Daily Briefing

Around the nation: FDA increases transparency for drug review process


FDA will start publicly releasing rejection letters soon after providing them to drugmakers, increasing transparency into the drug review process, in today's bite-sized hospital and health industry news from Arizona, Maryland, and Texas. 

  • Arizona: HonorHealth will acquire 18 clinics from Cigna's Evernorth Care Group, expanding the health system's footprint in the Phoenix area. Under the deal, which is expected to close in January, the Evernorth clinics will become part of HonorHealth's integrated system. "This acquisition enhances the services we offer and expands Valley residents' access to care," said HonorHealth CEO Todd LaPorte. Separately, Evernorth Care Group president Matt Totterdale said that the organization is "confident that HonorHealth is the right partner to continue our legacy and enhance care delivery for patients. We remain deeply committed to quality care, and we're dedicated to ensuring a smooth transition for both patients and our care team." According to Modern Healthcare, HonorHealth has been working over the last few years to expand its footprint across Arizona. Last year, the system agreed to assume operations of several Steward Health Care facilities in the state, and in 2023, it acquired the remaining stake in 26 FastMed urgent care centers. (Gliadkovskaya, Fierce Healthcare, 9/3; Hudson, Modern Healthcare, 9/2)
  • Maryland: FDA last week announced that it would start publicly releasing rejection letters soon after they were sent to drugmakers, increasing transparency into the drug review process. The agency also publicly posted 89 complete response letters (CRL) from 2024 and 2025 that had not been previously disclosed. CRLs outline FDA's specific concerns about a product's safety, effectiveness, and manufacturing. "This is a milestone day for the agency," said FDA Commissioner Marty Makary. "By embracing radical transparency — one of the guiding principles of this administration — we're giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust." In response to the decision, Brian Abrahams, head of global healthcare research at RBC Capital Markets, said that the "additional transparency is welcome, and provides a better look at the Agency's reasoning for drug rejections without having to rely solely on company communications." (Joseph/Silverman, STAT+ [subscription required], 9/4)
  • Texas: Last month, Judge Reed O'Connor from the Texas Northern District Court ruled against a Biden-era rule that would have restricted payouts from Medicare Advantage (MA) plans to agents and brokers. Although regulators cap the compensation from MA plans to independent agents and brokers, payments for third-party firms like field marketing organizations were uncapped. Last April, CMS finalized a rule to stop payers from paying additional fees that weren't subject to the compensation cap. In response, broker and marketing organizations sued to block to rule, saying that it exceeded CMS' regulatory authority and negatively impacted their business model. In July, O'Connor stayed the rule before later vacating it completely in August. According to O'Connor, CMS doesn't have the statutory authority to regulate contracts between health plans and their marketing partners outside of direct compensation, which means regulators aren't allowed to limit compensation for administrative services or decide broader contract terms. However, O'Connor did allow a provision in the rule that bars marketing organizations from sharing beneficiary information with each other without consent. (Pifer, Healthcare Dive, 8/20)

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