The Made in USA Foundation said on March 10, 2015, that it had filed a complaint with the U.S. Food and Drug Administration against large drugstore chains. The complaint accused the chains of failing to tell customers the country of origin of prescription drugs.
What the complaint says
The Los Angeles-based group said the complaint was part of its “Project COLD: Country of Origin Labeling for Drugs.” It argued that rulings and regulations from the FDA, U.S. Customs and Border Protection and the U.S. International Trade Commission require drugs to be labeled with their country of origin.
The foundation asked the FDA to enforce what it described as a legal duty for pharmacies to label prescriptions with the country where the pills were made.
Why the group says it matters
The foundation said about 40% of generic and over-the-counter drugs used in the USA are made in India, and a similar share of prescription drugs come from China. It pointed to problems found during FDA inspections of Indian drug plants in 2014, and to China’s limits on FDA inspectors.
“It’s a nascent public health crisis and we shouldn’t wait until we have bodies in the street,” said Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, in comments the foundation released.
The foundation said consumers can only avoid drugs they consider risky if companies disclose where the drugs are made.
The labeling question
FDA rules require drug labels to name the manufacturer, packer or distributor and its place of business. Those rules do not separately require a country-of-origin statement on prescription labels. The foundation’s complaint asked the agency to treat origin disclosure as required.
Source & credit
Source: Manufacturing.net: “Complaint: Drugstores Fail To Disclose Countries Of Origin On Prescriptions”, March 10, 2015.
Additional source: Made in the USA Foundation via PR Newswire: “Made in the USA Foundation Files FDA Complaint Against Major Drug Retailers”, March 10, 2015.