By: Libby Baney and Matthew Rubin, Faegre Baker Daniels Consulting
On October 7, the United States Office of Management and Budget announced that it is reviewing draft guidance from the US Department of Health and Human Services (HHS) titled Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products.
Though details are not yet available, this is likely connected to Pathway 2 of HHS’ Safe Importation Action Plan released in July 2019. Pathway 2 intends to provide domestic pharmaceutical manufacturers the ability to re-import FDA-approved prescription drugs sold in other countries through the creation of a new national drug code (NDC), labeling, and identification in compliance with the Federal Food, Drug and Cosmetics Act. Based on this recent White House announcement, we anticipate the draft guidance on Pathway 2 to be released soon, likely before the end of the year.
Pathway 1 of the Action Plan is focused on wholesale importation of prescription drugs, a policy that President Donald J. Trump and Joe Grogan, director of the White House Domestic Policy Council, continue to tout as a priority. We anticipate that HHS will promulgate draft regulations on Pathway 1’s wholesale importation approach later this year, after which time there will be a public notice and comment period.
Stakeholders in the US and Canada have already expressed serious concerns about both Pathway 1 and Pathway 2, citing drug safety and counterfeit risks, the potential for further drug shortages in Canada, and the inability to reconcile either option with prescription drug tracing and distribution requirements of the Drug Supply Chain and Security Act.
In addition to this federal activity, states have already begun preparing their plans for wholesale drug importation in the event HHS creates a legal framework for states to do so under federal law. In August 2019, Florida became the first state to submit an importation plan to HHS. To go into effect, however, HHS would still need to determine that the state importation plans are safe, hence the Administration’s work on the Pathway 1 and the anticipated wholesale importation draft regulations.
Also, in mid-October, Colorado – which, like Florida, passed a wholesale drug importation law in 2019 – released two new requests for information from wholesalers and pharmacies regarding importation.
Despite known health and safety risks, millions of Americans still poll in favor of drug importation policies. As such, and especially as we near the 2020 elections, we expect states and the Administration to continue to push these policies forward. Given this, it will be especially important for pharmacy stakeholders to stay engaged in the process and submit comments to HHS on anticipated importation regulations.