Legislators vow speedier OK's of biotech generics

WASHINGTON -- Some influential members of Congress are renewing their pledge to help speed generic versions of the world's most expensive drugs to market.

Representative Henry Waxman and Senator Orrin Hatch , in comments before the Generic Pharmaceutical Association , stressed the need for legislation that balance s the desires of generic drug makers against the needs of brand-name manufacturers who shoulder staggering drug development costs. The pair worked together in the past to sponsor landmark legislation that made other generic drugs available to consumers.

This time, however, the legislators are working at different speeds.

Waxman, Democrat of California , said Tuesday that he plans to introduce a bill to prod the Food and Drug Administration into action.

The generic drug industry is awaiting long-overdue FDA guidelines for manufacturers to follow to produce generic versions of biotechnology blockbusters, such as insulin , which are based on living organisms.

Hatch, Republican of Utah , said yesterday that the issue is too important to try to pass before the Senate recess, expected at the end of next week .

``There's no question we can't do much in this Congress," he said. ``I look forward to working with [Waxman], if we can do a balanced approach -- because nothing else is going to pass."

Hatch said that because biologic drugs are so expensive, Congress needs to help speed up their approval so manufacturers can start recouping their investments earlier.

The FDA review process for other important drugs -- such as treatments for AIDS and cancer -- has already been accelerated, financed by user fees paid by the drug industry.

The FDA approves generic versions of drugs once the patents for brand-name products expire. But complex biologic drugs go through a different approval process.

The federal agency has approved a generic version of one biotech product: Novartis AG's Omnitrope , which treats children and adults with growth disorders . But Omnitrope is less complicated than most other biologics.

Some 60 percent of prescriptions dispensed in the first six months of this year to beneficiaries covered by Medicare Part D were generics, saving taxpayers millions, said Dr. Mark McClellan , head of the Centers for Medicare and Medicaid Services .

McClellan said he is willing to wait for generic versions of more complex biologics until the FDA is better able to scientifically demonstrate they are safe, effective, and equivalent to brand-name versions.

``How do you provide sufficient support for developing that science, so people can confidently use generic versions of biologic drugs?" he said. ``That is a question that has to be answered first."

But companies like Barr Pharmaceuticals Inc. are pushing for faster FDA action on biologics. Barr this month bid $2.5 billion to purchase an Eastern European drug maker that is one of the few in the world that can manufacture generic biologics.

``We are also working with Congress on legislation that would open this $33 billion-a-year market for generic biopharmaceutical competition and are encouraged by the increased interest in introducing such legislation," said Carol Cox , a Barr spokeswoman.

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