Last week, yet another state, New Hampshire hopped on the Canadian drug importation bandwagon. Joining Vermont, Florida, Colorado, Maine and New Mexico, New Hampshire passed a law that would permit registered wholesale pharmacies to import lower-cost drugs from registered Canadian wholesale pharmacies. I have supported the initiative from the beginning, when the National Academy for State Health Policy (NASHP) came out with model legislation on drug importation from Canada. But now, frankly, I am annoyed. New wholesale drug imports from Canada can be helpful, but the issue seems to be used for political purposes. State legislators and governors, by passing Canadian drug importation laws, can say they are doing something, but nothing is actually happening.
One of the best opposing arguments surrounding these laws is that Canada is too small a country to take on large wholesale prescription drug exports to the U.S. With more and more states getting onboard with importation, the problem of Canada’s size becomes more salient. Expanding importation to the European Union is the key and yet this new state legislation, as well as federal law, does not address that.
More frustrating still, the problem with these state laws is that they do not go into effect without permission from the Secretary of Health and Human Services (the “Secretary”). The federal government is seemingly closer to granting that permission, as it has drafted rules that received public comment, including by yours truly. Adding insult to injury, the FDA’s proposed rule, if implemented without serious revisions, will make it easy for drug companies to implement supply restrictions. It would be technically legal yet functionally very difficult to import wholesale quantities of lower-cost prescription drugs from Canada.
Taking a step further back, the thing about these state laws is that they are not even necessary. Federal law holds that if the Secretary affirms there is no additional public health risk and it would achieve substantial savings, subject to a variety of limitations on what drugs could be imported, importation from Canada is legal. This has been the case for about 20 years now. First with the Medicine Equity and Drug Safety Act of 2000 (the MEDS Act), which became law as part of an Appropriations bill passed in 2000, and then with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This was, of course, before recent state drug importation laws were proposed. Federal law simply says it can be done but does not force the issue.
Honestly, it is irresponsible to insist that we cannot safely import drugs from Canada. However, since the HHS Secretary or the FDA is neither mandated nor motivated to deal with new regulatory pathways, things have just stalled. For years, in their opposition to the policy, the drug companies have said that “no Secretary has been able to certify the safety of Canadian drug importation… See? … It’s not safe.” But that statement is not true. The mechanism to import from Canada has simply not been created. So, initially, I liked the state laws and, even more so, the work of NASHP to develop a feasible regulatory framework to put a program in front of the Secretary.
I mean, way to go New Hampshire! But the first state law was passed over two years ago in Vermont and the waiting continues.