Welcome to the FiercePharma political roundup, where each Monday we highlight developments in Washington, D.C., and elsewhere that could affect how drugmakers operate.
Even as impeachment proceedings and the coronavirus outbreak dominate headlines, drug-pricing threats are once again acute, rather than chronic—and that has drugmakers on guard, The Hill reports.
The Trump administration has ramped up work on the International Pricing Index, a cost-fighting measure that would tie Medicare's drug prices to those in other countries. Given that the U.S. pays the highest prices in the world, the pharma industry isn't happy with the idea.
And the idea's resurgence comes at a critical time: President Donald Trump's State of the Union address is scheduled for Tuesday, putting pharma and conservative groups on edge about a potential release then, according to The Hill. A group of 52 conservative organizations wrote to Department of Health and Human Services Secretary Alex Azar urging him to scrap the idea, and PhRMA circulated its own email to members.
Drugmakers are well aware of the threat already, though. In its recently released annual report, Novartis said it expects the federal government to keep drilling into drug pricing this year. Seventeen states had passed their own drug-pricing legislation by the end of 2019, and more is on its way.
Drug pricing remains a hot issue on the campaign trail, too. At a recent stop in Iowa, Massachusetts Democratic Sen. Elizabeth Warren said presidents have the power to lower drug prices without Congress, prompting a look into that issue from Kaiser Health News.
She’s right, the publication found. While executive moves would come with complications, the president has two legal powers to fight for lower prices—compulsory licensing and march-in rights under the Bayh-Dole Act.
With the first option, the government could choose certain drugs for which it believes prices are too high and break patents to spur cheaper competition. On the march-in rights, the government could only step in where it's done background research, owns intellectual property and believes medicines aren't widely available. That might apply to HIV-prevention drugs such as those sold by Gilead Sciences, an expert told KHN.
But both measures would be really tough to implement. Compulsory licensing has been possible internationally for years, and only a small handful of drugs have succumbed. The provisions in the Bayh-Dole Act have never been used.
Meanwhile, outside the government, U.S. cost watchdog ICER, or the Institute for Clinical and Economic Review, updated its value assessment framework for 2020. The updates include an effort to use more real-world evidence, changes to ICER's voting structure to incorporate a wider array of drug benefits and more.