The Trump administration continues to spar with the pharmaceutical industry. The latest jab is the reemergence of the discussion on drug importation. U.S. Department of Health & Human Services (HHS) Secretary Alex Azar reversed the administration’s course on whether drugs could be purchased outside of the United States and reimported.
The reality is that drugs are less expensive in other countries due to several factors. Perhaps the biggest reason is the negotiation tactic of these governments’ controlled healthcare, which puts a lid on cost by tightly managing the formulary of drugs available in that country – and this is influenced to a great extent by those countries’ ability to pay. Other reasons are lower regulatory and litigation costs and that Big Pharma views revenues from these countries as gravy to the revenue generated in the U.S. and other more lucrative markets.
Azar has directed the Food and Drug Administration (FDA) to create a working group to study whether reimportation can be done. He is not alone. Several states including Colorado, Florida, and Vermont have already started this process. The biggest concern is the lack of oversight by the FDA into the manufacturing and distribution process. Counterfeiting of drugs has been identified as an issue even in the U.S. With global procurement this issue becomes even more significant.
The Azar plan would have HHS and FDA oversee demonstration projects that would allow states and certain drug distributors to import drugs from Canada. These drugs would have to use a separate National Drug Code and be tracked separately. But it will be some time before the rules are written to implement these plans.
The Trump administration has turned back its focus to reimportation as its other efforts to control drug costs (price disclosures and outlawing rebates) met resistance and, at least for now, have hit a wall.
One thing about our President: he is persistent and will keep trying but it is unlikely that Big Pharma is going to lose this battle without a big fight. Grab your low-fat popcorn – it’s going to be a while before you can get your low-cost Canadian “fat blaster” medications and perhaps a bigger chance you will never get them.