News & Views: 3/1 -3/7

March 8, 2022

President Biden briefly discussed high drug costs in his State of the Union address.

Most of his remarks regarding high drug prices revolved around capping the high cost of insulin. A policy that both Republicans and Democrats have voiced support for in the past; a $35 insulin cap is currently included in the reconciliation package as well as a standalone bill by Sen. Warnock. President Biden also urged Congress to work together to pass Medicare negotiation. To read his full remarks, click here.

Chairman of the House Energy and Commerce Committee, Rep. Pallone, introduced the Accelerated Approval Integrity Act of 2022.

The program has been a focus of policymakers and advocates since Aduhelm’s controversial approval; the bill was introduced shortly after the committee spoke with witnesses in February on the upcoming reauthorization of FDA’s User Fee Act. Rep. Pallone believes his bill will give the FDA the proper authority and oversight of drugs approved through the program, so that drugs that do not prove to have a clinical benefit may be taken off of the market in a timely manner. To read the full bill, click here.

A group of 13 lawmakers wrote a letter to PhRMA CEO Stephen Ubl on manufacturers’ recent significant price hikes.

The letter pointed to two recent studies that analyzed price hikes in January 2022. The first, by University of Minnesota PRIME Institute, found that manufacturers increased prices by 5.1%, on average for brand name drugs, for 72% of all formulations of the 100 top selling drugs. The other analysis, by Johns Hopkins University, found that manufacturers increased prices by an average of 3.9% for 16 of the top 20 selling Part D drugs. In response to these analyses, the senators and representatives asked PhRMA CEO Ubl to explain the manufacturers’ rationale. The letter requested answers by Tuesday, March 8. To read the full letter, click here.

CivicaRx announced plans to manufacture and distribute a $30 vial of insulin.

Civica is working with partners to make insulin affordable and accessible by patients. The insulin will be manufactured at the new Civica facility which is expected to be operational in early 2024 and will be capable of producing substantial quantities of insulin to meet needs in the US. Contingent on FDA approval, the insulin will be available as early as 2024. If passed, current bills that aim to cap insulin prices would reduce the cost of Civica’s insulin even further to 25% of the net $30 price for patients using insurance. To read the full press release, click here.

CIDSA Experts in the News

Rena Conti spoke with reporters at STAT News on the Northwest Prescription Drug Consortium. The group claims to have saved 1 million people nearly $100 million over the last six years in Washington and Oregon. Most recently, Nevada has joined the consortium in an attempt to further increase the group’s purchasing power. Conti explains that the more states, and subsequently people, join, the better prices they’ll be able to negotiate. To read more, click here.

Stacie Dusetzina spoke with reporters at CNN about Civica Rx’s newest announcement that they plan to manufacture $30 insulin. Dusetzina notes that Civica’s goal to “produce and sell insulin at very low prices could be an important disruption to the current system” that could truly benefit consumers. To read the full article, click here.

Ameet Sarpatwari and his colleagues from Arizona State University and PORTAL opined on the Bayh-Dole Act in a JAMA Viewpoint article. Specifically, they call on policymakers to update the 40-year-old law to better promote innovation and accessibility. To read the full article, click here.

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