US

Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren, PBM executives again appear unscathed after another Capitol Hill appearance, and the growing push to ensure the FDA’s rare pediatric disease priority review voucher program is renewed.

The US Medicare agency is creating a formal reconciliation process for new inflation rebates in Part B and Part D of the program.

The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no longer be justified, the FDA said. The terminated panel’s responsibilities will be integrated into the Vaccines and Related Biological Products Advisory Committee.

But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during session on meeting management best practices.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

The CDC’s ACIP again punted a decision on whether to make a pneumococcal vaccine available to all adults 50 and older amid concerns over cost and equity tradeoffs, as well as unknowns about the length of vaccine protection. 

Second generation combination products may become more appealing as companies navigate the complexities of the Medicare price negotiation program.

The Oncologic Drugs Advisory Committee urged the FDA not to delay Imfiniz’s perioperative NSCLC indication, while also unanimously pushing for better trial designs in lung cancer and all resectable tumors.

The FDA’s experience with product-specific guidances for generic drugs may impact biosimilar industry decision-making, but the program has improved in recent years.

As the reauthorization deadline nears, CDER and CBER leaders stressed that sunsetting the program would hurt pediatric rare disease development, while endorsing a new Democrat-proposed stick for rare disease research. 

The Alliance for Safe Biologic Medicines urged restraint when considering FDA findings suggesting switching studies may not be as vital to support interchangeability.

Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.

The agency wants sponsors to start with three core symptoms common across cancer therapeutics and then add more treatment-related adverse events from item libraries based on a drug’s mechanism of action and other factors.

The House Oversight Committee held its third hearing on pharmacy benefit manager reforms in 14 months, but could not elicit an admission from executives that they are responsible for increasing drug prices.

The Oncologic Drugs Advisory Committee will vote on a product agnostic question related to perioperative trial designs during a 25 July meeting after discussing whether AstraZeneca needs an additional trial for its Imfinzi perioperative regimen in non-small cell lung cancer.

Shuren is retiring after 15 years as head of the FDA Center for Devices and Radiological Health.