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Good Judgement; Bad Judgment on Personal Drug Imports

Here’s a kind of funny story to end the year with. I make a big deal on these pages about the decriminalized reality of personal drug importation. Federal law prohibits under most circumstances importing prescription drugs for your own use, but people are never busted for it. I’ve been around this a long time and I mean never. But that’s for personal use only. Recently, 20 U.S. air marshals in Dallas, Texas were disciplined for “smuggling” Viagra into the United States. They bought it at lower prices outside the U.S., brought it back, and gave it to their colleagues or sold it for a “small profit,” as reported in Yahoo News. So, are they in any real trouble?

It appears the answer is not really—at least not yet. The names of the air marshals are not public because they have not been charged with a crime. Some were suspended for a few days. One resigned. No one was terminated. However, two may be terminated based on “evidence uncovered during the investigation.” I would guess that those two were dabbling in the resale of stronger pharmaceuticals.

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PhRMA’s Lawsuit Against Section 804 Ignores Statute’s Permissive Position on Personal Importation

In its lawsuit to stop wholesale drug importation programs that could help lower U.S. drug prices, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) may be stepping on its toes in helping to allow more personal drug importation. Last month, along with co-plaintiffs Partnership for Safe Medicines (PSM) and Council for Affordable Health Coverage (“CAHC”), PhRMA sued the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to invalidate the certification by the HHS Secretary Alex Azar that drug importation from Canada is safe and will achieve savings for the American consumer.

In late September, Secretary Azar, in a final rule, certified that importing drugs from Canada, subject to Section 804 of the Food, Drug and Cosmetic Act (Section 804), 21 U.S.C. 384, Part L, poses “no additional risk to the public’s health and safety” and will “result in a significant reduction in the cost of covered products to the American consumer.” Those were the two certifications needed to allow a new wholesale drug importation channel.

Section 804 clearly distinguishes between wholesale (“commercial”) importation (subsections b-h) and personal importation (subsection J). As explained below, the standard for allowing personal importation is different. While PhRMA does not want either wholesale or personal importation to lead to lower drug prices, certain legal arguments it employs in its lawsuit may help the cause of expanding personal drug importation. Namely, personal drug imports can be permitted if they don’t pose an “unreasonable risk” to the patient; not so for wholesale imports (drugs that are resold). PhRMA ignores this.

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Canada’s Order Against U.S. Drug Imports to Prevent Shortages Directed at Wholesale Not Patient Purchases

Canada issued an interim order on Friday, November 27, preventing drug establishments from exporting products that would risk causing domestic shortages. The press release with quotes from Health Minister Patty Hajdu may be more digestible than the official order.

As I see it, Americans who rely on buying less expensive prescription drugs from Canada should not be too concerned about this new development. The order is directed at companies who distribute drugs via wholesale channels, not pharmacies that dispense drugs directly to patients. Patients in the U.S. with a valid prescription who safely order drugs from pharmacies in Canada do so through licensed retail pharmacies not wholesalers.

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New Section 804 Drug Import Rule Does Not Allow Foreign Versions of FDA-Approved Drugs

The new federal rule on drug importation from Canada, drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. I’m writing this in response to a paper written by Thomas J. Bollyky and Aaron S. Kesselheim called “Reputation and Authority FDA and the Fight over U.S. Prescription Drug Importation.” Some people who read their paper may be confused.

Kesselheim and Bollyky assert that there are “three avenues for legal importation of prescription drugs that are not FDA approved.” The first example is personal drug importation, the second is importation from Canada under the new federal rule, and the third is shortages. I will address the second. 

By “not FDA approved,” they must mean foreign-versions of FDA-approved drugs. After all, the law only allows for the sale of FDA-approved drugs within the United States. The new importation rule doesn’t change that basic fact.

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It Takes a (Global) Village to Manufacture Merck’s Proventil Inhaler

Importation of prescription drugs to help lower prices for Americans will remain a major issue no matter who is president next year. The more we know about where our meds are made (mostly not here) the less successful drug industry lobbying will be against lower-cost, imported medicines.

In some cases, it’s as simple as a drug sold at a U.S. Walgreens is made in a manufacturing facility in one foreign country. For example, type 2 diabetes drug Jardiance (empagliflozin) is made in Italy. Another drug that treats type 2 diabetes, Januvia, is a little more complicated. Its active pharmaceutical ingredient (API) is made in Italy, but that API is formulated into the finished drug in the UK.

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HHS Insulin Import RFP Misinterprets the Law: Reimportation vs Importation

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.”

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