Plans made seven years ago by Sen. Orrin Hatch, R-Utah, to move more generic drugs into the marketplace have been thwarted by the Food and Drug Administration and others, Hatch said.
Speaking to the Drug Information Association and to FDA President David Kessler, Hatch said the FDA has been moving at a "sluggish pace" in approving important, low-cost generic drug products.Hatch said this slow pace does not comply to a law found in a bill he wrote and passed in 1984, which was designed to quickly infiltrate generic products into the marketplace while maintaining necessary safety and efficacy standards.
He said generic drugs are important because they generate a competitive environment in the pharmaceutical drug market.
"In 1986, 720 abbreviated new drug applications were approved. In 1990, only 60 were approved," Hatch said, adding that in the past month there were only four approved applications.
"Part of this slowdown, without question, comes from the FDA, who aggressively pursued a review of all currently marketed generic drugs," Hatch said.
He said while the FDA has done a good job of hunting down problems in the generic industry, its current lack of efficiency is going to cost taxpayers.
"Over the next five years, patents will expire on an estimated $10 billion worth of brand name drugs," he said.
"If the logjam in the approval process is not fixed, it is estimated that the annual price of these products alone will take nearly $2 billion more than it should from America's pockets."
Hatch - who said he supports the mission of the FDA completely - said change is necessary, and he feels a good way to get the FDA on its feet again is to follow suggestions made in a report from the Edwards Commission.