Byline: THE WASHINGTON TIMES
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. …