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.(more…)Tagged with: Congressional House Ways and Means Committee, Rep. Gwen Moore
Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?
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.
That’s old news.
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 release:(more…)Tagged with: Martin Shkreli
Top Economist Says the FDA Should be Identifying Safe Foreign Pharmacies to Solve High Drug Prices in America
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.(more…)Tagged with: Donald Trump, Stephen Salant
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…)Tagged with: counterfeits, drug imports, FDA, international mail facilities, omnibus, opioids, Scott Gottlieb
Due to a little provision in the 2019 budget bill passed by Congress today, fewer Medicare enrollees may need to look online to international pharmacies for lower costs. That’s because the Part D discounts mandated under Obamacare are being phased in a year earlier. These are discounts provided to enrollees who fall into the Medicare Part D coverage gap “the “donut hole”.
Without the new provision, people in the donut hole would be responsible for around 50% of the cost of their medication until 2020, when they would only need to cover 30%. Now they will only need to cover 30% in 2019 – a year early.
This is a small win but perhaps it was a consolation prize. Regardless, some drug price relief is always welcome. It’s the drug companies who are forced to cover these discounts so they’re probably none too happy about this. On the other hand, maybe there was a backroom deal. The Creating and Restoring Equal Access to Equivalent Samples Act (CREATES), which would have helped lower-cost generics come to market faster, was slated to be a part of this bill. CREATES had massive support from groups on the left and the right, but it was knocked out of the final bill.
I’m glad that older Americans get a small discount next year on prescription drugs, but I have the feeling we got thrown a bone.Tagged with: creates, Medicare Drug Plans, Part D
Last month, I published an op-ed in The Guardian in opposition to Alex Azar for Secretary of Health and Human Services. In advance of the Senate Finance Committee Hearing tomorrow over his nomination, I’m publishing my article in its entirety below.
Recently, the president announced Alex Azar as his nominee to lead the US Department of Health and Human Services, saying: “He will be a star for better healthcare and lower drug prices!” People like me – experts in drug policy and advocates for lowering drug costs for American patients – know that nothing could be farther from the truth.
On average, Americans pay twice as much for life-saving drugs as consumers in other developed countries. It doesn’t have to be this way, but unfortunately, Azar might think so.
On Wednesday, Azar appeared before the Senate Health, Education, Labor and Pensions committee. While he stated his commitment to lowering drug prices, he declined to support the two solutions that would have the greatest impact on patients. In fact, he and his company have vigorously opposed policies that would make healthcare more affordable for the rest of us. (more…)Tagged with: Alex Azar, Eli Lilly, HHS, levitt op-ed, the guardian