U.S. lawmakers push FDA to increase China, India oversight

Print 23 December 2015
Matthew Driskill / FiercePharmaAsia

Two American congressmen have written to the U.S. Government Accountability Office asking the agency to investigate the U.S. Food and Drug Administration's inspection work for pharma manufacturing plants in India and China.

House Energy and Commerce Chairman Fred Upton (R-MI) and Rep. Frank Pallone (D-NJ) said they were concerned that "there is still inadequate oversight with regard to these foreign drug plants," according to a report byBloomberg.

The report said the FDA currently has two inspectors in China for 700 plants, but the FDA said in response to the letter that they had hired three additional people for China inspections.

China and India account for about 80% of the main ingredients in the world's drug supply, according to the report, and both countries have been hit recently with FDA import bans and warnings because of quality control problems at manufacturing facilities. In several cases, Chinese and Indian drugmakers have falsified test results or otherwise tried to evade detection of problems by U.S. and European inspectors.

Source

Return