Senate Passes Bill to Speed Up Approval of Key Medicines

A similar bill is on a fast track to approval in the House, perhaps as early as next week. President Obama, consumer groups and pharmaceutical companies strongly support the legislation.

The measures reflect the government’s effort to keep up with new therapies developed during a decade of rapid progress in biomedical research. After months of legislative paralysis and political sniping, the sight of Democrats and Republicans working together on a significant bill was remarkable.

The Senate vote was 96 to 1. The no vote was cast by Senator Bernard Sanders, independent of Vermont, who said the measure did “far too little” to make drugs more affordable.

The bill would increase the government’s reliance on user fees, requiring makers of drugs and medical devices to pay $6.4 billion over five years to help finance the evaluation of their products by the Food and Drug Administration.

The measure reauthorizes user fees for brand-name drugs and medical devices, and it introduces fees for the review of generic drugs and less expensive versions of certain biotechnology products, known as biosimilars.

The chief sponsor of the bill, Senator Tom Harkin, Democrat of Iowa, said the fees for generic drugs “are expected to slash review times to a third of current levels, from 30 months to 10 months, and will improve the speed with which generic products are made available to patients.”

Mr. Harkin, the chairman of the Senate health committee, wrote the bill over the last 18 months with Senator Michael B. Enzi of Wyoming, the senior Republican on the panel.

About 60 percent of the money for the review of applications for new drugs already comes from industry fees, which are used by

You can read the rest of this article at: http://www.nytimes.com/2012/05/25/us/politics/senate-passes-bipartisan-bill-on-new-medicines.html

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