FDA User Fee Bill Gives Agency New Powers to Inspect Overseas Prescription Drug Plants

Publication: The Associated Press

Author: Matthew Perrone

06/27/2012 - 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 Senate approved the must-pass piece of the legislation by a vote of 92-4, and President Barack Obama is expected to sign it into law within days.

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.


The bill passed by Congress would drop a requirement that FDA inspect all U.S. drug factories every two years and let it focus on foreign facilities, which it now typically inspects every nine years. The new bill requires that FDA inspectors target the most problematic manufacturing sites, regardless of whether they’re in the U.S. or overseas.

“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


Read the full Associated Press article, FDA User Fee Bill Gives Agency New Powers to Inspect Overseas Prescription Drug Plants, on the Washington Post's website.

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