Originally published on PharmacyChecker.com.
Three executive orders were signed by President Donald Trump last week. One of them is all about drug importation: measures already underway and new actions to help Americans buy more affordable prescription drugs from other countries. It has the potential to help many millions of Americans who are sick and tired of high drug prices or can’t even afford the medications prescribed to them.
The executive order states that the “Secretary of Health and Human Services shall, as appropriate and consistent with applicable law, take action to expand safe access to lower-cost imported prescription drugs by…”
Stopping right there, before listing the stated actions, you should know that it’s not accidental that the executive order uses the word “expand” when referring to safe access to lower-cost, imported prescription drugs.
Why is that?
Tens of millions of Americans have been personally importing meds from other countries for decades, despite federal prohibitions. And they are not prosecuted for doing so. It makes sense. They just want affordable healthcare. Licensed pharmacies in many other countries are safe and charge much lower prices than those in the United States. Since 2003, PharmacyChecker — through its online pharmacy verification program, drug price comparisons, and advocacy on lowering drug prices — has provided the necessary safety guidance to help people who choose to access affordable meds from Canada and other countries.
The actions on drug importation under the executive order will:
1) Grant waivers on prohibitions of drugs to individuals.
2) Allow for the re-importation of insulin.
3) Finish the federal rule on importation of drugs from Canada.
Number three was already happening. You may recall that Trump talked about allowing importation of drugs from Canada last year. A handful of states have passed importation legislation to allow state-licensed, wholesale pharmacies to import from Canadian wholesale pharmacies. A proposed rule was drafted by the U.S. Food and Drug Administration in December to finally allow wholesale (but not personal) drug importation from Canada. If you didn’t know, for many years, federal law, Section 804 of the Food, Drug and Cosmetic Act, has held that if HHS 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. Comments by the public were submitted to the FDA back in March. But nothing had happened since. States are patiently waiting for the HHS secretary to actually finalize the rule and press go. The executive order seems to now say that’s going to happen.
Whereas the FDA’s rule (mentioned above) said they are not expanding personal drug importation, Trump’s latest action says otherwise. To get into the weeds a little more here: the executive order references Section 804 (j)(2) which calls for waivers to permit personal drug importation. The executive order (forgive the pun) orders HHS Azar to grant the waivers “provided such importation poses no additional risk to public safety and results in lower costs to American patients.” That last part is potentially a poison pill, as it has been with Section 804, largely because the drug companies and their lobbyists have wrongly inflated “public safety” risks. But it’s doubtful it will be to the same degree because the law, as it pertains to personal drug importation is very clear that it should be allowed if it does “not appear to present an unreasonable risk to the individual.” That’s an entirely different standard than “no additional risk.” Buying medicine for personal use from Canadian pharmacies, for example, is clearly not an “unreasonable risk.”
The part of the executive order specific to insulin could be a game changer more immediately. Federal law essentially bans the importation or re-importation (if they are made here) of drugs in commercial quantities unless it’s the manufacturer of the drugs who is authorizing the imports, but for one exception: if the Secretary declares an emergency. The executive order seems to state that the price of insulin is an emergency, and that’s unambiguously true. The devil is in the details but one thing is for certain: Americans going to Canada and bringing back much cheaper insulin, which is technically prohibited under, are far more authorized to do so now.
PharmacyChecker has advocated for safe personal drug importation using properly verified online pharmacies for a very long time.
This isn’t a liberal or conservative, Democratic or Republican, effort. Government actions to expand use of safe personal drug importation will benefit the public’s health. It doesn’t matter if Trump or Biden does it.
The executive order signing ceremony comments added icing on the cake because of their clarity of what’s new here. HHS Secretary, Alex Azar, former president of Big Pharma company Eli Lilly USA, stated:
“You’re going to have a personal importation program, where individuals can get their drugs low cost from abroad.
And you’re going to have an insulin reimportation program so Americans can get their insulin re-imported from Canada at lower prices.”
Some folks have dismissed the Trump administration’s actions as election-year posturing that will not actually take effect and reduce drug costs, quick to point out that the Trump administration opposes the sweeping bill to lower drug prices passed by House Democrats in December. Who can blame them? But even if the executive order is an act of political desperation, let’s help all Americans benefit from it.
We shall see how this shakes out, but, for now, PharmacyChecker is fully supportive of the new Trump administration executive order permitting importation of lower cost prescription drugs for personal use.
We’d appreciate your thoughts to continue the discussion in the comments.