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Wednesday, July 31, 2019

HHS Outlines Goals for Possible Future Canadian Drug Imports

The Trump administration on Wednesday outlined ideas for potential future steps toward allowing importation of certain drugs from Canada into the United States.
The US Department of Health and Human Services (HHS) did not release a firm timeline for making formal proposals on drug importation. In fact, a future publication of draft regulatory proposals would mark only a first concrete step toward opening serious debate on ideas being considered by HHS.
It thus is unclear when — or if — consumers may get access to cheaper drugs through Canada due to any of the ideas HHS discussed Wednesday with reporters.
Still, HHS Secretary Alex Azar on Wednesday did emphasize the Trump administration’s support for the concept of allowing consumers to buy cheaper versions of pharmaceuticals in Canada.
Changes in the business landscape have prompted a new look at the question of importation, Azar said. With expanding international operations, drug distribution firms and pharmacy chains may be able to manage secure cross-border transactions, he said.
“We owe it to the American people to keep challenging our assumptions, challenging our orthodoxies, challenging our systems,” Azar told reporters during a telebriefing.
He said the announcement on drug importation represents an important “mindshift” in the Trump administration. HHS wants pharmacy chains, states, and wholesalers to build the case for importation, Azar said.
“We’re saying here’s the roadmap. We’re open,” he said. “Work with us and convince us that you have a game plan that can work.”

Two Pathways

The outline HHS released Wednesday, which the department calls its “action plan,” envisions two regulatory pathways for safe importation of drugs.
HHS and the US Food and Drug Administration (FDA) could use a notice of process called notice of proposed rulemaking (NPRM) to authorize demonstration projects. These could be developed by states, drug wholesalers, and pharmacists and submitted for HHS review.
The would-be test groups would make a case to HHS about how they could safely import certain drugs from Canada that are versions of FDA-approved drugs manufactured consistent with the FDA approval.
In a press release, HHS said its planned future NPRM for the demonstration projects would also seek “significant cost savings” from importation for consumers.
And the FDA could use what is called guidance to give recommendations to drug makers who might want to import into the United States versions of those drugs they sell in foreign countries. In theory, this second pathway would potentially broaden the chances for importation to include medications like insulin used to treat diabetes, as well as those used to treat rheumatoid arthritis, cardiovascular disorders, and cancer, HHS said.

“Too Dangerous”

Drug makers seem unlikely to embrace this option.
The pharmaceutical lobbying group issued an immediate criticism of HHS’ outline. In a statement, Stephen J. Ubl, chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), called the aim of the HHS outline “far too dangerous for American patients.”
“Law enforcement has repeatedly warned that importation schemes could worsen the opioid crisis and jeopardize public safety,” Ubl said. “Moreover, Canadian officials have said that the policy is unworkable, and they will not risk shortages by diverting their medicine supply to the United States.”
John J. Leppard, an analyst with Washington Analysis, which advises investors about federal policy changes, wrote a Wednesday report on the HHS announcement. It was titled “Rx Pricing: The Red Herring of Reimportation & Supply Chain Implications.”
In the report, Leppard noted that the pharmaceutical industry is “unlikely to provide sufficient supply to foreign nations or pursue a demonstration project that would materially undercut its own domestic market and profitability.”
Leppard also observed that there is opposition in Canada to allowing more of the national drug supply to flow toward the United States. There have been reports of the nation’s medical system, Health Canada, preparing to take actions to ensure its citizens have uninterrupted access to the drugs they need, Leppard wrote.
“As reimportation has garnered greater attention in the U.S., Canadian officials have increasingly pushed back against the policy,” Leppard wrote.

Democratic Disapproval

The ranking Democrat on the health subcommittee of the Senate Finance Committee is also pushing back against the policy.
“This ‘action plan’ isn’t a real plan and lacks any real action. It sets up undefined ‘demonstrations’ that are limited in scope and it could take years to finalize rules, all while U.S citizens continue to pay the highest prescription drug prices in the world,” said Sen. Debbie Stabenow (D-MI), in a statement mailed to Medscape Medical News.
“If this Administration was serious about lowering drug prices, it should support passage of our legislation allowing Medicare to negotiate drug prices right now. The Administration should also support legislation I cosponsored, the Affordable and Safe Prescription Drug Importation Act, which will allow Americans to import safe and affordable prescription drugs,” she added.

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