Biden's drug pricing decisions aren't over
The Biden administration faces a host of high-stakes decisions on prescription drug costs over the next several months, accompanied by pressure from congressional Democrats eager for a sequel to pricing components in the Inflation Reduction Act (IRA).
The big picture: Democrats just delivered on their decades-long promise to allow Medicare to negotiate drug prices. But that legislative victory kicked off a series of difficult decisions the administration will have to make as it decides how much further to go addressing costs.
State of play: Democratic members of Congress have been explicit about what they want to see next, including the first-time use of government authorities to take over patents on expensive drugs in order to lower prices.
- Republicans, for their part, have made it clear that they plan to closely monitor the administration's implementation of the IRA's drug pricing provisions — and it's widely expected that someone will eventually take the administration to court over the law.
- Outside groups are agitating for the administration to take a more aggressive approach in making COVID tests and treatments available globally, by expanding a waiver to the World Trade Organization's intellectual property protections.
- And a new Alzheimer's drug could be approved within weeks, forcing Medicare to make difficult coverage decisions that could balloon the agency's drug spending.
Driving the news: Some big decisions have been pending for awhile.
- NIH has been reviewing a petition to use "march-in rights" to lower the price of Xtandi, an expensive prostate cancer drug, for more than a year already. On Dec. 1, the agency wrote in a letter to cancer patients who made the request that it's "currently coordinating with HHS to review and assess the information" in the petition, as STAT reported last week.
- The U.S Trade Representative earlier this month announced a delay of a decision on whether to support an expansion of the waiver for another six months.
The other side: The pharmaceutical industry and its allies have said that undermining patents — either through march-in rights, the WTO waiver or patent reform — will endanger innovation.
- "Expanding the TRIPS waiver to include COVID-19 treatments — as some WTO members wish to do — would jeopardize American innovation and our ability to prepare for future pandemics," PhRMA has argued.
- It has said that the use of march-in rights "could have a grave impact on the pipeline of new treatments and cures."
What they're saying: "The president has been clear that he thinks Americans pay too much for prescription drugs. ... This area remains a priority for us and one we're going to continue to look at," Christen Linke Young, deputy assistant to the president for health and veterans affairs on the Domestic Policy Council, said at an Axios event last week.
- She pointed to an executive order from the fall directing HHS to consider new payment and delivery models. A report on model options is due next month.
The bottom line: The administration is ultimately trying to strike a balance between lowering drug prices and encouraging medical innovation. No matter what it does, it's going to be accused of failing at one or the other.
- It could even be accused of failing at both, if it manages to anger both Democrats and Republicans.
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