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.”
The economist and drug safety expert Roger Bate, PhD, affiliated with the American Enterprise Institute, published a short article this week, the title of which says it all: “Credentialed online pharmacies are so safe that peer review literature is no longer interested in results showing it.” The gist is that he and colleagues have been testing medications for several years, since 2008, as mystery shoppers ordering online domestically here in the U.S. and internationally for import. The research shreds the myths of the drug companies by presenting peer-reviewed data to derive what are called “facts” about the Internet and importation. The main fact proved is that importing medications, ones ordered online, can be equally safe as U.S. pharmacies.
In the studies from 2008-2016, 822 online medication orders were tested: 275 medications from 22 international online pharmacies verified by PharmacyChecker.com (12 of which are also verified by the Canadian International Pharmacy Association); 127 medications from eight U.S.-only online pharmacies verified by the National Association of Boards of Pharmacy and/or LegitScript.com, and the rest from websites with no verification.
Verified U.S. pharmacies sold zero counterfeits but one (out of 127) order of generic Cipro was substandard. Verified international pharmacies sold zero counterfeits but one (out of 275) order of generic Cipro was substandard. On a percentage basis, the PharmacyChecker.com-verified websites performed best (but that’s nitpicking). And for those of you thinking, well, one was substandard…that same medication is available at your local Walgreens or CVS. Read the research.
In contrast, online pharmacies with no verification (Dr. Bate calls it “credentialing”) sold eight counterfeits and 16 substandard drugs (out of 332 tested).
How about prices? When it came to brand name drug prices, the studies showed that credentialed international pharmacies were about 60% cheaper. (more…)