HHS and FDA are taking steps to open the door to drug imports, soon after the Trump Administration said it was working on efforts to allow imports from Canada.
“President Trump has been clear: for too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices,” says HHS Secretary Alex Azar in a press release.
The new Safe Importation Action Plan is “the next important step in the Administration’s work to end foreign freeloading and put American patients first,” Azar adds.
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HHS and FDA’s new Safe Importation Action Plan outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets:
- Through a notice of proposed rulemaking (NPRM), HHS and FDA would propose to rely on the authority under current federal law (Federal Food, Drug, and Cosmetic Act (“FD&C Act”) Section 804) that would authorize pilot (or demonstration) projects developed by states, wholesalers, or pharmacists to be submitted for HHS review, outlining how they would import certain drugs from Canada. The drugs must be versions of FDA-approved drugs that are manufactured consistent with the FDA approval. The 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 the American consumer.
- Through guidance, FDA would provide recommendations to manufacturers of FDA-approved drugs that seek to import into the U.S. versions of those drugs they sell in foreign countries. 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 U.S. version and appropriately label the drug for sale in the U.S.
“This pathway could be particularly helpful to patients with significantly high-cost prescription drugs. This would potentially include medications like insulin used to treat diabetes, as well as those used to treat rheumatoid arthritis, cardiovascular disorders, and cancer,” FDA says.
In a statement provided to Drug Topics, B. Douglas Hoey, RPh, CEO of the National Community Pharmacists Association, says that the Administration’s proposal will be carefully assessed.
“We will be thoughtfully evaluating the administration’s proposal and its impact on community pharmacies and the patients we serve, although we have concerns about unintended consequences that could rise from importation such as patient safety, the possibility of standards lower than those established by the Drug Supply Chain Security Act, and disappointing cost savings that fail to deliver on the hope for better patient access,” says Hoey.
“NCPA is very concerned about the costs of prescription drugs and is committed to supporting solutions utilizing community pharmacists to help lower prescription prices at the pharmacy counter and improve patient care. Consumer access to affordable, safe prescription drugs and the pharmacy of their choice are vital to improved health and economic outcomes,” Hoey adds.
The Safe Importation Action Plan released by HHS and FDA last week “misses the mark and is unlikely to result in significant cost savings for patients,” says ASHP in a statement.
“Importation jeopardizes patient safety while failing to address the causes of high drug prices,” says Tom Kraus, ASHP Vice President of Government Relations. "We will be watching the development of this plan closely to assess how the FDA is addressing safety concerns.”
In addition, Kraus says 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.”