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Generic Drug Manufacturers : Greater generic drug access and availability

A bipartisan coalition of House members, led by Representative Jo Ann Emerson (R-MO) and Representative Sherrod Brown (D-OH), today introduced the Greater Access to Affordable Pharmaceuticals Act. The legislation will increase competition and reduce prices in the prescription drug market by ensuring a more level playing field for generic drug access and availability.

"Spiraling prescription drug costs are jeopardizing employer-sponsored health insurance, undercutting the financial security of seniors, and absorbing an enormous share of the limited federal and state tax revenues devoted to health care. Now is the time for the House to step up to plate and deliver cost savings to American consumers," said Rep. Brown, who is the ranking member on the Energy and Commerce Health Subcommittee.

"Access to affordable prescription drugs is one of the most important issues facing our nation today," said Representative Emerson. "By eliminating some of the anti-competitive tactics used by drug manufacturers to keep lower-cost pharmaceuticals off the market, this legislation will provide relief to consumers from the escalating costs of prescription drugs. I will continue to press forward on a bipartisan basis to ensure this issue is addressed during the ongoing debate on Medicare reform."

The legislation, which is a companion to a bill the Senate is set to consider this week, is designed to make it tougher for makers of brand-name drugs to block cheaper generic drug manufacturers from the market. Senators Judd Gregg (R-NH), Charles Schumer (D-NY), and John McCain (R-AZ) are the chief sponsors on the Senate side.

The Emerson-Brown legislation would prevent brand and generic drug manufacturers from exploiting legal loopholes to block competitors from the market. Under current law, drug makers can keep lower-priced products off the market indefinitely by attaching "last minute" patents to their drugs and by cutting anti-competitive deals with would-be competitors. The Brown-Emerson bill includes three key provisions to end these abuses:

  • Permits only one 30-month delay in FDA approval of a generic drug when a brand name sues to block that generic drug from the market.
  • Strips market exclusivity from generic drug companies found to have made anti-competitive deals with brand name drug makers.
  • Permits the generic drug industry to challenge "last minute" patents used by brand-name drug makers to block competitors from the market.
The pharmaceutical industry’s tactics have hurt consumers and businesses dealing with the rising cost of prescription drugs. In 1990, the average cost per prescription for brand-name medications was $27.16, while the average cost for generic drugs was $10.29. By 2000, the average cost per prescription reached $65.29, while the generic increased to only $19.33.

In addition to Brown and Emerson, lead sponsors include Zach Wamp (R-TN), Mary Bono (R-CA), and Rahm Emanuel (D-IL). The bill’s supporters are pushing for the House to include it in any Medicare prescription drug plan.



June 17, 2003 © Yenra