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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.

In September, the Department of Health and Human Services (HHS) issued a new rule allowing for the importation of lower-cost prescription drugs from Canada, subject to many restrictions. Restrictions mostly prevent controlled or biologic drugs from import under the new rule. But do they also prevent “foreign versions” of FDA-approved drugs?

A drug is considered “FDA-approved” when the FDA approves the drug application of a manufacturer to market that drug in the United States. Kesselheim and Bollyky write:

“FDA approvals are specific to the information in the NDA or ANDA, including: the manufacturer, product, and its use; manufacturing location, formulation, source, and specifications of active ingredients; processing methods; manufacturing controls; labeling; and appearance.”

A foreign version of an FDA-approved drug is a finished pharmaceutical that has the active ingredient contained in the FDA-approved version and is approved in another country. That foreign market approval may be a drug that works just as well as the FDA-approved version, but it’s still not considered FDA-approved. Why?

  1. It’s a different formulation. FDA-approved Nexium is sold as a capsule; whereas European versions of Nexium are in tablet form: those are foreign versions of FDA-approved drugs.
  2. It was made in a plant that is not registered with the FDA for making that specific drug. An example is Daraprim (pyrimethamine), the drug made famous by Martin Shkreli for hiking its price from $13.50 to $750 a pill overnight. FDA-approved Daraprim is made in the U.S. The Daraprim sold in the UK for example is made in Europe by GlaxoSmithKline. It might be the exact same drug, including formulation, but GlaxoSmithKline did not apply to market the drug made in Europe in the U.S. That, too, is a foreign version of an FDA-approved drug, but much cheaper at about 5 bucks a pill in the UK.
  3. There’s a different inactive ingredient. In this case, a drug sold in Canada carries the same active ingredient and formulation as an FDA-approved drug. But the Canadian drug includes a different binder or filler as inactive ingredients. The Canadian drug is now deemed a foreign version of an FDA-approved drug.

Those examples of foreign versions of FDA-approved drugs cannot be sold inside the U.S. The new HHS rule states:

“To be eligible under the final rule, a drug needs to be approved by the Government of Canada’s Health Canada’s Health Products and Food Branch (HPFB) and, but for the fact it bears the HPFB-approved labeling when marketed in Canada, needs to otherwise meet the conditions in an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA). Essentially, eligible prescription drugs are those that could be sold legally on either the Canadian market or the American market with appropriate labeling.”

In other words, the drug must be an actual FDA-approved drug except for the labeling.

Kesselheim and Bollyky go on to propose and advocate a system of allowing the safe importation of high-quality foreign versions of FDA-approved drugs to tackle the price gouging on off-patent medicines. It’s a great plan!

Related: A Drug Importation Vocabulary Lesson: Misbranded and Unapproved Drugs