Stabenow leads bipartisan effort to eliminate frivolous petitions that delay access to generic drugs
U.S. Senator Debbie Stabenow (D-MI) today announced passage of her bipartisan amendment that would put an end to frivolous petitions used by brand drug companies to delay the entrance of generic drugs into the marketplace, robbing consumers and businesses of affordable choices. The delayed access to lower priced generics costs employers, health insurance providers, government health programs and consumers hundreds of millions of dollars. The bipartisan amendment is also sponsored by Senators Trent Lott (R-MS), John Thune (R-SD), Sherrod Brown (D-OH), Herb Kohl (D-WI), Orrin Hatch (R-UT), and Tom Coburn (R-OK).
"This legislation is a victory for consumers and employers," said Stabenow. "When so many Americans are struggling to pay for the prescription drugs they need, we must put the needs of patients first and ensure access to quality, affordable healthcare."
Between the passage of the Medicare Modernization Act in late 2003 and April 30, 2006, the FDA ruled on twenty-five petitions filed by brand drug companies requesting delay - or outright denial - of approval of a competing generic drug. Twenty-three of these petitions were found to be frivolous, but still served to restrict competition from lower cost drugs, for days, weeks, months and in some cases years. A delay of even a few days meant an increased cost of $4 million to consumers and businesses in the case of one drug. Drugs that have been delayed for months have meant an increased cost of $50 million and more.
"Increased competition means lower prescription drugs prices for consumers and employers," said Stabenow. "These real health care savings are a critical component in staying competitive in a global economy and protecting American jobs."
Also passed by the Senate were two other Stabenow provisions that will lower the costs of prescription drugs. Originally introduced in the Lower PRICED Drugs Act by Stabenow and Lott earlier this year, one provision will keep drug companies from using rules meant to improve the information we have about the use of prescription drugs in children as a shield against the entry of generics into the market. The other will expand the list of antibiotics that are eligible for generic versions by eliminating a loophole that precludes competition among original uses of an arbitrary subset of antibiotics. The amendment is supported by a broad range of consumer, business, labor, pharmacy and other groups, including GM, Ford, DaimlerChrysler, the United Auto Workers, AFL-CIO, National Association of Chain Drug Stores and the AARP. The Senate passed the provisions as part of S.1082, the FDA Authorization Bill. The Senate will vote on the full bill later today.