Well, as I was writing this post about the politics of importation, the FDA published its final rule on drug importation. Find it here: Section 804 Final Rule. It’s 179 pages so I haven’t had time to read it all yet.
As a quick reminder, pursuant to Section 804 of the Food, Drug and Cosmetic Act, the FDA issued a proposed new rule to allow wholesale imports of lower-cost drugs from Canada, subject to many conditions and excluding expensive biologics. Phillip Galewitz of Kaiser Health News asks if this is an “election gift for Florida” reporting that Florida will be the first state granted approval to import by the FDA. This is not surprising. Florida has an exceptionally large number of retired, older Americans who are unhappy about the cost of prescription drugs and 29 electoral college votes that Trump cannot afford to lose.
The Secretary of Health and Human Services has now certified no additional safety risks and the realization of substantial savings from importing lower cost drugs from Canada, under certain conditions. But the rule states that personal importation provisions are not in effect. Really?! Maybe they want to write a new importation law without Congress. These days, who knows what might happen? Arguments were made even before the certifications of safety and savings by the Secretary, the personal drug importation provisions protected personal drug imports. As I see it, now that Section 804 in its entirely is in effect, personal importation is more expressly permitted than before.
The FDA’s rule on Section 804 describes the conditions under which eligible entities in the U.S., such as states and their designated wholesalers, can import lower cost drugs from Canada. There is a lot of debate about how much this can actually help with drug prices. It’s no secret that I am a staunch supporter of drug importation to help end the stranglehold Big Pharma has on the American people – even though it is just one policy tool in the shed – but even I believe that this limited opening of the door to wholesale imports might be of little help. Here are three primary reasons:
One, Canada is too small of a country for largescale importation and the Canadian government is not psyched at the prospect of the U.S. siphoning off their drug supplies.
Two, if you read the rule, it makes it easy for drug companies to restrict supplies to pharmacies in Canada so that they do not get into this market.
Three, Section 804 excludes biologic drugs from the list of possible import. Biologics, medical products derived from living organisms, are much more expensive than regular drugs.
Even with those limitations, I support this final rule to allow states to proceed with trying to use importation from Canada to ease cost burdens. It can help. We will just have to see how much. What may be more important is that the rule and policy momentum in favor of importation help debunk the myth that drug importation is not safe. It is safe. Expanding beyond Canada, through further legislative and regulatory reforms to Europe and Japan, is the way forward. That would work to bring down drug prices dramatically.
I submitted public comments regarding the drug importation rule back in March urging the FDA to open the door further to personal (not just wholesale) importation. For years, without this express permission under law, millions of Americans have already been benefiting from buying drugs internationally from licensed pharmacies in other countries. My public comments gave specific steps the FDA could take to help more Americans benefit. I started this blog post reporting what the rule states on personal importation and my belief that the rule leaps far beyond what the law allows for! Reminder: the FDA, according to Section 804, which is in effect, should allow personal importation. I’ll take this further next week.
I have to add for posterity: I hope to God that this drug importation momentum carries over into a Biden administration next year. Biden will hopefully bring other policy tools to the table to lower drug prices, not to mention saving our nation’s democracy…
