Wall Street Journal Looks at FDA’s Plans To Make More Allergy Medications Available OTC

The Wall Street Journal on May 6 examines a plan by the FDA to shift the prescription allergy medications Clarinex, manufactured by Schering-Plough; Zyrtec, manufactured by Pfizer; and Allegra, manufactured by Aventis, to over-the-counter status, part of an effort to reduce prescription drug costs that could "produce friction" with the pharmaceutical industry. FDA Commissioner Mark McClellan has said that the plan remains under "active consideration" at the agency and would result in "a substantial decrease in price and a substantial decrease in use" of the three allergy medications. Pharmaceutical companies maintain that the plan would violate their patent rights and "squelch innovation," the Journal reports. The patent on Allegra lasts until 2011, and the patent on Zyrtec lasts until 2007. However, under federal law, pharmaceutical companies should market prescription drugs OTC unless they pose a safety risk when used without direction from a physician; an FDA advisory committee decided in 2001 that Allegra and Zyrtec were safe for OTC use. According to the Journal, however, the FDA plan to shift the allergy medications to OTC status would likely face a number of legal and scientific issues. The FDA would face legal challenges to the plan from pharmaceutical companies and also would have to prove the safety of the medications for OTC use, which could require additional studies. In addition to allergy medications, the FDA has considered plans to shift prescription heartburn medications, birth-control pills and emergency contraceptives to OTC status (Abboud, Wall Street Journal, 5/6). In related news, the New York Times on May 6 examines the FDA's drug approval process (Pollack, New York Times, 5/6).