New Brunswick Patch

Pallone Visits Drug Plant in Support of Pending Generics Legislation

Congressman Frank Pallone is a sponsor of the "Generic Drug and Biosimilar User Fee Act of 2012" which would speed up the FDA approval of generic drugs

New Brunswick Patch —Tuesday, February 14, 2012

By Jennifer Bradshaw

Millions of consumers may have increased access to generic prescription drugs before the end of the year if legislation proposed by Congressman Frank Pallone (D-NJ) passes in the next few months.

The "Generic Drug and Biosimilar User Fee Act of 2012", if approved, would authorize an agreement between the Food and Drug and Administration and generic drug manufacturers, according to Pallone's office.

The end result would be speedier approval of generic drugs, getting them created and available to consumers faster.

According to Pallone, drug applications must go through the FDA for approval, but there is a backlog of generic applications specifically of up to 32 months, a length of time he called "unacceptable."

Pallone gave a speech Monday at Ranbaxy Pharmaceuticals in New Brunswick, an international generic drug company with an on-site plant and research facility that employs close to 600 people.

He was joined by Mayor James Cahill, Jeff Brown of the New Brunswick-based New Jersey Citizen Action and Patrick Gill of Horizon Blue Cross Blue Shield, as well as about two dozen Ranbaxy Pharmacueticals employees and managers.

"Generic drugs save lives at lower cost, and bringing generic and biosimilar drugs to market faster must be a priority," said Pallone, in a statement issued after the event. "This bipartisan legislation will go a long way to giving the FDA the resources it needs to review these drug applications in a timely and effective manner."

Ranbaxy Pharmaceutical's largest production plant is located in New Brunswick, and produces the generic of Lipitor, known as Atorvastatin.

Production of the generic cholesterol medication began in November. According to company officials, Ranbaxy produces approximately two million bottles of Atorvastatin per month.

Venkat Krishnan, Senior Vice President and Regional Director for Ranbaxy Pharmaceuticals praised Pallone's support of the generics drug industry, and stated that the medications bring treatment to millions of people, but at a much lower cost.

The bill also contains support for biosimilar drugs, and would allot money toward further research and approval of this branch of pharmaceuticals, according to Pallone's office.

It recently received bipartisan approval by the House Energy and Commerce Committee.

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