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Pharmaceuticals / Quality / Regulatory Affairs / Commercial Operations

FDA Warns About Suspect Canadian Online Pharmacies

Jan. 16, 2014

The FDA is continuing to alert consumers about the dangers of online pharmacies, releasing a fresh warning Wednesday that also notes the agency plans to position its first permanent criminal investigator overseas to assist its European counterparts in all matters of regulatory enforcement.

Most “Canadian” online pharmacies, the agency claims, peddle drugs that do not contain the proper active ingredient; they may even contain harmful or life-threatening ingredients. Many such websites describe their products as “brand name” and “FDA-approved” when, in truth, they’re neither, the agency says. The FDA maintains a site to help consumers differentiate legitimate online pharmacies from fraudulent ones at www.fda.gov/BeSafeRx.

In March 2013, the agency’s Office of Criminal Investigations created a special Cybercrimes Investigations Unit that works with domestic and international agencies to find and bring to justice operators and suppliers of websites that provide counterfeit medicines.

Three months later, the agency seized and closed down 1,776 such websites, most of which claimed to be Canadian.

The legalization of importing drugs into the U.S. is turning out to be a hot-button issue for the pharmaceutical industry in 2014, after passage of a new Maine law last year allowed for imports of prescription drugs from online retailers in Canada, the UK, Australia and New Zealand.

PhRMA, the Maine Pharmacy Association and other state pharmacy and retail groups sued in September to nullify the law, claiming that it violates the 1938 FD&C Act. Importing prescription drugs from abroad is still banned in most states, though the FDA usually does not pursue individuals importing drugs for up to 90 days of personal use. — Lena Freund

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