Senate should pass generic-drug bill, defeat malpractice amendment


Tuesday, July 30, 2002

Senate should pass generic-drug bill, defeat malpractice amendment

WASHINGTON, DC – Consumers Union, the nonprofit publisher of Consumer Reports, today urged the Senate to pass a bill to help make generic versions of brand-name drugs more available to consumers, citing a new government report on how brand-name companies manipulate the law in order to keep generics off the shelves.
The consumer organization also urged senators to defeat a medical-malpractice amendment to the bill aimed at limiting the liability of product manufacturers, insurance companies, and medical providers.
Janell Mayo Duncan, legislative counsel for Consumers Union, said a long-awaited report released today by the Federal Trade Commission (FTC) reveals how brand-name drug makers block the sale of generics by taking advantage of legal loopholes in the Hatch-Waxman drug-patent law.
The FTC said Congress should close two loopholes in the law. The first is a provision that lets a brand-name drug maker delay generic competition for 30 months by filing a new patent on a drug it is currently selling. The other loophole deals with the six-month period of exclusive selling rights given the first generic competitor to certain drugs.
“This report confirms what generic drug makers and consumer groups have been arguing for years,” said Duncan. “Brand-name drug companies have abused the patent law in order to avoid competition from generics. This report shines a spotlight on how easy it is for brand-name companies to force delays in bringing generics to market. Consumers could be saving billions of dollars every year on prescription drugs if they could only find generic versions. But that’s never going to happen unless Congress steps in and stops the delay tactics of the branded-drug makers.
“This bill would fill the loopholes cited by the FTC. It would also establish that generic drug makers have the right to challenge frivolous delays in court,” Duncan said.
Meanwhile, senators prepared to vote this afternoon on a controversial amendment offered by Sen. Mitch McConnell (Ky.) to limit a number of medical-related liability actions.
“This amendment is much more extensive than a simple medical malpractice amendment,” said Susanna Montezemelo, the Esther Peterson fellow at Consumers Union. “It also limits product liability suits related to prescription drugs and medical devices, as well as any liability actions related to HMOs, hospitals, and other medical care facilities. The proposal is unjust and unreasonable. The amendment attacks the rights of victims of defective and dangerous products, victims of medical malpractice, and victims of HMO denial of care. The amendment’s proponents have made dubious claims that it is necessary because of a ‘crisis’ in medical malpractice insurance. In fact, the so-called ‘crisis’ is indicative of the cyclical nature of medical malpractice insurance and problems with the insurance underwriting system, and this amendment goes much further than just limiting medical malpractice. The Senate should reject this attempt to undermine the product liability system.”
For more information contact: David Butler – (202) 462-6262