A version of this story also appeared in D.C. Diagnosis, STAT’s weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox.
WASHINGTON — Florida may very well be the first state in the nation to successfully import drugs from Canada, but it’s going to be some time before the pills start flowing to the Sunshine State.
About the Author Reprints
What is often missed in media coverage of drug importation is that the law, which permits importation of lower-cost drugs, applies a different standard to personal importation (people buying medicine directly from pharmacies in other countries). 21 U.S.C. 384 states that the Secretary (Health and Human Services) “SHOULD exercise discretion to permit individuals to make such importations in circumstances in which (i) the importation is clearly for personal use; and (ii) the prescription drug or device imported does not appear to present an unreasonable risk to the individual.” [CAPS emphasis added].
In contrast, Florida, as this article points out, must demonstrate “no additional risk” will occur from its importation plan to get the green light from HHS. It’s much easier to show that a personal import of a medication from a licensed pharmacy in another country does not “present and unreasonable risk to the individual.” With Americans looking for lower drug prices from Canada and other countries (See https://www.statnews.com/pharmalot/2019/08/14/canada-importation-drug-prices/): is HHS/FDA doing what Congress says it “should” do right now? Could they be making it easier and safer for Americans who choose to import medicine for personal use because they can’t afford it here?
To amplify my comment above: The Florida paper misrepresents the requirements of the DSCSA. In particular, it ignores the requirement that drug makers and repackagers add DSCSA-specified product identifiers to their packages. These identifiers must include a unique standardized numerical identifier on each package and case, per section 582(b)(2) of the DSCSA. The so-called safety measures outlined in the report are nothing more than window dressing to hide the missing elements of DSCSA compliance. See my STAT op-ed with Dirk Rodgers: https://drugch.nl/2JsYogg
Proponents of importation seem to believe that HHS/FDA can magically alter the law through regulation. I’m not a lawyer, but I don’t think it works that way.