Dose of relief

WASHINGTON -- They're not sexy. They're not the darlings of multimillion-dollar advertising campaigns. But, generic drugs account for more than half of prescriptions written and, with the advent of the Medicare prescription drug benefit, members of Congress want to tap generics' savings potential.

Analysts who follow generics say the next few years will usher in a historic shift as these drugs dramatically transform the pharmaceutical landscape. Such megahits as cholesterol-lowering Lipitor and Zocor -- the nation's two best-selling drugs last year -- the depression treatment Zoloft, and the sleep remedy Ambien are scheduled to lose patent protection, which allows rivals to sell generic versions.

''It is the golden age of the generic business," said Doug Long, vice president of industry relations at IMS Health Inc., a Fairfield, Conn., healthcare-information company.

The branded drugs scheduled to lose patent protection in the next three years would have generated an estimated $78 billion in revenue for their companies without the new generic competitors.

Generic drugs are identical to their brand-name counterparts and are their chemical equivalent. Generics, however, are cheaper because their manufacturers do not have to conduct years of clinical trials in humans to confirm

safety and efficacy, and their firms do not spend millions on marketing. While generics accounted for 56 percent of prescriptions dispensed, Americans spent $22.3 billion on them last year, compared with $229.5 billion for branded drugs, according to the Generic Pharmaceutical Association, the Washington trade group that represents generic manufacturers.

Some in Congress, alarmed at a backlog of 800 generic drug applications at the Food and Drug Administration and weak staffing in that department, have pressured it to accelerate approvals of generics. On Friday, Senator Herb Kohl offered an amendment to boost FDA funding by $20 million -- enough to process 160 generic applications.

''At a time when healthcare costs continue to rise at double-digit rates, it is critical that we address this backlog immediately," said Kohl, Democrat of Wisconsin.

And while European drug regulators issued guidelines for generic copies of biotechnology treatments and approved generic growth hormone Omnitrope, the FDA has delayed on the matter. A federal judge this month required the FDA to rule quickly on Novartis AG's application, filed in July 2003, to sell Omnitrope in the United States. The decision is key to whether biotechnology companies ever face generic competitors in this nation.

Analysts say the generics industry's coming-of-age coincides with key drivers of US drug sales: Graying Americans who live longer and who juggle a number of daily prescriptions; increased copayments for branded drugs; and a push at the city, state, and federal levels to slow the spiraling rise in healthcare costs.

Kathleen Jaeger, president of the Generic Pharmaceutical Association, called generic drugs the cornerstone of city, state, and federal policies to stretch scarce healthcare dollars.

''Generics are clearly part of the solution," Jaeger said.

If the nation's seniors replaced just 14 of the most popular brand-name drugs in their medicine chests with cheaper generics, Medicare would save $23 billion through 2010, pharmacy benefit managers said this month.

Already, an agency that provides benefits to about 266,000 Massachusetts employees and retirees shaved $3.94 million from its prescription drug bill in 2005 by asking its members to first use generics and by upping copayments if they use branded products, such as ulcer treatment Nexium.

The savings from generics is ''incredibly important," said Dolores Mitchell, executive director of the Massachusetts agency, Group Insurance Commission. ''The differentials are huge."

The FDA, on average, approves one new generic drug every day, Andrew von Eschenbach, the agency's acting commissioner, testified before Congress last month.

That trend continued with this month's expiration of Bristol-Myers Squibb Co.'s patent on Pravachol, a cholesterol-lowering drug with $1.3 million in sales in 2005, and a speedy move by Teva Pharmaceutical Industries Ltd. to sell a cheaper rival.

While drug company innovators say they can keep sales high, generics, especially later arrivals to a crowded field, dramatically slash costs.

When a branded product has a single generic competitor, the rival sells for 94 percent of the brand drug price. By the time nine generics vie against the branded innovator drug, prices plummet to 20 percent of the branded drug price tag, according to the FDA.

Analysts and the generics industry speculate that this pricing trend was behind an increase in petitions innovator drug companies filed with the FDA, posing complex questions that slow FDA approvals.

GlaxoSmithKline filed two such petitions with FDA that delayed by more than three months the introduction of a generic rival to its asthma spray, Flonase. Meanwhile, Flonase generated $3 million in sales per day.

''We can do the math," said the generic pharmaceutical group's Jaeger. ''That's a substantial amount of money Glaxo just generated to its bottom line."

Mary Anne Rhyne, a Glaxo spokeswoman, said the petitions were not a delaying tactic. Instead, they sought clarity from regulators that the generics would be held to the same standards as brand-name companies.

Like their branded rivals, generic companies have assembled supporters in key congressional committees with oversight over the FDA's budget.

Von Eschenbach faced dozens of questions from Congress about the agency's staggering generic drug application backlog and its long-delayed rule covering generic biologic drugs.

During a recent House hearing, he declined to say when the agency would publish guidelines on generic biotech drugs, due to the complexity of confirming that generics of treatments based on living organisms are equivalent to branded rivals. ''It's charting new territory, and we want to be certain that it's done appropriately and precisely," he testified.

During a recent Senate hearing, however, von Eschenbach said the agency has improved the way it processes generic drug applications. But as the FDA chips away at the application backlog, it is putting a higher priority on drug types with few generic competitors, he said. Generic applications for drug types with three or four generic rivals are lower priority.

Senator Robert Bennett called the plan ''prudent management," but the Republican of Utah added ''it would be helpful if the total number could come down and the total back log could shrink."

Diedtra Henderson can be reached at dhenderson@globe.com.