News & Views: 8/24 - 8/30

The House passed the $3.5 trillion budget resolution.

The resolution passed (220-212) after Democrat leaders agreed with moderate-Democrats that they would vote on the infrastructure bill by September 27. The budget resolution is the foundation for the upcoming reconciliation package that the Democrats plan to use to pass major policies, paid primarily by the savings generated from Medicare negotiation. Some of the progressive Democrats have voiced concerns that this compromise is troubling ahead of the reconciliation votes that will include major drug pricing and health care reform. To read the full article, click here.

Representatives Kuster (D-NH) and McKinley (R-WV) urged Secretary Becerra to take further steps in increasing access to prescription drugs for seniors.

In a letter, the Representatives call for two additions to the Contract Year 2022 Medicare Advantage and Part D Final Rule (CMS-4190-F2) including limiting the placement of products on the preferred specialty tier to only generics and biosimilars and setting a co-insurance percentage for the preferred specialty tier that is lower than the non-preferred specialty tier. The Representatives believe that these additional steps would strengthen the policy and reduce out-of-pocket costs for seniors. To read the full letter, click here.

CBO released an updated model to simulate new drug development under proposed legislation.

The model is intended to be used on policy proposals that are believed to have a substantial impact on new drug development. According to the working paper, the model depends on changes in expected profits or development costs to estimate the percent change of drugs in various stages of clinical trials. The new model shows Medicare negotiation would have a slightly smaller impact on new drug development than previously reported. To read the full report, click here.

The FDA announced a new pilot program that will expedite reviews and approvals for existing therapies that have novel uses that address a significant unmet need.

The Split Real-Time Application Review (STAR) program was included in the FDA’s 2023-2027 prescription drug user fee commitment letter. The STAR program is intended to increase access to existing drugs with new indications. Applicants will only be eligible for the program if the drug has significant clinical evidence that it could demonstrate improvement in the health outcomes of patients with an unmet medical need. The agency plans to create a website outlining the program by the end of 2022 and begin reviewing application by FY 2023. To read the full article, click here.

  • To read the full FDA letter, click here.

CIDSA Experts in the News

Rena Conti coauthored a Health Affairs Blog post on creating a resilient prescription drug supply chain. Conti and her colleague offer recommendations that address the current major shortcomings of the pharmaceutical supply chain. Most notably, they recommend a new interagency office within HHS to act as the lead entity in creating a resilient drug supply in the US. To read the full blog, click here.

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