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.
I’m a Democrat and voting for Joe Biden. It’s good to be honest. Biden supporters may view my blog post more favorably, while Trump supporters might be more skeptical. I can live with that. You can all fact check me. But ask yourselves: “have my prescription drug costs gone down over the past four years”? If you want to respond in the comments, please do so politely. About 25% of Americans, many tens of millions of people, say they have a hard time affording their meds. As I mention below, we should all get along on this issue. It’s not only critical that we end the madness of high drug prices in America, but let’s unify when we agree!!
My quick and dirty position point here is that most of Trump’s efforts to lower drug prices have either failed and/or are simply political window dressing to help him get elected. Before my fellow Democrats turn up your noses, just know that Obama promised to take on Big Pharma, too, but he did not. For a positive spin, Trump’s bashing Big Pharma rhetoric may have future political reverberations on the Republican party in favor of real actions to lower drug prices.
The highest score in the Prescription Justice Congressional Report Card on Drug Prices – 100 – goes to Representative Jan Schakowsky (D-IL), with a grade of A+. The only other A+ in the House goes to Rep. Perter Welch (D-VT), who landed a score of 99.5.
In simple terms: Rep. Schakowsky gets the high score because she was incredibly committed, active and vocal about lowering drug prices – and barely takes money from drug companies: just over $1000. If all members of Congress hopped on the drug price lowering bandwagon just like Rep. Schakowsky, the crisis of high drug prices in America would end.
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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A source for news and analysis about drug prices and safety, online pharmacies and personal drug importation, published on behalf of American consumers.
