Biden's prescription drug pressure from the left

The Biden administration is going to be under intense GOP scrutiny next year as it implements the drug pricing components of the Inflation Reduction Act.

• But it’s also likely to be under pressure from Democrats in Congress who want to see more executive action to reduce drug prices well before the law goes into effect.

Between the lines: Democrats have achieved their decades-long goal of allowing Medicare to negotiate drug prices last Congress, but that’s not enough for many of them.

• These members haven’t been shy about what they want. Many are pushing for the administration to exercise march-in rights and crack down on what they regard as patent abuse.
• The IRA gave the administration political cover to take its time on some of these items, and obviously that legislative process was an enormous effort in and of itself.
• But once Republicans take over the House in a few short weeks, legislative action on drug prices — at least the kind that progressives want — is over. That means everyone’s attention will be on Biden.

Driving the news: Elizabeth Warren and Pramila Jayapal wrote a letter last week to the Patent and Trademark Office asking for an update on “its efforts to hold pharmaceutical companies accountable for anti-competitive business practices.”

• Don’t let the word “patents” put you to sleep. This has been bubbling up as a huge factor in the drug pricing debate, as critics say pharmaceutical companies game the patent system to keep competition off the market and thus maintain the ability to charge monopoly prices.
• The drug industry disputes this characterization and argues that patents are key to encouraging innovation, including enhancements to products already on the market.
• More than 100 Democrats wrote to HHS in June urging it to use controversial patent licensing authorities — including march-in rights and compulsory licensing — to lower the prices of some drugs.
• The drug industry says that use of march-in rights "would have a chilling effect on American innovation."

Yes, but: 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.

What they’re saying: Last week, Axios asked Christen Linke Young, deputy assistant to the president for health and veterans affairs on the Domestic Policy Council, if she expected action on any of these policies being pushed by members.

• “I don't want to get ahead of any deliberative process inside the agencies. 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,” she said.
• “First out of the gate, I think we'll see some work from the [CMS] Innovation Center and a little bit of charting a course there on the Medicare and Medicaid payment side,” she added, referencing an executive order from the fall directing HHS to consider new payment and delivery models.
• Payment models may placate progressives for a little while, but it’s hard to see them accepting that on its own.

The bottom line: Axios asked John Yarmuth, who's retiring, if he thinks some members will be frustrated if Biden doesn’t take more executive action on drug prices next Congress.

• His response: “Absolutely.”