Made in the USA Foundation Files FDA Complaint Against Major Drug Retailers

LOS ANGELES, March 10, 2015 /PRNewswire/ -- The Made in the USA Foundation filed a complaint with the U.S. Food and Drug Administration against all large drugstore chains for failing to label the country of origin of prescription drugs.  The FDA complaint is part of the Made in the USA Foundation Project COLD: Country of Origin Labeling for Drugs project.

The complaint cites FDA, U.S. Customs and International Trade Commission rulings and regulations that require the drug labeling. About 40% of all over-the-counter and generic drugs used in the United States are produced in India. A similar amount of prescription drugs are imported from China.

In 2014, inspectors from the FDA investigated 160 drug plants in India. What they found was often quite alarming. Drugs were sometimes adulterated or contaminated. Facilities were often filthy or infested with insects. Because of unhealthy conditions, the FDA banned the importation of drugs from several Indian factories.

"If I have to follow U.S. standards in inspecting facilities supplying to the Indian market," G. N. Singh, India's top drug regulator, said in a recent interview with an Indian newspaper, "we will have to shut almost all of those."

The World Health Organization estimated that one in five drugs made in India are fakes. One widely used antibiotic was found to contain no active ingredients after being randomly tested in a government lab.

China, unlike India, has blocked U.S. efforts to send FDA inspectors. "China is the source of some of the largest counterfeit manufacturing operations that we find globally," said John P. Clark, Pfizer's chief security officer concerning the safety of drugs from China.

Foreign drug and supplement plants producing for the U.S. market are supposed to meet FDA standards. But the GAO report said the FDA over the past few years had checked only 12 percent of the hundreds of Chinese plants producing pharmaceutical ingredients or finished products for the U.S. market.

One consequence of the lack of regulation has been a rising number of counterfeit drugs, said Peter Pitts, current President of the Center for Medicine in the Public Interest in New York City and a former associate commissioner of the FDA. One case involved counterfeit influenza medicine from China that was supposed to be Tamiflu, but contained none of its active ingredients. "It's a nascent public health crisis and we shouldn't wait until we have bodies in the street," said Pitts.

In 2008, a contaminated ingredient from China showed up in heparin, a blood-thinning medicine that was linked to 149 deaths.

With all the risks of drugs from China and India, the only way that consumers can protect themselves is to refuse to purchase these risky products.  And the only way that we can do this is to force companies to provide the country of origin of their products.  That is why we asked the Food and Drug Administration to enforce the law that requires pharmacies to label all prescriptions with the country of origin of the pills that we take to treat serious health problems.

SOURCE Made in the USA Foundation