This past week, to lower drug costs, a bill was introduced in the Colorado legislature – SENATE BILL 21-123 – to allow drug imports from countries other than Canada. Colorado, which passed a law in 2019 allowing drug importation from Canada, apparently wants access to even lower cost drugs than Canada can offer. It’s also a way to address the real obstacle that Canada’s population is only 11% the size of the U.S. population and excess drugs supplies are limited. State of Reform does a nice job covering this bill, but this post gives some underlying and important history.
I applaud Colorado for this move, but there’s a little problem. Existing law, as found in the Medicare Prescription Drug Modernization and Improvement Act of 2003 (MMA), only allows wholesale drug importation from Canada (if safety and savings are certified by the HHS Secretary). Before there was the MMA, however, there was the Medicines Equity and Drug Safety Act of 2000 (MEDS Act). In fact, it was the MEDS Act that first added Section 804 to the Food, Drug, and Cosmetic Act calling for new importation regulations to help lower drug costs, and it was much larger in geographical scope.
The MEDS Act called for importation “from a country, union, or economic area that is listed in subparagraph (A) of section 802(b)(1) or designated by the Secretary, subject to such limitations as the Secretary determines to be appropriate to protect the public health.” Translating that into normal language, the MEDS Act would allow imports from Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa; or countries of the European Union. The rough estimate of the combined population of those countries is over 750 million, a large enough market to handle new drug imports from the United States. The MMA took a sledgehammer to the MEDS Act by making Canada the only eligible country for wholesale importation.
Colorado’s new bill recognizes this limitation and makes it clear that the proposed expansion to countries beyond Canada for drug imports will require an amendment to Section 804 allowing the same.
There are a lot of states, 19, that have introduced drug importation bills; six have passed and four states have submitted programs to HHS seeking approval to begin importing. Real momentum occurred on drug importation under the Trump Administration in the form of a final rule implementing Section 804 and an executive order on drug importation. President Biden’s campaign policy platform supported drug importation, too, but it’s unknown at this time what direction the administration will take.
Technically, Section 804 already permits drug importation from countries beyond Canada but only for personal use – not wholesale importation – as long as the import doesn’t present an unreasonable risk. In fact, in the same legislation that includes the MEDS Act, there was the “Prescription Drug Import Fairness Act of 2000,” which stated:
“Patients and their families sometimes have reason to import into the United States drugs that have been approved by the Food and Drug Administration (‘FDA’).”
It was probably that language that led the drafters of the MMA, three years later, to allow for personal importation. On the state level, California’s new drug importation bill is the first to call for expanding safe personal importation from potentially many countries with strong pharmaceutical standards. There is no geographical limitation to personal importation in Section 804.
For this geographical expansion to occur for wholesale drug importation, federal legislation is needed. Perhaps Colorado’s new legislative move will encourage other states to follow suit. That may motivate Congress and the president, after all these years, to turn the MMA back into the MEDS Act.
