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.”
In 2017, 801(d), was amended to ban the importation of foreign made FDA-approved drugs for commercial distribution, except if the manufacturer authorized it. Many people had thought that ban was in place from 1988-2017 on imported (not just reimported) drugs. It was not. Presumably, they added it to prevent people and companies – other than the manufacturers – from importing FDA-approved drugs at much lower prices and re-selling them. The amending language, however, did not ban imports for personal use, just re-sale.
As an aside: that change to the law took me by surprise. Pharma just sneaks stuff into bills any old time they want to. I wrote about it earlier this year.
Flash forward to the new Insulin RFP. Long story, short: HHS will allow the reimportation of insulin by entities other than the manufacturer based on a determination that it’s “required for emergency medical care” as called for in 801(d)(2). It specifically does not allow importation of FDA-approved insulin made elsewhere to be imported! Remember, these are drugs that are already imported by the drug companies themselves. The three major insulin products in the U.S. are Lantus (Sanofi), Humalog (Lilly) and Novolog (Novo Nordisk). Guess what. The Lantus and Novolog sold at U.S. pharmacies are made in Germany and Denmark, respectively. That leaves only Lilly’s Humalog for possible reimportation at lower cost because it is in fact made in Indiana. It is notable that Lilly’s former USA president is the one issuing this RFP: HHS Secretary Alex Azar. What a coincidence.
The crazy thing here is that it appears the authors of this RFP forgot or are ignoring the 2017 amendment to the statute.
The RFP states: “the statutory exception in section 801(d)(2) of the FD&C Act does not apply to insulin products manufactured outside of the United States.” That may have been true in 2016, but not anymore. Let us look the statute, as amended of course:
(1)(A) Except as provided in paragraph (2) and section 384 of this title, no drug subject to section 353(b) of this title or composed wholly or partly of insulin which is manufactured in a State and exported may be imported into the United States unless the drug is imported by the manufacturer of the drug.
(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 356e of this title or in the case of importation pursuant to section 384 of this title, no drug that is subject to section 353(b)(1) of this title may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.
(2) The Secretary may authorize the importation of a drug the importation of which is prohibited by paragraph (1) if the drug is required for emergency medical care.”
Do you see Section (2) right above? The Secretary can allow imports of drugs otherwise prohibited by paragraph (1) for emergencies. Before 2017, paragraph (1) was just (A) but notice there’s a (B). I know it is separated by paragraph in this block quote – but the statute says “paragraph 1” not the first paragraph or, paragraph (1)(A). Moreover, (2) refers to authorizing the importation of a drug – not the reimportation only of a drug.
The law is not ambiguous. Lantus and Novolog can be exempted for importation under this part of the statute and of course they should be.
You might ask if this even matters—this is all Trump window dressing anyway.
It does matter.
Even if they are making it difficult, they have opened the door to importation of more affordable prescription drugs. While we pursue longer-term legislative reforms to lower prices here, let’s use what we’ve got to get people access to insulin at much lower cost as fast as possible! I will leave you with a quote about insulin costs from the RFP:
“Americans pay significantly more for insulin than patients in other countries do. A recent HHS commissioned study found that the average gross manufacturer price for a standard unit of insulin in 2018 in the United States was more than ten times the price in a sample of 32 foreign countries. This cost differential presents an opportunity to pass savings onto Americans who are struggling to afford this life-saving medication. The high price of insulin and the corresponding potentially dire health consequences from rationing has become an emergency, particularly since the number of Americans diagnosed with diabetes continues to rise.”