Specialty Focus 10/21/26: FDA 'reset' continues + The new enforcement net

October 21, 2026 | Volume XV | Issue 42

FDA 'reset' continues with new plan for reviewing rare disease drugs

Healthcare Dive reports:

The Food and Drug Administration on Wednesday said it plans to “reimagine” the way it regulates therapies for rare diseases, looking at standards for individual conditions instead of a one-size-fits-all approach.

The “Rare Disease Framework Initiative” will review existing policies, seek input from patients and experts and come up with a “fit-for-purpose framework” for drug development and regulation, the FDA said. Officials plan to look at everything from pre-clinical trial engagement...

The new enforcement net: How CMS is catching non-compliant providers via expanded exclusion checks

Anita Browning, FRP | Florida Healthcare Law Firm

Historically, the HHS Office of Inspector General (OIG) acted as the sole gatekeeper for excluding bad actors from federal health care programs under Section 1128 of the Social Security Act. That dynamic has fundamentally shifted.

HHS Secretary Robert F. Kennedy Jr. officially delegated independent Section 1128 exclusion authority directly to the Centers for Medicare & Medicaid Services (CMS). Working alongside broadened revocation powers under 42 C.F.R. § 424.535, CMS is no longer just processing enrollment forms, it operates as a primary enforcement agency with “force multiplier” authority to cut off billing privileges and exclude entities entirely. The mechanics of how providers are being caught, where screening gaps exist, and the active enforcement push demonstrate why compliance programs must adapt.

Rather than relying on retrospective audits months after money has gone out the door, CMS has overhauled its detection infrastructure to catch questionable entities before claims are paid.

There is no magic diet

Irene "Rosie" Muratides, DO writes for ACSH:

Nutrition advice can sound very certain. Carbs are the problem. Fat is the problem. Seed oils are the problem. Sugar is toxic. Everyone should fast. Everyone needs more protein. Scroll long enough and almost any food becomes either a cure or a threat.

I studied Food Science and Human Nutrition before I became an internal medicine physician, and both taught me the same thing: nutrition rarely works in absolutes.

AI that predicts cancer survival

KVOA-TV

The leading AI tools that predict cancer survival are FAHR‑FaceAge and FAHR‑FaceSurvival, developed by Mass General Brigham and published in The Lancet Digital Health. These tools analyze a simple facial photograph to estimate biological age and directly predict mortality risk in cancer patients.

View video HERE.

Last Word

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