Insurers Praise Bushs Generic Drug Proposal

Karen Ignagni, president of the American Association of Health Plans, Washington, adds that according to some estimates, the proposed rules could lead to significant consumer savings.

But Ron Pollack, executive director of Families USA, says that while the proposal is welcome, it is much weaker than legislation pending on Capitol Hill that makes it more difficult for brand name drug manufacturers to file frivolous new patents aimed at preventing generics from reaching the market.

Under the proposed rule, which the Bush administration says could save consumers $3 billion a year on prescription drug costs, the generic drug approval process would be accelerated.

Specifically, drug manufacturers would be allowed to file only one 30-month stay per generic drug application to resolve allegations that a generic drug maker is infringing on a patent.

The administration says 30 months is enough time to resolve cases of patent infringement. Multiple 30 month stays, which have led to delays in generic drug approval, would not be permitted.

In addition, the new proposal would make certain procedural changes in a Food and Drug Administration listing of drug patents aimed at reducing the opportunity to list inappropriate patents.

Reproduced from National Underwriter Life & Health/Financial Services Edition, October 28, 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.