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Update: ASHP statement released.
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
outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets:
“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.”