On March 18, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA), along with the Partnership for Safe Medicines (PSM) and the Council for Affordable Health Coverage (CAHC), filed a citizen petition with the Department of Health and Human Services (HHS) Food and Drug Administration (FDA) asking them to reject New Mexico’s submitted import plan based on missing details.
PhRMA, PSM, and CAHC allege that the import plan may wind up making the imported drugs unsafe and not cost-effective, as it does not identify a foreign seller, importer, or FDA-registered repacker/relabeler for the drugs to be imported, and only contains a tentative list of drugs.
According to the petition, “New Mexico submitted a proposal so short on detail that FDA cannot assess whether the safety or cost criteria can be met.” The groups continue, noting that even if the plan identified a foreign seller, it offers “only the roughest back-of-the-envelope math (based largely on spending by health plans, not individual consumers) to support its claims that importation would reduce the cost of covered products to New Mexico consumers” and “ignores substantial start-up and administrative costs which will limit the State’s cost savings or eliminate any savings entirely.”
Additionally, the groups point out that the plan includes only a preliminary list of forty drugs with the expectation that New Mexico will conduct two additional rounds of drug reviews to determine whether operational considerations weigh against any of the drugs planned for import. The petition takes issue with the fact that seven of the drugs on the initial list (used to treat HIV/AIDS) must be stored at a temperature that does not exceed 30 degrees but the application provides “no guidelines for ensuring that each supply chain participant complies with the storage instructions included in each drug’s labeling.”
The groups also believe that New Mexico’s application suffers from “additional flaws and deficiencies that will harm manufacturers,” such as a lack of sufficient evidence that manufacturer trade secrets and confidential commercial information (“CCI”) will be protected.
Requested Relief
The groups are requesting that (1) the FDA not approve the plan, (2) the FDA disclose the identification of the foreign seller, importer, and FDA-registered repacker/relabeler, and (3) release the final list of drugs to be imported for public comment. However, they also note that “[t]he Application is so deficient on its face that we urge FDA to refuse to file it for review, much like it would for a new drug application that is deficient on its face in a way that precludes a complete review.”
Other Pending Actions
This most recent petition follows a January 2021 petition to block Florida’s import plan (which would allegedly “jeopardize patient safety”) and a lawsuit filed by PhRMA to stop the final rule implemented by the former Trump Administration. In this citizen petition, PhRMA, PSM, and CAHC argue that the application cannot be approved by the FDA because the Certification is invalid and the Final Rule is unlawful for reasons outlined in the litigation.