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.
Last week, 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.
This week, the Philadelphia 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.
There’s a 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.
Federal Proposals on Drug Importation
Affordable and Safe Prescription Drug Importation Act of 2019
The bill was introduced in both chambers, by Senator Bernie Sanders (I-VT) and Representatives Ro Khanna (D-CA) and Elijah Cummings (D-MD) . If passed, new regulations would be put in place to allow for the wholesale and personal importation of lower-cost prescription drugs from Canada. That would mean wholesale pharmacies and retail pharmacies could import prescription drugs from Canada for re-sale in the U.S. market. After a two-year period, such imports could be permitted by other countries as well. It would also mean Americans could lawfully fill their prescriptions with and import medication from licensed Canadian pharmacies by mail.
This bill was introduced last Congress as well. It is a worthy, ambitious and important piece of legislation to end the distribution stranglehold that drug companies are granted by the federal government. It provides for robust safety protocols to protect against substandard and counterfeit medication imports and adds stronger criminal penalties to deter rogue online pharmacies.
The Safe and Affordable Drugs from Canada Act
This bill was introduced by Sens. Grassley (R-IA) and Amy Klobuchar (D-MN) – and was one that the late Sen. John McCain tried hard to get through. It is a much simpler bill than Sanders’ bill described above. It envisions making it expressly legal for people in the U.S. to buy and import for personal use medicines from licensed Canadian pharmacies that are registered with the FDA. It basically makes legal most of the best practices found in the current personal drug importation that takes place.
State Proposals on Drug Importation
Vermont’s State Wholesale Drug Importation Program Next Steps
On December 31st, the Vermont Agency for Human Services finished a report on developing a wholesale drug importation program, as mandated under Vermont’s state legislature’s Act 133 and S. 175: An Act Relating to the Wholesale Importation of Prescription Drugs into Vermont. The law commits to creating a robust program in which registered Vermont pharmacy wholesalers can import FDA-approved drugs from registered Canadian pharmacy wholesalers in which significant savings for the state and consumers will result.
This program looks to Section 804 of the Food, Drug and Cosmetic Act (Title 21 U.S.C 384), which makes importation from Canada legal if the Secretary of Health and Human Services certifies that the drug imports would pose no additional risk to public health and safety and achieve significant savings. No HHS Secretary has provided such certification to date. Vermont, however, will be the first state to ask HHS to review a program, one that I believe clearly meets the standard of federal law.
The report estimated a large range in savings, $1-5 million, from the proposed importation program. The estimate was based on 17 drugs identified as candidates for lower-cost imports. The cost of creating and supporting the program was not accounted for in the estimated savings. A second report is forthcoming to take a hard look at the costs of regulation.
From a safety standpoint, it’s difficult to see how Secretary of Health and Human Services Alex Azar could reject the proposal. Under the proposed program, companies exporting and importing drug imports from Canada will essentially follow the same safety protocols for supply chain security that are currently required. The devil will be in the details of costs of regulation, but I’m pretty convinced the savings will be enough to make it difficult for Secretary Alex Azar to reject the program, considering he has put forward an importation plan as well (See below: Trump Administration Import Proposal).
Act 133 requires Vermont to issue its proposal to HHS by July 1,2019. We’re hoping for Vermont’s success. I’ll be closely monitoring Vermont’s program. For the record, the model for Vermont’s state law was developed by the National Academy for State Health Policy, as was the report discussed above.
White House Proposals on Drug Importation
Trump Administration Import Proposal
This past summer, HHS Secretary Azar, probably to the surprise of many, announced the creation of a task force on drug importation led by FDA Commissioner Scott Gottlieb. The scope of this idea is limited to off-patent drugs where competition is failing in the U.S. market. For details and analysis on this policy, see: HHS and FDA Drug Importation Idea: Important Takeaways.
I hadn’t heard much about this recently, but Morning Consult reported that someone who knows Azar believes it could happen this year.
Known as “single source” drugs, the drugs on which Azar is focused are subject to the worst price gouging in the United States. Daraprim, of Martin Shkreli fame, was the poster child. That drug’s price was jacked from $13.50 to $750 per pill overnight in fall of 2015. At that time, the GlaxoSmithKline version of Daraprim was selling in the UK for about six bucks a pill.
One of the most interesting components of this policy for me is that it is looking to import foreign versions of FDA-approved drugs. For years, the FDA has warned that foreign versions of FDA-approved drugs don’t offer the same guarantee of safety as the ones sold here. That statement is technically true. It’s not the “same.” In the case of the cheaper Daraprim noted above, the guarantee comes from the European Medicines Agency.
Safe Importation Already Exists
It must go repeated that we already use “drug importation” for our lawful medicine supply. Most pharmaceuticals sold in the U.S. are foreign-made. These policies, laws and regulations discussed above (and over the years) really have to do with removing the power of the drug companies to monopolize distribution into the U.S. so Americans can get the lower prices they charge elsewhere: and figuring out how to do it safely.Tagged with: Alex Azar, Daraprim, Donald Trump, Scott Gottlieb