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Senate Approves Greater FDA Authority Over Drugmakers

05/29/12

  01:01:23 pm, by MedBen5   , 208 words,  
Categories: News, Prescription

Senate Approves Greater FDA Authority Over Drugmakers

In a rare display of near-unanimous bipartisanship, the Senate last week voted to approve a bill that will give the federal government greater oversight of drug companies.

According to The New York Times, the bill, which passed by a vote of 96-1, would impose new requirements to notify the Food and Drug Administration of potential drug shortages. Agency officials could then take steps to “help mitigate or prevent” the shortages, such as by importing additional medicine from foreign countries.

Additionally, the bill would reauthorize user fees for brand-name drugs and medical devices, as well as introduce fees for the review of generic drugs, in order to help finance FDA evaluation of their products.

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,” said Senator Tom Harkin (D-Ia.), the chief sponsor of the bill.

The lone holdout in approving the bill was Senator Bernard Sanders (I-Vt.), who said the measure did “far too little” to make drugs more affordable.

The House of Representatives is expected to okay a similar bill this week. President Obama, consumer groups and pharmaceutical companies strongly support the legislation.

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