New legislation would legalize personal importation of certain foreign drugs

By Dara Katcher Levy –

Recently, a bill was introduced into the House of Representatives that would legalize personal importations and re-importations of certain foreign drugs.  The Personal Drug Importation Fairness Act of 2013 (H.R. 3715) would allow Americans to buy prescription drugs from certain countries deemed to have comparable safety standards to the United States, including Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and countries in the European Union.  The drug imported must have the same active ingredients, route of administration, and strength as an FDA-approved prescription drug, and the purchase must be accompanied by a valid prescription for a supply not exceeding 90 days to be dispensed by a licensed pharmacist. 

The stated intent of the bill is to permit individuals access to drugs at lower costs. Although FDA prohibits the import of unapproved drugs, FDA’s current policy is to exercise enforcement discretion to allow certain personal imports that meet set criteria.  FDA has repeatedly reminded consumers and industry that such imports are illegal and FDA’s exercise of enforcement discretion has been inconistent.  Read more about FDA’s policy on these imports here, here, and here. 

The bill comes on the heels of Maine’s recent law that effectively legalized the import of certain prescription drugs from certain pharmacies.  In mid-October 2013, Maine became the first state to permit its residents to legally import foreign drugs from accredited pharmcies in Canada, the U.K. and certain other countries (see our previous posts here and here).  This bill may be an attempt by the federal government to curtail similar statutes from other states and to establish standards for the types of permissible imports.