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Bush Seeks to Speed Low - Cost Generic Drug Access

REUTERS, October 21, 2002

The measures seek to limit the ability of major drug companies to prolong patent protections on brand name drugs. Bush announced the regulations at a White House Rose Garden ceremony in which he emphasized the benefit for senior citizens -- a powerful voting bloc with deep concerns over drug costs.

``By this action we will reduce the cost of prescription drugs in America by billions of dollars and ease the financial burden for many citizens, especially our seniors,'' Bush said.

Key Democrats said Bush's proposed rules fell short of the changes sought by party lawmakers, including a broader generic-drug bill opposed by the administration and prescription drug coverage for Medicare patients.

Sen. Charles Schumer of New York, co-author of a Senate-passed measure on generic drugs which failed to pass in the Republican-controlled House of Representatives, said, ``I worry that this is an election-day conversion.''

Schumer's office said the Bush proposals lacked a way to enforce the restrictions against frivolous new patents and contained loopholes that would let brand name drug makers continue to delay generics from coming to market.

The measures would cut prescription drug costs by more than $3 billion a year in the United States, the White House said.

Total U.S. retail spending on prescription drugs reached $154.5 billion in 2001, according to the National Institute for Health Care Management. Generic drugs comprise about half of all prescriptions filled in the United States.

U.S. officials said the average generic drug prescription costs less than $17, compared with $72 for a brand name drug protected by patents.

The announcement comes ahead of Nov. 5 congressional elections in which Democrats have sought to focus attention on domestic issues, including the affordability of prescription drugs. Major drug makers have fought Democratic efforts to accelerate the approval and marketing of generic drugs.

An administration official said there was ``very little if any'' political motive behind the announcement. White House spokesman Ari Fleischer said Bush had waited to see whether the U.S. Congress would complete legislation on the issue, and acted after it became apparent there would be no bill.

The Pharmaceutical Research and Manufacturers of America, the lobbying group for brand-name drug makers, was still studying the Bush proposal. ``This is a complex matter and we need some time to look at it,'' spokesman Jeff Trewhitt said.

A generic drug makers group welcomed the proposal as a ``wonderful first step'' that would limit abuses.

BROADER BILL

The Bush proposals implement some of the recommendations made this summer by the Federal Trade Commission, which concluded the law governing competition between generic and brand name drugs created a ``potential for abuse.''

The new regulation would seek to limit a drug patent holder's ability to draw out the process for bringing a generic drug to market though multiple challenges. It would limit patent holders to one automatic 30-month stay of a generic drug application while a challenge is contested.

The FTC report found eight cases between 1992 and 2000 in which a drug company was believed to use the challenge process to simply draw out approval of a new generic drug.

Administration officials said the practice threatened to accelerate as patents expire on several major drugs. These include anti-allergy drugs Flonase, made by GlaxoSmithKline PLC GSK.L, Schering-Plough Corp's Claritin, depression treatments Paxil, by GlaxoSmithKline and Pfizer Inc's Zoloft, and Bayer AG's antibiotic Cipro.

The new regulation also would restrict a drug company's ability to file what officials called ``frivolous'' new patents for an existing drug. New patents could no longer be obtained for new packaging methods, for intermediate forms of the drug, or for ``metabolites'' -- substances the drug changes into inside the body.

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