Stabenow Provision Lowering Prescription Drug Prices Goes to the President for His Signature
Bipartisan effort will eliminate frivolous petitions that delay access to generic drugs, costing consumers millions
U.S. Senator Debbie Stabenow (D-MI) today announced final passage of her bipartisan provision 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 provision was part of the larger Food and Drug Administration Authorization Bill and will now go to the President for his signature.
"This legislation is a victory 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. This is a critical step in the fight to make prescription drugs more affordable for all Americans."
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.
Stabenow's provision is part of the larger Food and Drug Administration Authorization Bill which will reauthorize the FDA's prescription drug and medical device user fee programs, and also includes provisions to improve drug safety, track clinical trials, and publicize clinical trial results.