President Trump has stated that we will withdraw from the WHO, stating things about the organization that are not true – but also making legitimate criticisms. Do we quit the Department of Health and Human Services or the U.S. Food and Drug Administration because of their many failures? I mean on the political fringes of U.S. politics, anarchists and free market fanatics, you might find some support for quitting the federal government! But no, we need those government entities to protect and improve our health as a nation. There are many areas of public health, however, that we can’t deal with effectively alone as one country, and that’s where the WHO is really needed. Say, for things like… um, er, let me think… global pandemics.
I’m on a roll here, agreeing with drug companies on an issue related to affordable medicines access. Last week, I wrote about Gilead’s messaging about remdesivir, the new Covid-19 treatment permitted via FDA’s emergency use authorization: namely that you can’t buy remdesivir online: if you try, you’ll be scammed. Often drug companies lie or pay others to lie about buying drugs online from other countries, but not in that case. This week, I’m agreeing with the Pharmaceutical Researchers and Manufacturers of America (PhRMA) that the Trump administration’s new rule on drug manufacturer co-payment cards is not good for consumers because it will prevent the co-payment from counting toward deductibles, which means higher costs for patients.
If you didn’t know, drug manufacturers blanket medical offices throughout the country with their co-pay cards. These cards are sometimes immensely helpful to patients going to fill a prescription for a brand name drug, particularly when there is no generic substitute. How? Simple: the drug company picks up the tab!
The window for public comments on the FDA’s
notice on proposed rulemaking about drug importation under Section 804 of
the Food, Drug, and Cosmetic Act is closing on Monday March 9th – and I’m not
done writing! So, this post will be short and sweet but highly relevant. Of
course, lower drug prices in foreign countries are on my mind today – as they
often are. And they were also on the minds of the truth-sleuth masters over at
Politifact yesterday. The title gives away the answer already so go take a look
at how Politifact
checks out U.S. Rep. Gwen Moore’s (D-WI) statement: “Prescription drug
companies are charging Americans prices that are on average 4x higher than
what’s charged in other countries.” Or read on for the super quick explanation.
Martin Shkreli, who became famous overnight back
in 2015 for raising the price of Daraprim 5000%, is back in the headlines. Tagged
the “pharma bro” for the cavalier attitude he fronted about his greed, Martin
is actually currently behind bars. No, not for raising a drug price – otherwise
the jails would overflow with pharma execs – but for financial fraud related to
his work as hedge fund manager.
Now, years later, Shkreli, the company Vyera Pharmaceuticals
(formerly Turing Pharmaceuticals) and his colleague, Kevin Mulleady, are being
charged by the Federal Trade Commission and NY State Attorney General Letitia
James. With what? Pasted from the AG’s press
Stephen Salant, PhD, professor emeritus of economics at the University of Michigan and research professor at the University of Maryland has written a paper that I believe gives voice and pays respect to the millions of Americans who import or are on the verge of importing lower-cost medication using online pharmacies. Let me be clear: this guy is a world-renowned economist. An expert in applied microeconomics, Professor Salant is most famous for his work in the economics of natural resources and industrial organization. Over the past few years, he has turned his attention to the problem of high drug prices in America and how to solve it without decreasing investment in research and development to create new life-saving drugs.
I’ll articulate the basic points of Salant’s paper, as I
understand them, and then give some commentary.
The recently signed appropriations or “omnibus” bill to fund the federal government includes an additional $94 million (Section 778) for the FDA to screen and stop drug imports at international mail facilities (IMFs). That could mean fewer people receiving their prescription medications that they have ordered from Canadian or other international pharmacies.
As I wrote a couple of weeks ago, the FDA’s coming crackdown against opioids could be a cover for greater import refusals and destruction of imported medications. This new appropriation of $94 million is a lot of money. In the case of drug importation, that money could be used for good (intercepting opioid ingredients en route to drug dealers or addicts) or evil (refusing and destroying prescribed medication en route to a patient who can’t afford the drug here).
You can read the section of the bill showing the appropriation and what it’s for at the end of this post. It states that the money is for “necessary expenses of processing opioid and other articles imported or offered for import through international mail facilities of the U.S. Postal Service.” Those “other articles” include prescription medications from pharmacies in Canada and other countries. Since the FDA considers those imports illegal, at least under most circumstances, it can refuse them and even destroy them – but must first alert the patient who ordered them giving them due process to defend their prescription order. (more…)