FDA: Launches Campaign In Defense Of Generics
"[F]rustrated by a battle over a generic version of the popular blood thinner Coumadin," the Food and Drug Administration has taken the "unusual" step of contacting 200 medical groups to defend generic drugs. In the letter, which also was sent to "every state board of pharmacy, the FDA insisted [that] questions about generic drug equality are misplaced" (AP/Washington Post, 2/4). The Newark Star-Ledger reports that the FDA called "the ongoing lobbying effort aimed at getting states to restrict use of generic drugs ... misguided." FDA Associate Commissioner Dr. Stuart Nightingale wrote, "In approving a generic drug product, the FDA requires rigorous tests and procedures to assure that the generic drug is interchangeable with the brand-name drug under all approved indications and conditions of use. ... Additional clinical tests or examinations by the health care provider are not needed when a generic drug product is substituted for the brand-name product."
FDA Deputy Associate Commissioner Tom McGinnis said the letter was sent to state medical groups "to answer numerous inquiries from state officials who have been subjected to a lobbying campaign by brand-name drug makers" maintaining that switching generic drugs with their brand-name counterparts could compromise patients' health (Cohen, 2/4). "When the agency approves a generic product, we stand behind the interchangeability of that product, [which] should produce the exact same results you'd expect from the brand-name product," McGinnis said.
The AP/Washington Post reports that "DuPont Merck is waging a fierce battle to protect its $500 million-a-year Coumadin market from Barr Laboratories' new, cheaper generic version known as warfarin." The pharmaceutical company has launched a campaign "to persuade states to forbid pharmacies to substitute" any drugs that require exact dosage for effectiveness "with a cheaper generic duplicate unless it is approved by physician and patient." So far, North Carolina, Texas and Virginia have these rules on their books; laws are pending in California, Massachusetts, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma and Tennessee. DuPont spokesperson Susan Pritchard said, "All we're asking for is informed consent of a switch. We don't understand why people would be opposed to knowing which product you're going to be on" (2/4).