It came as something of a surprise when Health & Human Services Secretary Alex Azar announced that the administration was exploring the importation of prescription drugs to fight high domestic prices. Sec. Azar and Scott Gottlieb, MD, commissioner of the Food and Drug Administration, who also endorsed the new proposal, had previously opposed the idea.
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But drug prices in the United States have continued to rise and more than 80% of Americans say the government should take action. President Donald Trump has said drugmakers are “getting away with murder” and has angrily tweeted at companies about individual price hikes.
Although candidate Trump supported the idea of allowing patients to import medicines, since he was elected, he has not mentioned that option – which is strongly opposed by drug companies.
Now, determined to explore more avenues to curb price hikes, the administration is signaling that it is willing to consider what the industry regards as something of a nuclear option to address a recalcitrant problem. Carefully tailored to focus solely on specific situations in which a high-priced drug is made by only one company, it is finding support where broader proposals have failed.
“They’re approaching it incrementally and wisely, they’re focusing on prices where there’s a need,” said Dan Mendelson, the founder of health care consultant company Avalere and an official in the Clinton White House. “It is certainly more narrow than the way others have conceptualized it.”
Far from a blanket legalization of imported medicines, the working group Sec. Azar convened will study importation to combat sudden price increases in specific drugs. The focus is on temporarily bringing in cheaper similar or identical drugs to introduce competition into the U.S. market. The medicines must be off patent and have only one manufacturer here.
The secretary’s memo said the effort is designed to avoid the kind of overnight increases seen with Daraprim in 2015. That price hike was engineered by “pharma bro” Martin Shkreli, then CEO of Turing Pharmaceuticals. He purchased the rights to the single-sourced medication that treats parasitic infections and began charging $750 for a pill that formerly cost $13.50 and costs a little more than a dollar in much of the world. Turing was the only U.S. producer.
“This is a workable solution to a discrete problem,” said Ameet Sarpatwari, PhD, JD, an instructor in medicine at Harvard Medical School in Boston.
But those who support more sweeping importation policies decried the plan’s limited scope and suspected the announcement was part theatrics and part a threatening signal to drugmakers.
“This could just be a dog-and-pony show, where they’re calling in an expert group to explore avenues of importation – but when all is said and done, they find that they don’t want to do this,” said Gabriel Levitt, the cofounder of PharmacyChecker.com, a private company that verifies international online pharmacies and compares prescription drug prices for consumers.
“At that point, we’ll learn that the exercise was lip service,” he added. “Frankly, there’s a good chance that that is the case.”