opposes the switch and has threatened to sue the FDA if it follows the panel's recommendation (Connolly, Washington Post, 5/12).
During a hearing Friday, Schering-Plough Vice President Robert Spiegel, said, "Insurance companies see a physician visit as a cost item. We see it as an essential part of health care" (Recer, AP/USA Today, 5/4). Additional research is needed before the FDA determines that patients can "accurately diagnose and treat allergies without a doctor's input," drug company representatives added. Francois Nader, senior vice president of medical and regulatory affairs for Aventis SA, said that switching the medications to over-the-counter status is "inappropriate, unnecessary and potentially adverse" to public safety. Pfizer Corp. did not participate in the hearing (Washington Post, 5/12). Critics of switching the drugs' status maintain that symptoms associated with allergies actually could be asthma, the New York Times reports. But the drugs' manufacturers were "unable to produce data showing that this confusion had caused widespread problems with the many nonprescription allergy drugs already in stores." In addition, drug company officials "found it difficult to argue that their products were not safe, with or without a prescription" (Freudenheim, New York Times, 5/12). During the hearing, Robert Seidman, chief pharmacist for WellPoint, noted that the drugs are available over-the-counter in Canada, where there have been no problems (Washington Post, 5/12). FDA officials said that the agency already has ruled that allergies can be diagnosed and treated without a doctor and antihistamines can be available without a prescription, the Wall Street Journal reports (Lueck/Harris, Wall Street Journal, 5/14). The drug companies also argued that making the drugs available over-the-counter would cut prices and thus, "hurt future drug development." Bert Spilker, senior vice president of the Pharmaceutical Research and Manufacturers Association, said that if the FDA agrees with the panel, the move would "chill many areas of research and development." But Seidman said, "These companies know when the drugs are made available over the counter they will have to price them comparatively. They are attempting to instill a significant amount of fear." Last year, the three drugs generated $4.7 billion in sales (Washington Post, 5/12).
The FDA has never switched a drug to over-the-counter status on the recommendation of a third-party petitioner or without the cooperation of the drug's maker, the Journal reports. If the agency does follow the panel's recommendation, it "faces a number of hurdles," including questions about labeling and future court challenges. In addition, such a decision would set a precedent, prompting other insurers and third parties to petition for switches of other drugs (Wall Street Journal, 5/14). Spilker said, "If the FDA agrees to these switches, the changes discussed today will be the tip of the iceberg" (Washington Post, 5/12). But many analysts said they doubted the FDA possesses the legal authority to force the companies to switch the drugs' status, adding that the drugs' makers would likely take the case to court. Stephen Shondelmeyer, an economist at the University of Minnesota, said, "The law says the FDA should give preference to making drugs over-the-counter products if they can be shown to be safe and appropriately used. But it has never been implemented that way. Selling over the counter has always been left to the discretion of the drug companies. ... There are a lot of land mines in the politics of this" (New York Times, 5/12).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.