DURING THE 1940s and '50s, with the advent of "miracle drugs," manufacturers patented their wares so that only they could produce a particular product. But many of these drugs were costly, and unscrupulous firms began marketing drugs that were touted as "just like" what the doctor ordered - but cheaper. Regrettably, these drugs were cheaper not only in price, but also in quality - and the Food and Drug Administration stepped in with "anti-substitution" regulations to clean up what had become a shoddy practice. The FDA regulations saved countless thousands of people from illness and death in those days. But now that many of the drug patents have expired, politicians, health officials and consumer advocates are questioning the need for continuing the "anti-substitution" regulations.
We think the challenges have merit. Sen. Gaylord Nelson (D-Wis), chairman of the subcommittee on monopoly of the Senate Select Committee on Small Business, recently held hearings that revealed that "anti-substitution" now allows brand-name drugs to enjoy a substantial price advantage - even thought the identical drug can be purchased at considerable savings under its more technical generic name. The problem is complicated by the fact that many drug companies buy their goods from manufacturers who deal in generic products, then re-label them with brand names and sell them at higher prices.
A variety of arguments are advanced by the American Medical Association and others to convince the public that generic substituitions can be detrimental to your health. One is that, since only the doctors know precisely what should be given to a patient, taking away their ability to prescribe a specific drug will lead to confusion in drugstores - and damage to health throughout the country. What these opponents conveniently forget - and what was clearly brought out in the subcommittee hearings - is that use of generic drugs need not threaten the life of a patient. Several states have developed relatively simple procedures that physicians can use to indicate on the prescription whether generic drugs my be substituted; pharmacists are provided with a list of just which generic drug may be substituted for a particular brand name.
But the cost of prescription medication is also of growing concern. It is now possible to buy two identical drugs - which may well have started off as the same item in the manufacturing plant - at two widely differing prices; the one with the brand name may cost eight times as much as the generic drug. The price differentials involved become staggering when they are measured in terms of Medicaid and Medicare costs. The federal government alone is spending several hundred million dollars a year in extra costs because most physicians use brand names rather thean generic names - and most patients don't know enough about generic labeling to ask for it.
What's needed, we think, is a comprehensive - and objective - examination of the way in which drug manufacturers control drug pricing. Sen. Nelson's subcommittee has opened the door to the need for federal legislation that would eradicate the worst parts of the "anti-substitution" regulations while preserving patient safety. Brand-name prescription drugs might just be what the doctor ordered. But generic drugs may be just as effective for our health - and a lot more beneficial to our pocketbooks.