The US Department of Health and Human Services (HHS) and the FDA are publishing a Safe Importation Action Plan outlining a pair of potential pathways with the goal of laying a foundation for the safe importation of certain drugs originally intended for foreign markets. In a prepared statement, HHS Secretary Alex Azar said these pathways will be explored as potential ways to lower prescription drug prices and reduce out-of-pocket costs for patients in the United States. 1

However, some pharmacists and other health care professionals have expressed opposition to the plan, citing patient safety and other concerns.

According to HHS, the 2 pathways would:
  1. Authorize demonstration projects developed by states, wholesalers, or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada.1,2 These drugs would be versions of FDA-approved drugs that are manufactured consistent with that agency's approval. The notice of proposed rulemaking (NPRM) would include conditions to ensure the importation poses no additional risk to the public’s health and safety and that the demonstration projects would achieve significant cost savings to consumers in the United States.1
  2. Provide FDA recommendations to manufacturers of agency-approved drugs who seek to import into the United States versions of those drugs they sell in foreign countries.1,2 Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. To use this pathway, the manufacturer or entity authorized by the manufacturer would establish with the FDA that the foreign version is the same as the United States version and appropriately label the drug for sale in this country. HHS says this pathway could be particularly helpful to patients with significantly high cost prescription drugs and would potentially include insulin and medications used to treat rheumatoid arthritis, cardiovascular disorders, and cancer.1
The Action Plan announced Wednesday is a follow-up to work that HHS and FDA have done together to explore solutions to improving access to lower-cost versions of drugs in the United States that have seen significant price increases or significant access challenges for patients. However, the new HHS-FDA plan has already received criticism by some drug experts.2, 3

The American Society of Health-System Pharmacists (ASHP) said the Action Plan “misses the mark and is unlikely to result in significant cost savings for patients,” in a prepared statement released Thursday. The organization said it objects to any importation approach that fails to maintain all safety requirements that protect the drug supply chain in the United States. 2

“Importation jeopardizes patient safety while failing to address the causes of high drug prices,” said Tom Kraus, ASHP Vice President of Government Relations, in a prepared statement. 2 "We will be watching the development of this plan closely to assess how the FDA is addressing safety concerns. It is unrealistic to believe that this plan will result in significant costs savings.  Policymakers should focus on workable solutions that lower costs, such as increasing generic competition and eliminating costly fees imposed by PBMs.”

The Healthcare Distribution Alliance (HDA) also expressed opposition to the Action Plan put forth by HHS and FDA. This organization said that although people in the United States are “rightly concerned” about prescription drug prices, importation policies would have “significant implications” for the safety and security of the pharmaceutical supply chain, as well as patient health. 3

Citing a recent study by the HDA Research Foundation, the organization said federal proposals to permit prescription drug importation would result in costly patient risks, additional regulatory oversight, and the operational challenges placed on the health care supply chain. 3

“The hard work already underway by supply chain stakeholders to implement the federal traceability law, the Drug Supply Chain Security Act, would be jeopardized,” the HDA said in its statement.3

“Pharmaceutical distributors support efforts to address the high cost of prescription drugs. But we firmly believe the administration should focus on policies that maintain the same high standards of safety that Americans have come to rely on. Importation runs directly counter to the efforts of many regulators, the pharmaceutical industry and congressional intent—and is simply not worth the risk,” the HDA continued. 3  
 
In a prepared statement, Acting FDA Commissioner Ned Sharpless, MD, explained that the FDA has a unique role to play in promoting competition that can help reduce drug prices and improve access to medicine for consumers in the United States. “We’ve been keenly focused on ensuring the importation approaches we’ve outlined pose no additional risk to the public’s health and safety. We know there are many operational challenges to address through each of these pathways, and are actively working through them as we look to formally announce these policies, with opportunity for public comment, in the coming months,” Sharpless said.

According to HHS, the FDA has delivered historic levels of generic drug approvals during the Trump Administration, with the Council of Economic Advisors estimating the savings generated from generic approvals in the first 18 months of the Trump Administration to be $26 billion. The Trump Administration’s drug pricing plan has delivered the biggest 12-month decrease in over 50 years of the prescription drug component of the Consumer Price Index, the official government measure of drug price inflation, HHS officials said in a press release. 1


References
  1. HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs [news release]. Washington, DC; July 31, 2019: HHS.gov. https://www.hhs.gov/about/news/2019/07/31/hhs-new-action-plan-foundation-safe-importation-certain-prescription-drugs.html. Accessed August 1, 2019.
  2. ASHP Believes New Importation Plan From HHS Unlikely to Provide Cost Savings [news release]. Bethesda, MD; August 1, 2019: ASHP. [email] Accessed August 1, 2019.
  3. HDA Statement on HHS-FDA “Safe Importation Action Plan” [news release]. Arlington, VA; July 31, 2019: HDA.org. https://www.hda.org/news/2019-07-31-statement-on-hhs-fda-safe-importation-action-plan. Accessed August 1, 2019.