Most recently, with their introduction and co-sponsorship of the Safe and Affordable Drugs from Canada Act, the Senators have shown that there is Congressional recognition that personal importation can be conducted safely from Tier One countries, benefiting Americans who would otherwise be denied access to their medicines simply because they cannot afford the cost of medicines in the U.S.
This legislation enables Americans wishing to engage in personal importation of medicines dispensed by Canadian pharmacies to do so under rules to be promulgated by the Secretary of Healthand Human Services.
This is a significant mandate to the Secretary that differs from previous bills that only urged the Secretary to conduct studies on how personal importation could be made possible.
In addition, the bill, in and of itself, refutes Section 708 of the misnamed Food and Drug Administration Safety and Innovation Act (FDASIA) which would permit the seizure and destruction of personally imported safe valid prescription medicines valued at $2500 or less for reasons that have nothing to do with safety or efficacy. The FDA is now promulgating rules for Section 708 to be released in September 2015.
Since the HHS Secretary would be obligated under the Klobuchar-McCain legislation to promulgate rules to enhance personal importation , the FDA, which is an HHS agency, should ensure that the rules it promulgates for Section 708 do not destroy valid, safe personally imported medicines for reasons that have nothing to do with safety or efficacy.
One of the primary reasons for seizures under Section 708 is ‘misbranding’. This is the description of medicine labels that, even though they meet all the labeling requirements of the countries of origin from which they were dispensed, would be subject to seizure and destruction irrespective of their efficacy or safety because there is a difference between the label of the country from which the medicine is shipped and that of the U.S.
Medicines from Canada could be disallowed simply because they are printed in both English and French. This does not affect the safety or validity of the medicine, and even though they are for the very same medicines that would be allowed by The Safe and Affordable Drugs from Canada Act, they could be disallowed by misapplication of Section 708.
Support and passage of The Safe and Affordable Drugs from Canada Act is a forceful signal to HHS, of which the FDA is an agency, that Congress recognizes that there are sources for safe personal importation of prescription medicines, and that this is to be the policy that Congress endorses, not unjustified seizures under Section 708.
Personal importation was started in the late 1990s by Elderly Americans crossing the border into Canada to fill their prescriptions. Today, large numbers of groups and municipalities across the US have entered into plans that offer choices for employees and members to purchase their medicines internationally from pharmacies in Tier One countries such as Canada, Australia, New Zealand, and The United Kingdom.
Also, the Maine Legislature has enacted a law that allows its citizens topurchase brand name medicines from pharmacies in Canada, Australia, New Zealandand the United Kingdom.
Now, with their co-sponsorship of this bill, Senator Klobuchar and Senators McCain continue to support the right and the ability of Americans to make responsible health care decisions. This historic legislation will be a model for further advancing the safety, health and well-being of all Americans. We applaud the efforts of the Senators.
