fda
Relaxing standards for biosimilars
The FDA on Wednesday announced plans to speed development of cheaper versions of brand biologics by lowering approval standards, Daniel Payne reports.
It was touted as a major announcement aimed at lowering drug costs. An expert tells me the policy is in line with how the FDA has been regulating biosimilars. Health secretary Robert F. Kennedy Jr. made the announcement from HHS headquarters with the heads of the FDA and the Centers for Medicare and Medicaid Services by his side. The announcement was for a draft framework for guidance that the FDA plans to release in three to six months.
Read more for FDA Commissioner Marty Makary's vision for biosimilar competition.
marketing
When a brand name becomes a generic term
In the latest episode of STATus Report, host Alex Hogan hit the mean streets of Cambridge, Mass., to quiz passers-by on their knowledge of GLP-1 brand names, shred some gnar, and learn the meaning of genericide.
It's an entertaining video — Alex really does do some tricks on his Rollerblades (sans helmet, I noticed) — but he also talks about a serious subject.
Ozempic has become synonymous with weight loss drugs. But Ozempic is approved for Type 2 diabetes, not obesity. When a brand name becomes the generic term for a category of product, the company is at risk of losing its trademark. Watch the video for in-line skating moves and to learn about the law.
medical debt
Weakening medical debt protections
New Trump administration guidance threatens to weaken protections for people with medical debt, KFF Health News' Noam Levey reports.
More than a dozen states have passed laws preventing medical debt from affecting consumers' credit, and many others are considering following suit.
But the Consumer Financial Protection Bureau asserts that federal law bars states from restricting medical debts from credit reports. Read more.
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