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
The heat is rising on the pharmaceutical industry because of high drug prices. The politically and economically middle-of-the-road editors at Bloomberg published an opinion piece this week called “U.S Prescription Drug Costs Are a Crime.” The gist in the article is that policy tweaks are not enough, pointing out that President Trump’s rhetoric on drug prices is much stronger that the reality of his actions. Major changes are needed, such as drug price negotiations in Medicare and making importation of lower-cost medication legal (something one in ten Americans already do, according to Bloomberg).
I love this article, but it doesn’t state clearly why drug prices are a crime. The answer is tens of millions of Americans aren’t filling prescriptions because of them each year. Many get sick and some even die because of them. For some cancer patients, it’s extortion. “Give me the money,” pharma says. “Or die.” Your money or your life.
Still, we all know that a crime is an act that violates laws of a governing authority as proven through due process of those laws. And our laws allow the pharmaceutical industry to charge the prices referred to as a “crime” in Bloomberg.
That said, there is litigation targeting drug companies, pharmacies, and insurance companies/PBMs for violating laws to keep drug prices high. Examples include insulin price fixing, collusion between health insurers and pharmacies, and pharmacy kickbacks to PBMs. However, to an extent not found in Australia, Canada, New Zealand and the United Kingdom, U.S. laws permit—even encourage—increasing drug prices out of reach for patients who need them. Lawful but unjust.
It gets sicker and more unjust: technically, a patient who re-imports a medication from Canada because it’s her only affordable option is subject to jail and fines. No, that’s never happened, but it’s despicable that the law makes it a possibility while drug prices continue to climb.
Justice and law, when it comes to prescription drug prices in America, are fully out of whack.Tagged with: bloomberg, collusion, crime, drug price negotiation, importation, kickbacks
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