Washington Editor

WASHINGTON Pharmaceutical companies that have used loopholes in the generic drug act to extend patent rights have caught the unenviable attention of Capitol Hill.

In particular, Sens. Chuck Schumer (D-N.Y.) and John McCain (R-Ariz.) are reportedly rallying support for “Greater Access to Pharmaceuticals” legislation introduced by the two last year aimed at reforming the Hatch-Waxman Act of 1984, the bill that created the generic drug industry. (Hatch-Waxman currently does not include biologics.)

In his testimony before the Senate Commerce Committee last week, Schumer said, “In the world of the drug industry right now, the brand companies are extending their monopolies to the detriment of consumers. There are a number of loopholes in the patent laws, which drug companies use every day to block their low-cost competitors from breaking into the marketplace.”

The McCain-Schumer legislation (S.812) would close some of the loopholes that have enabled pharmaceutical companies to extend their exclusive patents that have ultimately cost state governments, seniors and businesses million of dollars in prescription drugs, Jeanne Shaheen, governor of New Hampshire, said when she testified before the Senate Commerce Committee.

She cited the example of London-based AstraZeneca plc’s widely prescribed heartburn/acid reflux product called Prilosec. “A one-month supply of Prilosec costs a senior $152 at a drugstore in Henniker, N.H. It’s now been seven months since the patent on Prilosec expired, but there’s no generic on the market because AstraZeneca followed the now all too common strategy of brand-name manufacturers it sued its generic competitor, triggering an automatic 30-month stay on the FDA’s approval of the generic,” Shaheen told the Commerce Committee.

While Schumer and Shaheen see the issue one way, the pharmaceutical industry clearly has another view.

Jeff Trewhitt, spokesman for Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA), told BioWorld Today that his group adamantly opposes the McCain-Schumer legislation because it would poke holes in Hatch-Waxman, which set a balance between incentives for the brand-name or innovative industry, and the generic industry. “We think by and large that balance has worked pretty well over the past 18 years, and McCain-Schumer would eliminate that balance and put the distinctive tilt of the law toward the generic industry at the expense of the brand-name companies.” He said the pharmaceutical industry is confused by allegations that it is attempting to block development of generics.

Indeed, Trewhitt said in 1984 only 19 percent of the pharmaceutical marketplace was represented by generics. Today, 49 percent, or 8,000 drugs, are generics.

“If you look at those, well over 8,000 generic drugs have been approved since the law was passed. In 94 percent of those cases there was a smooth transition from brand name to generic with no patent dispute,” he said. “Hatch-Waxman provides a very unique situation for generics. This is the only industry in the U.S. where the generic company can do all the development and testing well before the innovator’s patent has expired, so that when it finally does expire, the next day the generic product is on the market. The pharmaceutical industry is the only industry in the U.S. where this is allowed.”

Trewhitt said there’s been a concerted effort in Washington over the past few weeks to breathe some life back into McCain-Schumer. “It was introduced last year and for a long period of time it went nowhere. Now, its supporters are trying to get it moving because it has not been moving. We feel it should stay right where it is and we are fighting tooth and nail against it.”

McCain-Schumer doesn’t really impact biologics. In fact, Steve Lawton, vice president for regulatory affairs and general counsel for the Washington-based Biotechnology Industry Organization, told BioWorld Today that his group has no position on the legislation. “It is largely designed to change the way in which the law has been implemented,” he said.

Sen. Edward Kennedy (D-Mass.) is expected to conduct a meeting this week on the McCain-Schumer legislation.