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Insufficient regulation both on approval _and_ inspection of medical devices (thinking surgical applications and implantables for example) is as impactful on patient safety as drugs.
Worth reminding everyone that, on top of pharma and food, the FDA also regulates medical devices. Insufficient regulation both on approval _and_ inspection of medical devices (thinking surgical applications and implantables for example) is as impactful on patient safety as drugs.
Pity the old ways are
> You’ve died of dysentery
Reading "Bottle of Lies" by Katherine Eban, I'd argue that the collapse of the FDA was well underway before the current administration. The FDA was completely unable to regulate overseas drug manufacturers, resulting in many, many problems. Sincere attempts to inspect overseas drug makers with random inspections universally results in shutdowns, which cause politically unpopular drug shortages, making enforcement pol…
Earlier quoted context omitted.
Can you speak directly to what you're referencing, please?
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A few notables.
Ekterly (sebetralstat) – Treats hereditary angioedema (approved July 3, 2025)
Zegfrovy (sunvozertinib) – For NSCLC with EGFR exon-20 insertion mutations (July 2, 2025)
Widaplik (amlodipine + indapamide + telmisartan) – Single-pill hypertension therapy (June 5, 2025)
Tryptyr (acoltremon ophthalmic) – First in class dry-eye treatment (May 28, 2025)
mNEXSPIKE – Next-gen Moderna mRNA COVID-19 vaccine (May 30, 2025)
Emrelis (telisotuzumab vedotin) – Lung cancer (NSCLC) targeted therapy (May 14, 2025)
Yutrepia (treprostinil inhalation) – For pulmonary arterial hypertension (May 23, 2025)
Brekiya (dihydroergotamine autoinjector) – Acute migraine and cluster headache therapy (May 14, 2025)
Gomekli, Journavx, Grafapex, Datroway – Novel agents in oncology and pain management (early 2025)
Opzelura (ruxolitinib cream) – For vitiligo and atopic dermatitis (2022–2023)
Cobenfy (KarXT) – New schizophrenia medication targeting cholinergic receptors (Sept 2024)
Tarlatamab (Imdelltra) – First in class BiTE immunotherapy for small-cell lung cancer (May 2024)
Pegcetacoplan (Empaveli/Syfovre) – First complement C3 inhibitor for PNH & geographic atrophy (May 2021)
Leniolisib (Joenja) – First treatment for APDS immune deficiency (March 2023)
Nedosiran (Rivfloza) – siRNA therapy for primary hyperoxaluria (Sept 2023)
Retifanlimab (Zynyz) – PD-1 antibody for Merkel cell carcinoma (March 2023)
Are you aware of any of these?
the fda started with a noble mission but they've been getting heavy handed. or better cliched - slow handed with getting things certified.
you can solve this one or two ways: drop regulation or increase staffing.
so many institutions have unnecessary fluff, tremendous red tape (why do i need environmental review to stick a shed in my backyard??), our modern lives have too much regulation.
let's hope for the best.
the old system is holding back drugs.. there should have been more ozempics, more breakthroughs had the fda not been so slow. companies have a strong incentive not release bad drugs now.. lawyers are not cheap and law firms know money can be made.. it's not the 1930s anymore.. (okay it's still the 1930s in certain places of the world, that's a criticism)
typing this out hoping to convince any regulation reduction is good reduction, i thought of a third fda option: the fda let's everyone go hog wild initially but looks at the top consumed products and checks them for safety and efficacy each year.
I wish someone would convince RFK that prescription drug ads are bad for his brand of quack medicine. We could at least get rid of that societal cancer while the rest is torn down.
I’ve heard RFK say that it’s hard to ban TV ads for drugs. They are “speech” according to the 1st amendment, or something like that. Too bad. News broadcasts are full of those ads, and hence TV journalists are loath to investigate the people that pay their salaries.
i know this is a very political thing now but i've had friends (smart phd people who work industry) very annoyed at the fda for many years, and maybe this collapse is good! the fda started with a noble mission but they've been getting heavy handed. or better cliched - slow handed with getting things certified. you can solve this one or two ways: drop regulation or increase staffing. so many institutions have unnecess…
The FDA's creation was directly triggered by multiple mass poisoning incidents in the early 1900s.In 1937 over 100 people died from diethylene glycol-contaminated medicine, leading to the 1938 Food, Drug, and Cosmetic Act that significantly expanded FDA authority.