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HHS and FDA Drug Importation Idea: Important Takeaways

Alex Azar, Eli Lilly

Azar is proposing a discussion about allowing imports of single-source drugs to lower costs

Yesterday, Health and Human Services Secretary Alex Azar announced that he was tasking FDA Commissioner Scott Gottlieb with forming a working group to explore how drug importation could be used to lower prices. See Gottlieb’s remarks on the proposal.

The crux of the proposal is very narrow. Azar is considering allowing imports of foreign versions of off-patent medicines that only one manufacturer (also referred to as “single-source” drugs) is selling in the U.S. market. That would be a drug without any competition where the company with the marketing license jacks the price. Keep in mind that he has simply called for a working group to discuss it.

I’m getting asked a lot of questions about this proposal and realize that many people, including well-informed journalists and policy professionals, don’t really get this.

People who already import medicines, through buying them online or carrying them home from Canada to save money may also be confused!

So, to help any and all understand what HHS and the FDA are considering when it comes to drug importation, below are some important takeaways. My general take, as noted in the Washington Post, is that it’s a step in the right direction (if it goes forward), and it could help educate the public about greater potential benefits to larger scale importation.

  • This is not legalizing buying cheaper, FDA-approved meds from retail pharmacies in Canada online or otherwise.
  • Millions of Americans already benefit from importing lower-cost, safe and effective medicines for personal use. They do this despite the existing federal prohibitions and scare tactics employed by industry-funded groups to deter such purchases. To do so safely, they stick to credentialed online pharmacies, such as those verified by PharmacyChecker.com. Today, Roger Bate, who is affiliated with the American Enterprise Institute, wrote: “All the FDA has to do is allow Pharmacy Checker to do its job and tell the American people about it.”

(more…)

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How are Americans importing more affordable medications?

online pharmacyIt’s widely known that Americans buy medications from Canada and other countries because the prices are much lower. What many people do not know is how people are doing this.

Even our foremost scholars on the issue of U.S. pharmaceutical prices don’t know. In an article published in the prestigious British Medical Journal (BMJ), readers are informed that:

“A modest proportion of U.S. citizens travel to Canada and Mexico to purchase lower priced prescription drugs.23

That footnote – 23 – links to a 2016 Kaiser Family Foundation Health Survey, which includes the question:

“Have you or another family member living in your household ever bought prescription drugs from Canada or other countries outside the United States in order to pay a lower price, or not?”

Eight percent of respondents said that they had, which is about 20 million Americans, but the survey did not ask how they did it.

The data is far from perfect. I looked at several data sources when I wrote a report in 2015 called Online Pharmacies, Personal Drug Importation and Public Health.  In one analysis of an FDA survey in 2012, I estimated that about six million Americans were purchasing medication from outside the U.S. over the Internet. I believe that figure is somewhat inflated. (more…)

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Daraprim’s Cost is Bizarre: So Save 99.8% Buying from a UK Pharmacy

Martin Shkreli trying to look cool

Martin Shkreli, founder and chief executive of Turing Pharmaceuticals. Not that cool.

It’s no secret that Americans are unhappy with Big Pharma. Pharmaceutical companies regularly rank as one of the least loved industries, right up there (or down there) with Big Oil and Big Government. And while this has usually been expressed as contempt towards the industry as a whole, recently the negative spotlight is shining brightly on one man: Martin Shkreli, hedge fund investor and drug company entrepreneur.

Soon after his company Turing Pharmaceuticals purchased the marketing rights to the drug Daraprim, Shkreli raised the price of Daraprim from $13.50 per pill to $750.00 per pill in the U.S. market where Turing has exclusive marketing rights. But that only affects America! Thankfully, consumers can purchase Daraprim, marketed by GlaxoSmithKline in the UK, from a verified international online pharmacy for as low as only $1.53 per pill. A mere savings of 99.8%.

Daraprim is used to treat toxoplasmosis, a disease that results from infection with the Toxoplasma gondii parasite. This parasite is very common (in fact it’s been estimated that 22% of U.S. population have been exposed to it and it usually infects people who have eaten undercooked meat, raw vegetables, or have handled cat feces. In healthy people it usually only causes flu-like systems. However this disease can cause severe complications in people with compromised immune systems, such as those with HIV or cancer, including brain lesions and seizures. The disease can also be very harmful to women who are pregnant, leading to a stillborn child or a child born with birth defects.

It’s not rare for medications that treat a rare disease or a small patient population to be expensive. Moreover, it’s understandable that pharmaceutical companies want to recoup the extensive costs of developing a drug and make a profit, although Big Pharma’s lust for profits appears insatiable. But let’s take a deep breath…Daraprim is not some new wonder drug. It was originally developed and marketed by Burroughs Wellcome and patented back in 1953 (the patent expired in the 70s). A relatively inexpensive drug, it was long manufactured by GlaxoSmithKline, until that company sold the U.S. marketing rights to CorePharma in 2010. Impax Laboratories later bought CorePharma, and turned around and sold the rights to the drug to Turing.

At that point Mr. Shkreli and our friends at Turing decided to change how Daraprim was distributed. Hospitals, instead of going to a wholesaler, now had to order from Turing’s “Daraprim Direct” program. Patients, instead of going to their neighborhood pharmacy had to order from Walgreen’s Specialty Pharmacy. And since there is no approved generic in the United States, patients who need Daraprim face monopoly pricing, with no competition to Turing on the horizon.  Many people of all political stripes seem to be enraged over price gouging like this, because it seems like they’re getting the worst of corporate monopoly and government protectionism.

In order to get this medication, American consumers may need to look across the pond. As mentioned above, GlaxoSmithKline may have sold their U.S. marketing rights to Daraprim in 2010 but not in many countries around the world, such as England, where it’s sold for pennies to the pill!

It only seems fair, not to mention in the interest of public health, that an important drug like this, that’s listed on the World Health Organization’s List of Essential Medicines, should not be one subject to the twisted reality and bizarre rationalizing of hedge fund managers.

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