A surrogate for the Trump campaign, Katy Talento, stated in an interview with Elisabeth Rosenthal, Editor-in-Chief, Kaiser Health News, that personal drug importation is allowed as a means for Americans to afford prescription drugs. I bring this up to make two points:
One, to remind the reader about the legal basis for the non-enforcement policy.
Two, to point out that during the Trump administration, the FDA has actually increased the numbers of prescription drug orders from other countries that it seizes, flouting the non-enforcement policy.
Ms. Talento’s remarks came in the form of an answer to a question that Ms. Rosenthal asked on behalf of Mike from Louisiana. Mike stated that he and his wife get their meds from Canada because they cost 50-75% less. Trump has been raging about drug prices for four years, but when are they going to see savings on their U.S. pharmacy shelves? Start at minute 42:00 in the video below.
The key remark by Ms. Talento is as follows:
“I’m so grateful that we have a policy of non-enforcement around…individual importation from Canada so that folks like Mike and his wife in Louisiana can continue doing what they are doing.”
Wrongly, the FDA has stated that – while the agency won’t pursue individuals for prosecution – it cannot simply allow personal imports so that Americans can afford medications. That’s not true. The law states:
“[the FDA] should exercise discretion to permit individuals to make such importations in circumstances in which (i) the importation is clearly for personal use; and (ii) the prescription drug or device imported does not appear to present an unreasonable risk to the individual.”
See: 21. U.S.C. 384(J)
One could counter that the law says “should” not “must,” but that doesn’t mean the FDA “cannot.” Others might point out that people are allowed to import, but only by physically bringing back a prescription drug from Canada. Not true. In this case, the questioner is from Louisiana. He doesn’t travel to Canada but probably orders his and his wife’s medications from a safe international online pharmacy. The law on personal importation cited above does not prevent mail order imports in any way.
This is not academic. Despite the Trump administration’s bullishness on drug importation, via executive orders, administrative Section 804 rule-making, and request for proposals on importation, the FDA has actually ramped up refusals and destructions of personal drug imports even when they “should” be allowing them.
Read Kaiser Health News: Amid Pandemic, FDA Seizes Cheaper Drugs From Canada
When we’re past this national nightmare next year, let’s get this right. It’s time to fully permit, not just allow through “enforcement discretion,” safe personal drug importation.
I disagree with Donald Trump on 95% of his policy decisions for the United States, but I like the 5% that relate to prescription drug importation.