By closing loopholes pharmaceutical companies use to delay competition with generic drugs, Congress could help Americans save billions of dollars a year.

With national security and re-election on its mind, Congress may not get around to providing retirees with a prescription drug benefit this year. So that means many Americans will have to choose between filling a prescription and taking care of other basic needs. One bill pending in the Senate, however, would give millions of people (both old and young) a break on the price of some commonly prescribed drugs.

Sens. Chuck Schumer, D-N.Y., and John McCain, R-Ariz., have sponsored a bill that would close legal loopholes drug companies use to delay competition from cheaper generic drugs. If the bill can overcome heavy pharmaceutical-industry lobbying, it could save Americans billions of dollars a year.

A patent on a brand-name drug lasts 20 years, after which the market is supposed to be open to generic versions of the medicine. Such protection gives a drug company enough time to make a generous profit plus recoup the cost of research and development. But some companies have been able to manipulate the current law to prolong their control and to keep the price of the drug artificially high.

That's what happened with the blood-pressure medicine Tiazac, according to Public Citizen, a consumer-protection group. A generic version was scheduled to be available in 1998, but Tiazac's maker, Biovail, sued, claiming a violation of its patent. Under the law, that triggered an automatic 30-month stay on the release of the generic rival. Biovail lost the suit, but that still didn't lead to competition because the company listed a new patent on an extended-release version of Tiazac. Even though Biovail didn't make that version of the drug, it held off competitors until this year, when the U.S. Food and Drug Administration got the company to stop blocking a generic competitor.

The delay on just that one drug cost consumers millions of dollars, but the savings potential is much greater. Schumer and McCain told Times staff writer Sara Fritz that such tactics to stall competition on five popular brand-name drugs -- Paxil, Wellbutrin, Prilosec, Tiazac and Neurontrin -- have cost consumers more than $7-billion.

What the bill (S 812) would do is eliminate the automatic 30-month stay, which is given even when a frivolous suit is filed. Instead, a company would have to first prove to a judge that it deserves protection against a generic competitor. The bill would also prohibit a current practice in which a drug company grants one competitor exclusivity for 180 days as long as the generic drug isn't aggressively marketed.

Makers of brand-name drugs use another underhanded method to delay competition. Anyone can file a petition with the FDA to stop a generic drug from being marketed. That delays the process until the agency can consider the complaint, and drug companies have secretly initiated such filings. The Schumer-McCain bill would require petitioners to disclose if they are acting on behalf of a company.

The pharmaceutical industry is one of the most formidable lobbying groups in Washington and has successfully stopped reform efforts in the past. But the Schumer-McCain bill has attracted impressive support, such as employers Ford Motor Co. and General Motors and health care companies Blue Cross Blue Shield and Kaiser Permanente.

The bill might be the last hope this year for Americans to get any relief from the high cost of prescription drugs. It deserves a hearing in Congress.

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