FDA: Reviews OTC Status for Certain Prescriptions
An FDA panel will wrap up hearings today on whether to switch switching some prescription drugs to over-the-counter status, the Wall Street Journal reports. Some possible categories of drugs being considered for OTC status include allergy medicines, birth control pills and cholesterol-lowering drugs. Many doctors and consumer advocates oppose the move, arguing that people are less careful about taking OTC drugs, which could have serious side effects or cause problems if taken incorrectly. Michael Greene of the American College of Obstetricians and Gynecologists asked the FDA panel to "carefully review" potential OTC products for their effects on pregnant women and their fetuses. "Women are frequently reticent to take prescription drugs, but they take OTC drugs without thinking twice," he said. Sidney Wolfe, director of the consumer group Public Citizen, said that people's ability to take OTC medicines without seeing a doctor would "alter the ratio of benefit to risk," since they might take unnecessary drugs or inappropriate dosages. A National Consumers League survey, presented to the FDA panel yesterday, backs up these critics' fears, the Wall Street Journal reports. Fourteen percent of those surveyed said they take more than the recommended dose of OTC drugs most or all of the time, and 16% said there was "no problem" with interactions between their current prescription drugs and OTC drugs (Lueck, 6/29).
Prescription for Disaster?
Despite the potential risks, a Business Week commentary reports that drugmakers and insurers are putting pressure on the FDA to "loosen restrictions." In the next five years, patents for many drugs will expire. Profits for the makers of these drugs will sink as generic competitors hit the market, but by switching a drug to OTC status, companies can offset some of their losses. HMOs, which usually do not cover the cost of OTC drugs for their patients, also want more OTC drugs available since it would lower their costs. Blue Cross of California, for example, filed a petition with the FDA in 1998 asking that certain allergy drugs, such as Schering-Plough's Claritin, be moved to OTC status. Business Week warns that, although "Claritin may be a no-brainer," other drugs should not be available OTC. Switching birth control pills, for example, may jeopardize women's reproductive health. Some providers note that prescription birth control pills require women to see a doctor and receive an annual Pap smear, which "saves lives" by screening for cervical cancer. Dr. Terrence Moore says that a switch for oral contraceptives "could undermine the relationship between the patient and physician." Business Week concludes: "As with other cost-saving remedies, cutting physicians out of the loop may just be a prescription for disaster" (Barrett, 7/3).