Brown to FDA: pay close attention to imported drugs


Brown to FDA: pay close attention to imported drugs

Columbus Dispatch – The Federal Drug Administration is reviewing how it inspects and clears products imported from other countries — and Sen. Sherrod Brown has questions.

The Ohio Democrat wrote a letter to FDA Commissioner Margaret Hamburg today applauding the FDA for a new strategy and emphasis on reviewing imported products, but saying he still has questions and concerns.

Among them: Whether inspectors are denied access to foreign pharmaceutical companies, as well as whether the FDA has the right to keep products from being imported into the United States if FDA inspectors are barred from the manufacturing facilities.

Brown also has worries about China, India and Mexico, which represent the largest exporters to U.S. markets. He said he’s concerned about reports that the Chinese government has not always cooperated with FDA investigations.

His letter is a response to a new FDA report, “Pathway to Global Product Safety and Quality,” which calls for the agency to take a more global approach to securing products used by U.S. consumers. That report found that more than 80 percent of active ingredients for drugs sold in the United States are made abroad.The report advocates for more overseas inspections, but notes that current staffing and funding levels may make meeting such a goal difficult, if not next to impossible.

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