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.”
- Most pharmaceuticals sold in U.S. pharmacies are already foreign-made, imported products. The debate about legalizing drug importation often obfuscates this salient fact. The prices are so high because the drug companies, such as Eli Lilly, GlaxoSmithKline, Merck and Pfizer, control the distribution process from their foreign factories into the U.S. Those same drugs are priced much lower in other countries because other countries have price controls and are not so easily influenced by pharmaceutical company lobbying.
- The importation proposed is limited to single source drugs that are off patent, with the specific goal of stopping massive price gouging, by 1000% and up, not the normal but significant annual price hikes (10% plus) that are routine among big pharmaceutical companies.
- The idea floated by Azar should not be mistaken for reimportation or importation bills currently introduced. Legislative reforms to amend importation regulations generally seek to permit lower-cost, FDA-approved drugs, both those made here originally and then exported and those made outside the U.S., to be imported by wholesalers, pharmacies and/or individuals. Ironically, from a safety perspective, Azar proposes allowing imports of non-FDA-approved drugs, which are identified as foreign versions of FDA-approved drugs. Below are some examples of drugs that might be considered for importation under Azar’s proposal, noting the U.S. FDA-approved and the foreign version:
- Daraprim (Pyrimethamine). Price initially spiked by over 5000% (from $13.50 to $750). The U.S. version is licensed to Turing Pharmaceuticals (of Martin Shkreli fame). One foreign version, also called Daraprim, is made and/or marketed by GlaxoSmithKline.
- S. price: $750/pill, according to GoodRx.
- International online pharmacy UK, $2.53/pill, according PharmacyChecker.com.
- Gleostine (Lomustine). Price initially spiked by 1400% ($50 to $768/pill) but has come down considerably. The U.S. version is licensed to NextSource Biotechnology. One foreign version is licensed to BristolMyersSqibb, called CeeNU.
- S. price: $340/pill, according to GoodRx.
- International online pharmacy Canadian price: $18.26/pill, according to PharmacyChecker.com.
- Emflaza (deflazacort). The launch price in the U.S. was slated to be $89,000/year in 2017, but the drug company responsible, Marathon Pharmaceuticals, postponed the launch due to outrage about the price. The U.S. version was sold to PTC Therapeutics. One foreign version is licensed by Sanofi in the UK sold under the brand-name Calcort.
- S. price: $47.60/pill, according to GoodRx.
- International online pharmacy UK price: 77 cents/pill, according to PharmacyChecker.com.