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News: Analysis & Commentary
Commentary: Lots of Drugs Should Stay behind the Counter
For all the current brouhaha over Medicare coverage of prescription drugs, you'd think it was the only battle being waged over the pharmaceutical industry in Washington these days. But just outside the Beltway, on June 28 and 29, the Food & Drug Administration will hold hearings to consider whether drugs for treating such serious conditions as high cholesterol, hypertension, and osteoporosis should be made available over the counter (OTC), instead of with a prescription from a doctor. If the FDA eventually gives the nod, there could be a flood of conversions. Already, drugmakers have begun pushing for such switches, with FDA hearings on the switch of two prescription drugs to OTC status scheduled for July.
However, when it comes to opening such floodgates, the agency should tread lightly. Many of the conditions that these drugs treat require close monitoring and supervision by a physician. If people aren't compelled to see their doctor, as happens when they need a prescription, many patients may start taking pills without making the extra effort to ensure their medicine is working correctly. Even more disturbing, such reduced doctor-patient interaction may lower the chances that doctors will spot other burgeoning health problems.LOW-COST RIVALS. Despite those risks, the FDA is coming under pressure from all sides to loosen restrictions on prescription drugs. Among the biggest backers are some drugmakers. According to Lehman Brothers Inc., over the next five years, drugs generating $43 billion in sales will see their U.S. patents expire. When that happens, cheaper generic versions often hit the market and quickly erode sales of the branded product. Selling the product over the counter can offset some of the sales erosion to generic manufacturers. Overall, Steve Francesco, publisher of the drug industry newsletter Switch, figures the FDA could receive conversion applications for drugs with some $20 billion in sales over the next three years. That's as much as the total value of U.S. OTC sales in 1999. Merck & Co., for one, has already filed an OTC application with the agency for Mevacor, its $600 million cholesterol-lowering drug, which has a patent that will expire next year.
At the same time, many insurers and HMOs would like to see more products sold without a prescription. That change would likely lower their costs, since many plans don't cover OTC purchases. Take Blue Cross of California. It filed a petition with the FDA in 1998 to force certain allergy drugs, including $2 billion-seller Claritin, to be made available over the counter. Claritin manufacturer Schering-Plough Corp. objects to the move, arguing that physicians should be involved in managing a patient's allergies. But most analysts say that Schering can squeeze out more profits by keeping the medication doctor-prescribed.
While Claritin may be a no-brainer for OTC sales, many other types of drugs the FDA will likely consider for OTC use pose greater risks. Cholesterol-lowering drugs are just one example. Doctors are encouraged to perform tests on patients starting prescriptions such as Mevacor because they can seriously impact liver function in some cases. Although that may be less of an issue at the low dose of Mevacor that Merck wants to make available over the counter, consumers may decide to up the dose themselves; they may figure they are better off lowering their cholesterol as much as possible. "There is a certain potential for abuse that exists," warns Wayne L. Pines, president of regulatory services at consulting firm APCO Worldwide Inc.
Nor are potential side effects the only troubling aspect to doing away with prescriptions for serious drugs. Consider birth control pills, which might seem a natural for OTC sale. Physicians warn that the need to get a prescription for birth control helps drive many women to their doctor's office for an annual Pap smear, a test that saves lives by yielding early detection of cervical cancer. "This could undermine the relationship between the patient and physician," argues Dr. Terrence L. Moore, a doctor in Denton, Texas. As with other cost-saving remedies, cutting physicians out of the loop may just be a prescription for disaster.By Amy Barrett; Philadelphia Bureau Chief Barrett Covers the Drug Industry.