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Bills would close a loophole used by brand name drug companies to delay market introduction of affordable generic drugs

(Washington, D.C.)U.S. Senators Jeanne Shaheen (D-NH) and David Vitter (R-LA) today introduced legislation to provide patients with faster access to affordable prescription drugs. The bipartisan Access to Affordable Medicines Act would close a loophole some brand name drug companies exploit that needlessly and unfairly delays the entry of safe, lower-cost generic drugs to the consumer market.

"A key component of reforming the health care system is fixing what doesn't work," said Shaheen.  "Allowing brand name drug companies to purposefully delay consumer access to more affordable generic drugs is a perfect example of what is wrong with our nation's health care system, and this bill offers a commonsense and necessary solution to a costly problem."

"As we continue to debate health care reform, one of our top priorities should be lowering costs for prescription drugs," said Vitter. "This bipartisan bill will do just that by closing a loophole exploited by big drug companies and making lower-cost generic medications more widely available. I am glad to have worked with Sen. Shaheen on this bill to improve the affordability and availability of quality affordable prescription drugs for all Americans."

The Shaheen-Vitter legislation would close a loophole used by brand name drug companies to delay generic drugs from entering the market.   As the law currently stands, when brand name manufacturers make labeling changes, generic drug labeling must reflect the change prior to approval and introduction to the market. This law was created with consumer safety in mind, so that all current drug safety and warning information would be reflected on the label.  However, many brand name drug companies make last minute changes to labels not because of safety concerns, but instead to delay the introduction of cost-saving generic drugs by weeks or months to maintain market exclusivity.

For example, bicalutamide tablets, which are used to treat prostate cancer, are sold under the brand name "Casodex."  According to the Generic Pharmaceutical Association, consumer access to the generic version of this drug was delayed by more than 3 months due to a last minute pediatric labeling change, resulting in an estimated $75 million profit for AstraZeneca and costing consumers an estimated $15 million.

The Access to Affordable Medicines Act would stop these costly practices by providing a 60-day grace period for the generic drug company to submit the new labeling for approval and marketplace distribution. The bill includes safeguards so that in the event the new labeling truly presents a safety issue, the FDA would prohibit the medication from entering the market until the generic manufacturer updated the labeling.

The Access to Affordable Medicines Act is endorsed by the AARP, Generic Pharmaceutical Association and Consumer's Union.