Are Canadian Prescriptions On Their Way To The U.S.?

Senators John McCain (R-Ariz) and Amy Klobuchar (D-Minn) have reintroduced a bill titled, “The Safe and Affordable Drugs from Canada Act.” The bill would amend the federal Food, Drug, and Cosmetic Act (FDC Act) to allow for the personal importation of safe and affordable prescription drugs from approved pharmacies and/or pharmacists in Canada. As of January 8, 2015, S.B. 122 has been read twice and referred to the Health, Education, Labor, and Pensions (HELP) Committee.

Proposed Legislation

The bill was previously introduced as The Safe and Affordable Drugs from Canada Act of 2014 (S. 2549) by the senators to permit the personal importation of a 90-day supply of a drug for personal use if obtained from a licensed Canadian pharmacy and pharmacist. Under this bill, a prescription drug would have to be filled using a valid prescription issued by a physician licensed to practice in the United States and contain the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FDC Act. This bill also established criteria for approval of a Canadian pharmacy and required HHS to publish a list of approved Canadian pharmacies, including their website address, from which individuals may purchase prescription drugs as part of this Act.

Past Issues

The FDA cannot ensure the safety and effectiveness of products that are not FDA-approved and come from unknown sources and foreign locations or those that may not have been manufactured under proper conditions. Patients are at risk if they cannot be sure of the drug products’ identity, purity, and source. In 2005, the FDA conducted an investigative operation of pharmaceutical orders made over the internet. The FDA intercepted imported drugs from four selected countries and found that nearly 50 percent of these drugs were shipped to fill orders that consumers believed they were placing with “Canadian” pharmacies. Of the drugs being promoted as “Canadian,” based on accompanying documentation, 85 percent of them came from 27 other countries. A number of these drugs also were found to be counterfeit. Subsequent operations included seizures of more than 11.8 million tablets, capsules, and vials of counterfeit medicines from 49 countries in 2013. Thus far, the FDA recommends only obtaining medicines from legal sources in the United States.The bill, if enacted, would effectively implement the FDA’s current personal importation policy (PIP) for Canada.