The American Society of Health-System Pharmacists (ASHP) is criticizing a proposed rule that would allow for the importation of certain drugs from Canada.
The intended rule, which was released on December 18 by President Trump along with the Department of Health and Human Services (HHS) and the FDA, proposes specific conditions that would “ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer,” according to the agency.
The draft guidance sets forth procedures for drug manufacturers to submit documentation demonstrating that the product offered for import from any foreign country is, in fact, an FDA-approved drug product, including that it is manufactured in accordance with the FDA-approved application.
States and certain other non-federal government entities will be able to submit importation program proposals to the FDA for review and authorization. “An importation program could be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity,” the agency said.
“Today’s announcement outlines 2 pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” HHS Secretary Alex Azar said. “These are historic actions by HHS and the FDA, and they represent the bold nature of President Trump’s agenda for lowering drug costs.”
However, ASHP is concerned about the safety of imported drugs, and doesn’t believe the proposed rule will effectively lower drug prices.
Since the size of the Canadian pharmaceutical market is only a small fraction of the US market, it is “unrealistic to believe Canada will be a significant source of low-cost drugs,” Tom Kraus, JD, vice president of government relations for ASHP, said in a statement provided to Drug Topics.
“We need a bipartisan solution to bring down drug prices for American patients. Importation is not that solution,” Kraus said. “While the concept of pharmaceutical importation may seem as simple as a US manufacturer making and shipping drugs to Canada, for example, and Americans purchasing them to be sent back to the US, the reality is more complicated. Importation potentially short-circuits the safety requirements that protect the American drug supply and is unlikely to result in signification cost savings for patients.”
ASHP has long been opposed to importing drugs from Canada due to safety concerns. “One of our main concerns with the safety of importation is potentially bypassing safety requirements intended to protect against contaminated or counterfeit medications,” Kraus said.
Kraus pointed to a 2016 National Association of Boards of Pharmacy survey, which found that 96% of pharmacies claiming to sell Canadian drugs are fake, so those drugs do not enter the legitimate Canadian supply chain. “We should not accept these risks, particularly when this approach is unlikely to yield meaningful cost savings for patients,” he said.
Although NCPA executives stated they are still reviewing the proposed rule, Ronna Hauser, vice president of policy and government affairs for NCPA, told Drug Topics that they do not see anything that “would make us feel more comfortable” with the minimum requirements for importation.
NCPA opposes any importation proposals that do not meet several minimum requirements for independent community pharmacies, including:
- An importation program shall permit small business community pharmacies to acquire prescription drug product from a foreign wholesaler or manufacturer at competitive prices not currently available in today’s US supply chain.
- An importation program shall require such product that is acquired from a foreign wholesaler or manufacturer to be in compliance with US federal labeling and quality requirements. “For example, the product must be in compliance with the Drug Supply Chain Security Act (DSCSA) in that the product must have the unique product identifier and trading partners must provide traceability data,” NCPA said in a document provided to Drug Topics.
- Given the importance of DSCSA-compliant distribution channels, an importation program shall not permit consumers from acquiring prescription drug product from a foreign entity.
- Given the vast benefits of brick and mortar pharmacies to promote patient’s medication adherence and combat product waste, an importation program “shall utilize the existing structure of the US pharmaceutical supply chain to dispense prescription drug products,” NCPA said.
- An importation program shall not impose additional financial burden on small business community pharmacies. For example, product labeling under the DSCSA is the sole responsibility of upstream trading partners, not the dispenser.
- An importation program shall promote wide access to prescription drug product and also promote consumer choice of where to purchase such prescription drug product at the pharmacy level.
- An importation program shall not subject small business community pharmacies to onerous accreditation and licensing requirements outside of those requirements already currently enumerated by state and federal law.
Comments on the proposed rule are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.
1. Trump Administration takes historic steps to lower US prescription drug prices [news release]. FDA’s website. https://www.fda.gov/news-events/press-announcements/trump-administration....
2. Importation of Prescription Drugs [Federal Register]. Published December 18, 2019. https://www.federalregister.gov/documents/2019/12/23/2019-27474/importat....