Shaheen Takes Pharmaceutical Drug Message to the Capitol
WASHINGTON, April 23–Governor Jeanne Shaheen has taken her fight to Congress to change a law that limits competition among prescription drug manufacturers.
If the manufacturers of 15 brand-named drugs whose patents expire over the next two years face timely competition, New Hampshire could save $2.5 million each year in prescription drug costs by 2005, Shaheen testified before the Senate Commerce, Science and Transportation Committee on Tuesday.
“In New Hampshire, $2.5 million would make a big difference for our taxpayers and the children, seniors and other vulnerable citizens who depend on state services,” she said.
A controversial section of the 1984 Hatch-Waxman Act allows brand-name pharmaceutical companies to stall competition from generic manufacturers by claiming patent infringement, which automatically grants a 30-month stay by the Food and Drug Administration (FDA).
These loopholes “are forcing state governments, seniors and businesses to spend hundreds of millions of dollars unnecessarily on brand-name prescription drugs,” Shaheen said.
She said the Granite State spent $88 million in the last fiscal year on prescription drugs, more than twice the $41.7 million it spent in 1996.
Sitting next to Timothy Muris, the chairman of the Federal Trade Commission (FTC), Shaheen told the committee that she and other governors needed their help.
“The skyrocketing cost of prescription drugs is making it increasingly difficult for governors to provide high-quality Medicaid coverage to children, seniors and people with disabilities – without breaking the backs of taxpayers,” she said in the overfilled hearing room flanked with black-and-white photos of former committee chairmen.
In written testimony, Shaheen said she wants to close loopholes in Hatch-Waxman that allow companies like AstraZeneca to use a section of the law to stall competitors from going to market with generic alternatives. AstraZeneca’s patent on the popular drug Prilosec expired, she said, but it has not faced competition from a generic version of the drug because it claimed patent infringement and was granted an automatic 30-month stay on FDA approval of a generic version of the anti-heartburn medication.
The FTC, Muris said, has taken antitrust enforcement actions against drug manufacturers that have misused Hatch-Waxman.
Other testimony in favor of reforms to Hatch-Waxman came from Tim Fuller, the executive director of the Gray Panthers, an advocacy group on social issues, and Kathleen Jaeger, the president and CEO of the Generic Pharmaceutical Association. All witnesses except Shaheen represented national organizations.
Sen. John McCain (R-AZ), the senior minority member of the committee, has introduced legislation that would eliminate the 30-month stay provision. He and Sen. Charles E. Schumer (D-NY) announced their Greater Access to Affordable Pharmaceuticals Act on May 1, 2001.
During a conference call after the hearing, Shaheen said that when the New England governors met in Washington in February they passed a resolution to urge Congress to close loopholes in Hatch-Waxman
“Medicaid was the strongest rising part of the budget in most states,” she said. “What’s driving those costs is the cost of prescription drugs.ยท This isn’t the only answer, but it is one of the ways we can address it.”
Drug companies contend that changing Hatch-Waxman will result in less innovation, research and development of new drugs.
Two witnesses testified against changing the law.
Shelbie Oppenheimer of the ALS Association testified that advances brought about by prescription drugs have aided her battle with Amyotrophic Lateral Sclerosis.
Dr. Greg Glover, who spoke on behalf of the Pharmaceutical Research and Manufacturers of America, said that people who want to change Hatch-Waxman have not met the burden of showing why a change is needed.
Glover pointed out that generic drug companies’ share half of the prescription-drug market, up from 20 percent before the law was enacted, and that generic manufactures no longer have to wait three to five years after a brand name drug’s patent expires to introduce their no-name alternatives.
“As a result of the Hatch-Waxman Act, generic manufacturers are able to avoid the huge cost, estimated at over $800 million on average, of discovering and developing a new drug,” Glover said.
Julie Teer, the communications director for the New Hampshire Republican State Committee, said that Shaheen “should realize that her actions would put bureaucrats in charge of medicine instead of doctors. We need to make sure life-saving innovation is not stifled.”
Published in The Union Leader, in Manchester, New Hampshire
