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.
There is no end to my fascination over the new authorized pathways for wholesale and personal importation of lower cost drugs from Canada and many other counties. Last week, I wrote about the request for proposals from HHS on personal drug importation; the week prior, about the certification of Section 804 for wholesale imports from Canada. Today, I’m going to get very, very nerdy about the new Request For Proposals issued to allow for the reimportation of insulin. I am not sure the government could get more obtuse than this in trying to pretend to help people with importation while making it exceedingly difficult and limited.
Unlike the final rule on Section 804 of the FDCA and personal importation pathway opportunities also under Section 804, the Insulin RFP relates to Section 801(d)(1)(2) of the FDCA (21 U.S.C. 381). Veterans of this policy debate would recall this as the statute banning reimportation of prescription drugs. Notice the “re” is underlined.
From 1988 until 2017, Section 801(d), called “Reimportation,” banned any importation of a drug manufactured in the U.S., then exported, from being imported – or reimported – except by the manufacturer of that drug. The only exception, found in 801(d)(2), was if the Secretary declared that importing a drug is “required for emergency medical care.”
Americans have been personally importing medications for decades. In most cases, the reason is that the same drugs sold in the U.S. are much cheaper elsewhere. According to a recent JAMA article, about 2.3 million Americans import drugs to save money each year. The Kaiser Family Foundation pegged the number at about 20 million, total. This, despite the fact that, under most circumstances, such imports are prohibited. As explained below, under an executive order and a request for proposals by the U.S. Department of Health and Human Services and Food and Drug Administration (HHS/FDA), the door has been opened to formally allow personal drug importation, but the proposed parameters of the RFP ignore greater opportunities, savings and the law itself.
First, wholesale importation of lower cost drugs from Canada is now lawful. That is pursuant to Section 804 of the Food, Drug and Cosmetic Act. Such wholesale importations had been prohibited because the HHS Secretary had yet to certify that the importation would cause no additional public health risk and result in substantial savings for Americans. That certification, as required in Part L of Section 804, was provided by Sectary Azar last week.
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