By

Washington

Insurance groups, businesses and consumers are all praising legislation approved last week by the Senate aimed at improving access to generic drugs.

The legislation, S. 812, allows the Food and Drug Administration to accelerate approval for generic drug applications. It also eases the rules by which a generic drug is listed as a “bioequivalent” to a listed, non-generic drug.

The bill, sponsored by Sen. Charles Schumer, D-N.Y., was approved by the Senate on July 17 by unanimous consent.

The Blue CrossBlue Shield Association, Washington, issued a statement supporting the legislation, calling it a “critical first step in our nations efforts to rein in rising health care costs.”

S. 812, Blue Cross says, would increase the number of health care choices available to consumers, with the potential for saving them billions of dollars on prescription drug costs over the next few years.

While Blue Cross says it has been actively encouraging the wider use of generic drugs, these efforts alone are not enough.

The efforts will be greatly enhanced, Blue Cross says, by Congressional efforts to open the door to broader market entry for generic drugs.

Janell Mayo Duncan, legislative counsel for Consumers Union, Washington, also praised the legislation.

In particular, she praises the bill for containing provisions that give generic drug firms a new right of action to challenge “frivolous” patents filed by brand name drug companies.

“As opponents of the bill look for ways to scale it back, we firmly believe that the cause of action provision must be preserved,” Duncan says.

“It is a critical part of reforming the system and putting a stop to the delays that brand-name companies use to keep generics off the shelves,” she adds.

The Coalition for a Competitive Pharmaceutical Market, an organization of large employers, generic drug manufacturers and labor unions, also praised the bill.

Brand-name drug manufacturers oppose the legislation, arguing it would create a disincentive for research and development.


Reproduced from National Underwriter Life & Health/Financial Services Edition, July 22, 2002. Copyright 2002 by The National Underwriter Company in the serial publication. All rights reserved.Copyright in this article as an independent work may be held by the author.