October 5, 2020
At the close of September, the Department of Health and Human Services (HHS) took action to implement two of President Trump’s drug pricing executive actions from July.
First, in response to President Trump’s Executive Order on Access to Affordable Life-Saving Medications, HHS issued its proposed rule to improve access to insulin and injectable epinephrine. Comments are due on October 28, 2020.
Additionally, HHS and the Food and Drug Administration (FDA) issued their final rule allowing states to submit plans to import certain prescription drugs from Canada. The final rule comes in response to President Trump’s Executive Order on Increasing Drug Importation to Lower Prices for American Patients requiring HHS to complete its rulemaking process on drug importation, among other things. Specifically, the final rule outlines how states, tribes, and—in some instances—pharmacists and wholesalers can facilitate the importation of certain drugs by developing and submitting two-year drug importation plans to FDA for review/authorization. In conjunction with the final rule, FDA issued a Safe Importation Action Plan and guidance detailing drug importation requirements.
Despite its persistent efforts to pursue solutions through importing prescription drugs, it seems likely that the final rule could be challenged in court by the pharmaceutical industry, which has long fought efforts on drug importation over concerns that it would disrupt the nation’s supply chain and result in an increase in unsafe medications entering the market.
Finally, in continuing its action upon the importation executive order, the Administration is seeking proposals on other pathways to enable prescription drug importation, including:
- Waivers for individual prescription drug importation (e.g., allowing situations where patients might be able, in limited circumstances, to import a non-FDA-approved drug for personal use); and
- Insulin reimportation (e.g., allowing insulin manufactured in the United States and exported to foreign countries to be reimported into the United States in a safe manner by a person other than the manufacturer of the insulin).
As we inch closer to the election, it is possible that we will continue to see an influx in regulatory actions seeking to formalize President Trump’s executive orders on healthcare.