Statements on Introduced Bills and Joint Resolutions

Floor Speech

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Mr. BINGAMAN. Mr. President, I rise today with Senators Vitter, Merkley, and Brown of Ohio to introduce the Fair and Immediate Release of Generic Drugs Act of 2011. The FAIR GENERxICS Act is an important step in addressing the root cause of the growing cost of healthcare--the delay of generic drugs entering the market. This legislation has broad support from consumer advocates, the generics industry, and experts including: AARP, Apotex generics manufacturer, Families USA, U.S. PIRG, Consumers Union, Consumer Federation of America, Center for Medicare Advocacy, the National Legislative Association on Prescription Drug Prices, Alliance for Retired Americans, and Community Catalyst.

According to the Kaiser Family Foundation, prices for brand-name prescription drugs have continued to outpace inflation. Overall spending on prescription drugs also has increased sharply. In 2008 spending in the U.S. for prescription drugs was $234.1 billion, nearly 6 times the $40.3 billion spent in 1990. Generic drugs can be an important source of affordable prescription drugs for many Americans. On average, generic drugs are four times less expensive than name brand drugs.

Pay-for-delay patent settlements brand and generic pharmaceutical manufacturers, however, are delaying timely public access to generic drugs, which costs consumers and taxpayers billions of dollars annually. In 2010 the Federal Trade Commission reported 31 such settlements, a 60 percent increase since 2009, and in 2011 FTC reported 28 such settlements. Many experts and consumer advocates have called for legislation to address this problem and ensure access to affordable medicines for all Americans.

The FAIR GENERxICS Act of 2011 addresses the root cause of anti-competitive pay-for-delay settlements between brand and generic pharmaceutical manufacturers--the unintended, structural flaw in the Hatch-Waxman Act that allows ``parked'' exclusivities to block generic competition. By doing so, the legislation ensures consumers will benefit from full and fair generic competition at the earliest, most appropriate time.

The legislation would prevent ``parked exclusivities'' from delaying full, fair, and early generic competition by modifying three key elements of existing law. First, the legislation would grant the right to share exclusivity to any generic filer who wins a patent challenge in the district court or is not sued for patent infringement by the brand company. The legislation also maximizes the incentive for all generic challengers to fight to bring products to market at the earliest possible time by holding generic settlers to the deferred entry date agreed to in their settlements. Finally, in order to create more clarity regarding litigation risk for pioneer drug companies and generic companies, the legislation requires pioneer companies to make a litigation decision within the 45 day window provided for in the Hatch-Waxman Act.

As a result of these changes, companies who prevail in their patent challenges and immediately come to market may be the sole beneficiary of the 180 day exclusivity period. In addition, companies will understand litigation risk before launching generic products.

Taken in concert these changes will ensure that generic markets are opened as they were originally envisioned under the Hatch-Waxman exclusivity periods; and will generate significant savings for the U.S. consumers, the Federal Government, and the American health care system.

Mr. President, I ask unanimous consent that the text of the bill be printed in the RECORD.

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