- The Washington Times - Monday, October 21, 2002

The Bush administration will seek to bring cheaper prescription drugs to market more quickly by blocking pharmaceutical companies from filing multiple patent-protection lawsuits that can stall generic drugs for years, administration officials said late yesterday.
Brand-name drug manufacturers sometimes file lawsuits against generic drug makers poised to put less-expensive competitors on the shelves. The lawsuits invoke the 1984 Hatch-Waxman Act, which is meant to promote competition in the drug industry but also gives the brand-name makers up to 30 months of additional patent protection while litigation proceeds.
The Federal Trade Commission found earlier this year that big pharmaceuticals were using this tactic increasingly to fend off competition and keep generics out of consumers' hands, sometimes for years.
Generic drugs usually face no such patent challenge, but in some instances the brand-name makers use the 30-month shield more than once.
The drug manufacturers sometimes build their patent lawsuits around what an administration official calls "frivolous" issues such as packaging claims.
President Bush is to announce early today that the administration will move to limit the brand-name manufacturers to a single, 30-month stay per drug. The administration also was moving to tighten requirements and increase disclosure mandates for drug patent listings.
Prescription drugs are a hot-button issue in this year's elections. Looking to squeeze maximum political gain out of the move, the White House told reporters of its move in a conference call last night, ensuring two days worth of headlines.
The administration will announce its intentions early this week in the Federal Register, open the plan to public comment for 60 days and move to finalize the rule after that, said a senior administration official.
The White House said about half of all prescriptions are filled with generic drugs, which cost about a third as much as brand-name drugs.
The administration estimated the change would save $3 billion in drug costs per year. It said the rule would ease the burden on employers who contribute to prescription drug coverage, and would make it easier for the federal government to provide a prescription drug benefit as part of Medicare.
The Generic Pharmaceutical Association said it had not seen the specifics of Mr. Bush's move but had urged the administration to move in this direction. "The administration understands the need to address the system abuses that have delayed affordable pharmaceuticals to consumers," said Kathleen D. Jaeger, the association's president.

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