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New Rules on Prescription Drug Importation Are Released – Or Are They?

By: Andrew Silverio, Esq.

On July 24, 2020, the White House issued an “Executive Order on Increasing Drug Importation to Lower Prices for American Patients” as part of a handful of executive orders aimed at drug costs (available at https://www.whitehouse.gov/presidential-actions/executive-order-increasing-drug-importation-lower-prices-american-patients/).  At first glance, the order seems to take sweeping steps to facilitate the importation of prescription drugs, but does any of it really represent a departure from existing law?  The order specifically orders the Secretary of HHS to take action in three ways:

  1. Facilitate waivers to individuals against the prohibition on importation, “provided such importation poses no additional risk to public safety,” pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA);
  2. Authorize the re-importation of insulin products upon a finding that doing so is required for emergency care; and
  3. Complete the rulemaking process started by the proposed rule (more information below) to allow importation of certain drugs from Canada.

As it relates to the first item, it’s clear that this does not represent any new law or authority.  Under section 804(j)(2) of the FDCA, “The Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices, under such conditions as the Secretary determines to be appropriate.”  This order is simply an instruction to utilize said authority, and it is not clear how or whether these waivers would differ from the existing FDA policy of enforcement discretion, which is quite broad and under which individuals are rarely prosecuted for importing prescription drugs for personal use.  The important caveat that the importation must pose “no additional risk to public safety” suggests that there may be no real change at all, as this is one of the biggest factors in the FDA’s existing policy of enforcement discretion, and the key element cited by the FDA and pharmacy stakeholders in pushing back against importation.

In regard to the second item, the specific inclusion of insulin is interesting, and perhaps represents the most significant element of this order.  The proposed rules outlined in 2019 by the FDA and HHS did not specifically include insulin (available at https://www.hhs.gov/about/news/2019/07/31/hhs-new-action-plan-foundation-safe-importation-certain-prescription-drugs.html), and the drug’s special storage and safety requirements are a barrier to its inclusion in existing avenues of importation.

While we’re on the topic of the proposed rule, the third item in the executive order is nothing more than an instruction to continue that rulemaking process.  So, is this order a dramatic step toward real federal action allowing drug importation, or just a token announcement that doesn’t really accomplish anything?  Unfortunately, it’s simply too early to tell, and we will have to wait and see what HHS does in response.  It is worth noting that when the proposed rule came out, it was met with harsh criticism from our northern neighbors, many of whom discussed potential action by the Canadian government to counter any such importation efforts in order to protect their own drug supply.  As such, action taken  by the United States in regard to Canadian drug importation won’t be the only factor in whether the practice ultimately becomes both legal and practical.