There may be 'safe, select avenues for importation' that the U.S. government should consider, the HHS secretary said.
Health and Human Services Secretary Alex Azar made an announcement Thursday morning that seemed, at least at first blush, to contradict his claim two months ago that proposals to lower drug prices in the U.S. by importing product from Canada are "just a gimmick."
Azar had argued previously that drug importation would be ineffective and perhaps unsafe. But on Thursday he said there may be some circumstances in which importing drugs could be a useful tool in the Trump administration's effort to tamp down drug costs.
Azar directed the Food & Drug Administration to establish a working group to explore the possibility of permitting drug imports in a particular set of circumstances: when there's a significant price increase on a drug produced by a single manufacturer without the protection of patents or exclusivities.
This situation has happened a number of times in recent years with branded and generic drugs alike, he said. The price of Daraprim, for example, jumped more than 5,000%, from $13.50 to $750 per tablet, in 2015—more than six decades after the drug secured FDA approval.
"Safe, select avenues for importation could be one of the answers to these challenges," Azar said in a statement.
- Defensive tone: The HHS announcement took a defensive tone, saying both Azar and the president "have consistently maintained that HHS is willing to explore all ways to tackle the soaring price of drugs" while keeping patients safe and protecting innovation. The narrow application of the working group's mission "stands in contrast to proposals to import a broader range of drugs," the HHS announcement states.
- Support from a predecessor: Tommy G. Thompson, a former Republican governor of Wisconsin and HHS secretary under President George W. Bush, issued a statement praising Azar's move and emphasizing that it is a targeted tactic, not a general approach. "While importation doesn't make sense on a broad scale due to the inability of FDA to ensure safety, FDA should be able to carefully control the safety of importation in instances of clear abuse, and this will help patients," Thompson said. "This is a commonsense and pragmatic approach in instances where egregious business conduct harms patients."
- A short-term tactic: In his own statement, FDA Commissioner Scott Gottlieb emphasized the short-term nature of this targeted tactic. "Any policy that involves the importation of drugs would be temporary until adequate competition enters these categories," he said.
- Focus on safety: The HHS statement said medicines would not be imported if their safety cannot be guaranteed. "Importation will be limited to cases where drugs can be imported with adequate assurances of safety and effectiveness," the statement said.
The suggestion that such assurances of safety and effectiveness are possible undermines one of the arguments Azar raised in May against such importation policies.
"[T]he last four FDA commissioners have said there is no effective way to ensure drugs coming from Canada really are coming from Canada, rather than being routed from, say, a counterfeit factory in China," Azar said in May, according to his prepared remarks.
"The United States has the safest regulatory system in the world," he added. "The last thing we need is open borders for unsafe drugs in search of savings that cannot be safely achieved."
Editor's note: This story has been updated to include statements from former HHS Secretary Tommy G. Thompson and FDA Commissioner Scott Gottlieb.
—Steven Porter is an associate content manager and online news editor for HealthLeaders, a Simplify Compliance brand.
The HHS secretary had earlier this year seemed to dismiss importing any Canadian drugs, calling the proposals ineffective and potentially unsafe.
There may be certain circimstances in which drug importation could work, the HHS secretary added in a defensive announcement Thursday.
The FDA will form a working group to look into the possibility of using imports to combat drug price spikes in certain circumstances.