Media Coverage

''FDA user fee bill gives agency new powers to inspect overseas prescription drug plants''


"A Food and Drug Administration bill designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home, is headed to the president’s desk after an overwhelming approval in the U.S. Senate.

...

The core of the bill is critical to the FDA: It bolsters the agency’s budget with billions of dollars in drug industry fees for scientists who review new medicines. For the first time, generic drugmakers will pay review fees to speed the approval of their products. Branded drugmakers have paid those fees for 20 years.

Lawmakers seized on the legislation to address recent concerns about the safety and quality of prescription medicines, especially those that are imported. The bill also gives the FDA new tools to fight counterfeiting and drug shortages, which have made headlines in the past year.

...

"This legislation will, for the first time, enable the FDA to regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications,” said Allan Coukell, director of the Pew Charitable Trusts’ medical programs.

The risks of unchecked foreign drug manufacturing hit home in 2008, when hundreds of U.S. patients suffered allergic reactions — some fatal — to a blood thinner imported from China. An FDA investigation concluded the drug had been contaminated, to reduce costs, with an ingredient that mimics the blood thinner heparin. 

Full article

Date added:
Jun 26, 2012

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