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FDA Dislikes Canadian Drugs; Is OK With Chinese Drugs

FDA Commissioner Margaret Hamburg said that allowing reimportation of drugs from Canada raised significant safety questions, in a letter to to Republican Sen. Sam Brownback of Kansas, according to the Wall Street Journal. The story notes that the drug industry lobby group PhRMA also opposes reimportation and has been fighting problems with unsafe counterfeit medicines.

The remarks are interesting given how few resources the FDA has devoted to ensuring the safety of legally imported drugs from China and other Eastern countries. BNET noted a few days ago that the FDA has only two staff members inspecting drug factories in China, and that European authorities make only 19 non U.S./European inspections per year. Yet Pfizer (PFE), AstraZeneca (AZN), Eli Lilly (LLY), Novartis (NVS) and many other drug companies are moving R&D and production facilities to China.

Drugs made in China are imported legally to the U.S. as if they were "American" drugs. The drug industry merely opposes allowing Americans to buy the same Chinese-made drugs from Canada, where price controls have rendered them cheaper.

Taken with the lack of inspectors in China, Hamburg's letter seems to imply that if drugs enter the U.S. from any foreign country the FDA simply can't be sure they are safe.

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