This week, the Colorado Department of Health Care Policy and Financing issued a request for proposals, called an Invitation to Negotiate, to operate a state wholesale drug importation program as permitted under federal law and the administrative final rule issued by HHS last year, referred to as the Section 804 rule. Colorado’s proposal request is chock full of details, with many regulatory and legal issues addressed, quite ably predicting pushback from drug companies who virulently oppose importation. Notably, it addresses the Canadian government’s valid concerns about new drug importation channels from the United States aggravating Canadian drug shortages.
Last year, just before the Section 804 rule went into effect, the Canadian government issued an interim order mandating that Canadian wholesale pharmacies not export drugs that could create or exacerbate domestic drug shortages. Certain drugs will require proper supply reporting before approved for export. The pharmaceutical industry’s flawed and, in some cases, false arguments against importation invoking drug safety issues are not working to stop the momentum on Section 804 state programs. In the industry’s public relations and lobbying efforts against the program, they often highlight Canada’s understandable and protective response. That won’t work either.
Colorado’s RFP is clear in its obligation to not cause drug shortages in Canada. A full quote from the proposal is in order here:
Drug importation, by which I mean the process of buying much less expensive and equally safe prescription drugs from other countries, may see more sunlight under the Biden administration. For many drugs, the prices are frequently 90% less in other countries. Biden included drug importation among several policies he plans to pursue to lower drug prices. There’s momentum on drug importation from the Trump administration in the form of:
- An executive order calling for drug importation
- A final rule by the U.S. Food and Drug Administration to allow wholesale importation from Canada
- A request for proposal for personal drug importation programs
- a request for proposals relating to the importation of Insulin
For someone who believes that Donald Trump’s actions, especially recent ones, have threatened the core of our democracy, it’s difficult to admit that the Twitter ban against him strikes a nerve with me. Getting right to the point: in the summer of 2018, Instagram shut down PharmacyChecker’s account. PharmacyChecker, which I co-founded in 2002, is a small, independently-funded online pharmacy verification and drug price comparison website. One of its claims to fame is providing information for consumers that can help them safely obtain lower-cost prescription drugs from other countries. PharmacyChecker helps people avoid rogue pharmacy websites and save money. So why did Instagram shut it down?
Germane to the matter is the fact that under most circumstances federal law prohibits the importation of prescription drugs for personal use. However, federal law makes many allowances to permit it anyway, despite the prohibitions. Tens of millions of Americans have imported medicines for personal use and none have been prosecuted for doing so. PharmacyChecker does not import, sell, distribute, process orders for medication in any way. It provides information. That information may be controversial but it’s not illegal. Nonetheless, it poses a threat to the pharmaceutical industry, which needs Americans to pay the highest prices on drugs to maintain their incredible profit margins. You see where this goes.