N.J. generic drug industry would benefit from federal bill

February 14. 2012 2:06PM

N.J. generic drug industry would benefit from federal bill

A bill to speed up low-cost generic drug delivery to patients will boost New Jersey's generic drug industry, create jobs and save consumers billions of dollars, according to U.S. Rep. Frank Pallone Jr. (D-Long Branch), who introduced the proposed legislation.

The bill, known as the Generic Drug and Biosimilar User Fee Act of 2012, will authorize generic drug manufacturers and the Food and Drug Administration to expedite review of generic drug applications, and provide funding to review and approve lower-priced versions of complex, living cell-based biologic drugs, known as biosimilars.

"There's a significant backlog of (generic drug) applications at the FDA because it takes 32 months to approve generics applications, while brand names' only take 10," Pallone said. "If this bill is passed, 90 percent of generic applications will be reviewed and approved at the same rate of brand names, speeding production and creating more jobs."

While guidelines for biosimilar application approval have not yet been established by the FDA, the agency has proposed collecting nearly $300 million in annual fees to hire more generic-drug reviewers beginning in October, also will speed the process of drug delivery, according to Pallone.

Biosimilars are priced significantly less than brand-name drugs, but they'll still cost generic drugmakers tens of millions of dollars to produce.

According to an IMS Health report from September 2011, consumers nationally saved $931 billion over the past decade through the use of generics. Currently, generics make up 78 percent of all prescriptions in the United States, but only 25 percent of prescription spending.