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Posted 21 December 2015 | By Zachary Brennan
Members of the House Committee on Energy and Commerce are calling on the Government Accountability Office (GAO) to investigate whether the US Food and Drug Administration (FDA) is properly overseeing the pharmaceutical supply chain, particularly in China and India.
Reps. Fred Upton (R-MI), Frank Pallone (D-NJ), Tim Murphy (R-PA) and Diana DeGette (D-CO) acknowledge FDA’s work on meeting the rising demands of more foreign active pharmaceutical ingredient (API) and finished-dose manufacturers in India and China, though they remain “concerned that there is still inadequate oversight with regard to these foreign drug plants, not to mention an unequal playing field compared to US drug manufacturers that are subjected to more frequent and rigorous inspections.”
As a Focus review from November shows, India has seen an increasing number of Form 483s and warning letters from FDA in recent years, particularly with regard to data integrity issues. And FDA has also been tracking down issues in Asia, with the recent addition of three Asian companies to its import alert list, which now includes 21 more foreign manufacturing sites in 2015. In total, FDA has barred 38 plants in China from exporting some or all of their products to the US because of manufacturing violations, according to the representatives.
And perhaps compounding the issue of keeping up with Chinese and Indian growth in manufacturing: FDA has very limited resources in both of those countries to inspect facilities (some reports cite a total of two FDA inspectors in China and about a dozen in India).
Due to these persistent concerns, the representatives are calling on GAO to determine:
Energy and Commerce Letter to GAO
Tags: FDA, China, India, drug manufacturing, foreign drug manufacturing
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