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Consumer Reports

Generic drugs get to consumers quicker under new FDA rules | (KRT) President Bush announced new rules Thursday that will speed the availability of generic drugs to consumers by limiting drug companies' ability to block them from the marketplace.

Under the new rules, companies that create brand-name drugs will be limited to a single 30-month delay of federal approval for competitors' applications to produce generic versions of those drugs.

Drug companies now get automatic 30-month stays by the Food and Drug Administration each time they file a copyright-infringement suit against a would-be generic competitor. That can mean lengthy delays before generic drugs are allowed to enter the marketplace.

Drug companies spend millions developing new medicines, and the federal government gives them patent protection for their inventions to encourage and reward their enterprise. The FDA can approve a generic drug once the patent protection on a brand-name counterpart expires or when a court rules that the generic won't infringe on the innovator's patent.

Bush said that while it was good to protect innovative drug makers "for a while," the new rules will ensure that "the initial manufacturer of a drug will not be allowed to use the legal process for endless delay, which hurts our consumers in America."

Savings to individuals from the new rules could be significant. According to the administration, the average cost of a month's supply of a brand-name prescription is $72, compared with $17 for a generic version.

The new rules take effect Aug. 18. They also will limit drug-makers' ability to block competitors by claiming patent protection on features such as packaging that aren't related to the drug's effectiveness. They tighten rules on patent applications and revise the review process for determining a drug's safety and effectiveness.

"By taking these actions, we will bring generic drugs to the market much more quickly, in some cases years earlier," said Bush, who announced the plan at a hospital in New Britain, Conn. The measures will save consumers some $3.5 billion a year, he said.

The FDA proposed the new rule ending multiple 30-month stays last year.

On Wednesday, a Senate committee approved legislation that also would speed generic drugs to market, and would address a broader variety of issues that slow the process. The legislation would seek to keep brand-name drug-makers from paying their generic competitors to stay out of the market, and would limit the number of patents that companies could register for drugs.

Critics of the existing FDA rules say Thursday's changes are largely cosmetic, failing to address the broader variety of abuses the Senate legislation would resolve.

Ron Pollack, the executive director of Families USA, a consumer health care-advocacy group, said the new regulations were part of an administration effort to weaken congressional efforts to pass stronger legislation on generic drugs.

"The (FDA) regulations are a pale substitute," Pollack said. He said the pending Senate legislation would provide considerably stronger consumer protections. "This is part of an effort to derail protections that would enable seniors and others to get generics much more quickly."

Drug manufacturers were even less enthusiastic.

"Current law works well, with just 10 cents out of the health-care dollar funding all the medicines patients now use, and research on new medicines," said Alan Holmer, the president of the Pharmaceutical Research and Manufacturers of America, an industry trade group. "The new FDA rule is lengthy and complex, and we are studying it closely. We need to be sure that the rule clarifies current law in a way that supports continued development of new and better medicines that patients need."

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© 2003, Distributed by Knight Ridder/Tribune Information Services