Category Archives: Importation

PhRMA, pharmacists file suit to block Maine importation law

AstraZeneca commends our trade association, Pharmaceutical Research and Manufacturers of America (PhRMA), for joining in a lawsuit today challenging a new Maine law that allows for importation of medicines from certain foreign entities.

The law, which is to take effect Oct. 9, allows licensed retail pharmacies in Australia, Canada, Northern Ireland, New Zealand, or the United Kingdom to export prescription medicines by mail or carrier to any resident of Maine for their personal use.

PhRMA is joined in the federal lawsuit by the Maine Pharmacy Association, the Retail Association of Maine, the Maine Society of Health System Pharmacists and several individual pharmacists. The groups rightly say the pending Maine law “offers little in the way of protection for consumers. It does not require, for example, foreign pharmacies or importation facilitators to verify the validity or appropriateness of prescriptions being filled for individuals in the United States.”

Additionally, foreign pharmacies are not subject to the Food and Drug Administration’s jurisdiction, which means American customers are not protected by the agency’s gold standard safety regulations if they seek to import prescription medications from outside the country.

As John J. Castellani, President and CEO of PhRMA, said, “We seek to protect Maine’s patients by invalidating this law, which conflicts with the national prescription drug regulatory structure established by Congress and implemented by the FDA. Patient safety must come first and without Federal oversight of a tightly regulated, secure supply chain, there is a real risk of adulterated or counterfeit products infiltrating our medicine supply. If successful, we look forward to working with Maine legislators and leadership to develop a strategy that addresses their concerns, without putting their residents at unnecessary risk of harm.”

AstraZeneca agrees. We believe the importation of medicines from outside the US drug regulatory system places the public health at risk because the safety of the medicines cannot be monitored or authenticated by the FDA, US Customs, or other foreign regulatory bodies. This lack of oversight can result in mishandled, tainted, or counterfeit products entering the US drug supply.

DOJ settlement targets unlawful importation

Google agreed yesterday to forfeit $500 million for “allowing online Canadian pharmacies to place advertisements … targeting consumers in the United States, resulting in the unlawful importation of controlled and non-controlled prescription drugs into the United States.”

The U.S. Department of Justice gets to the heart of the underlying issue in its news release:

The importation of prescription drugs to consumers in the United States is almost always unlawful because the FDA cannot ensure the safety and effectiveness of foreign prescription drugs that are not FDA-approved because the drugs may not meet FDA’s labeling requirements; may not have been manufactured, stored and distributed under proper conditions; and may not have been dispensed in accordance with a valid prescription.

Also:

While Canada has its own regulatory rules for prescription drugs, Canadian pharmacies that ship prescription drugs to U.S. residents are not subject to Canadian regulatory authority, and many sell drugs obtained from countries other than Canada which lack adequate pharmacy regulations.

AstraZeneca agrees. We believe the importation of medicines from outside the US drug regulatory system places the public health at risk because the safety of the medicines cannot be monitored or authenticated by the FDA, US Customs, or other foreign regulatory bodies. This lack of oversight can result in mishandled, tainted, or counterfeit products entering the US drug supply.

See what PhRMA has to say on the settlement here.