- The Washington Times - Tuesday, May 21, 2002

Two of the Senate's more talented grandstanders, Chuck Schumer of New York and John McCain of Arizona, are sponsoring a bill, nicely marketed as the "Greater Access to Affordable Pharmaceuticals Act," to speed approval of generic drugs by the U.S. Food and Drug Administration (FDA). Unfortunately, the Schumer-McCain legislation appears to be the product of spur-of-the moment politicking.

The bill has four main components: It would make it significantly harder for pharmaceutical companies, which spend an average $800 million to bring a new drug to market, to sue makers of generic or so-called "copycat" drugs that infringe on their patents. Second, it would water down current standards to allow the FDA to approve a wide range of generic drugs that are currently not eligible for approval because they are not considered duplicates of innovator drugs. Next, it would set up new roadblocks to deter whistle-blowers from providing the FDA with scientific information about the safety and efficacy of candidates for generic status. Lastly, it would tilt the current system for approving generic drugs in favor of generic drug makers in a way that would result in unnecessary litigation that would drive-up prices and keep many legitimate drugs off the market for a six-month period.

Patient safety surely would suffer grievously under a Schumer-McCain proposal to weaken existing law and allow the FDA to require only "limited confirmatory tests" on generic drugs. This would allow the FDA to approve generic drugs that differ somewhat from the innovator drug because the testing would purportedly show that the differences do not matter. Schumer-McCain also would cripple effective remedies for patent infringement, a potentially serious threat to future efforts to develop new drugs.

The Naderite group Public Citizen has lauded Schumer-McCain as "much-needed legislation" that will "make it harder for the major drug companies to use legal tricks to deny consumers the ability to purchase more affordable generic drugs." Characterizing pharmaceutical companies as "greedy" and purveyors of generic "copycats" as public-spirited businesses in need of federal protection is either naive or demagogic. Neither is a good basis for public policy.


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