U.S. Congress calls for a review of FDA regulation of pharmaceutical plants in Asia

Source: on December 30, 2015, due to concerns about the quality of the pharmaceutical supply chain, some members of Congress hope that the general audit office (GAO) will review and evaluate the progress of the US Food and Drug Administration (FDA) in supervising foreign production plants In a letter on Friday, members of the house energy and Commerce Committee asked the Gao to assess the FDA's progress in conducting a new "risk-based" approach to inspections of foreign facilities since 2010 They point out that the United States imports more than $52 billion a year in drugs, but "many of these products come from countries with inadequate regulatory systems." Parliamentarians then noted in particular that China and India have more than 20 years of "history" of counterfeiting, shoddy, substandard production and data fraud As a result, lawmakers believe that China and India are likely to be in an "inadequate regulatory" and "unfair competitive environment" compared to U.S pharmaceutical companies that are subject to "more frequent and rigorous scrutiny" The letter was co signed by Fred Upton, chairman of the house energy and Commerce Committee, Frank Pallone, vice chairman of the committee, Tim Murphy, chairman of the oversight and investigation Subcommittee, and Dinan DeGette, vice chairman of the oversight and investigation Subcommittee Due to the massive quality control scandals in the past few years, their requests are aimed at keeping an eye on the quality of finished drugs and active ingredients For example, 246 deaths in the United States in 2008 were linked to the discovery of counterfeit ingredients from China in the blood thinner heparin China is now the world's largest supplier of APIs In India, many pharmaceutical companies have been cited for making mistakes The most notorious example involves the Ranbaxy lab Now some of sun pharmaceutical's companies have become the typical representatives of quality control out of control Two years ago, sun pharmaceutical paid a $500 million fine as part of the settlement, which also included pleading guilty to two charges of violating drug safety laws, such as data manipulation To crack down on such practices, the FDA has taken steps to hire more inspectors in both countries, although plans in China are slow The FDA opened its China office after the heparin crisis, but encountered difficulties due to delays in obtaining required visas At present, China has two drug inspectors, and has recruited three additional inspectors to jointly supervise about 700 drug projects A FDA spokesman said more inspectors are expected to be deployed next year At the same time, disturbing violations continue FDA has banned 38 factories in China from exporting all or part of their products to the United States Lawmakers cited FDA inspectors inspecting Chinese companies that supply key APIs to large US pharmaceutical companies When the inspector walked into the quality control laboratory, a worker unplugged the flash memory from the computer and fled when asked to view the unplugged flash memory Problems are also emerging in India In a recent FDA warning letter to unimark remedies, FDA inspectors found evidence of "pests" in March 2014 Specifically, bird nests were found near the ceiling of the production building and bird droppings were found near the warehouse A lizard was found in another warehouse What's more disturbing is that several examples involving data integrity are found in computer systems FDA has begun to work with the Indian government to strengthen domestic regulation A FDA spokesman was unable to provide the number of inspectors working in India Indian pharmaceutical companies are angry at the FDA's concerns about persistent shortcomings, which have prompted the FDA to issue a steady stream of import warnings banning products from being shipped to the United States A FDA spokesman said the FDA would respond directly to the Gao, but there would be no comment A Gao spokesperson said that in response to the request "any decision will be made through the Gao's standard review process." It usually takes a few weeks "