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.