In the first
two weeks of January, the prospects for drug importation to help alleviate high
drug prices in the U.S. are looking good. Before summarizing recent
developments, I’ll just note that millions of Americans who can’t afford
medicines and want to save money continue to use personal drug importation,
despite the federal prohibitions. This includes physically traveling across the
border to buy from Canadian or Mexican pharmacies, through international air
travel, and ordering from international online pharmacies.
Lucia Mueller blogged about an important survey by the Campaign for Personal
Prescription Importation in which 94%
of respondents affirmed that cost is the #1 reason they rely on importation
through international online pharmacies.
Inquirer reported on Americans with Medicare falling through the
cracks on drugs dropped from formularies, particularly when they are prescribed
off-label, facing high costs and looking internationally for relief. As
reported, savings are even greater when Americans buy generic versions
overseas, of drugs that are still under patent domestically.
lot of buzz in Congress, states, and the White House on the issue of drug
importation right now. Hopefully, current laws will be amended this year to
make importation expressly permitted instead of merely tolerated.
(more…)Tagged with: Alex Azar, Daraprim, Donald Trump, Scott Gottlieb
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.”
Tagged with: Alex Azar, Daraprim, emflaza, gleostine, Roger Bate, Scott Gottlieb, single source
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: drug imports, FDA, international mail facilities, omnibus, opioids, Scott Gottlieb