Food and Drug Administration (FDA) Blogs This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Don ’t Look to the Build Back Better Act to Reduce Insulin Prices
Michael F. CannonThe House ‐passedBuild Back Better Act (BBBA) purports to make insulin more affordable. As Cato adjunct scholarsCharlie Silver andDavid Hyman write inOvercharged: Why Americans Pay Too Much for Health Care:Insulin is a drug used by millions of Americans afflicted with diabetes. It is off‐patent and made by three companies, so it should be reasonably priced. It is not. The past two decades have seen stunning price increases. Short‐acting insulin, which cost about $21 in 1996, went for about $275 in 20 17. And…the prices went up in lockstep, even though there were two companies making sh...
Source: Cato-at-liberty - December 13, 2021 Category: American Health Authors: Michael F. Cannon Source Type: blogs

Merriam ‐Webster Needs To Update Its Definition of “Anti‐Vaxxer”
Jeffrey A. SingerPolitical polarization hinders progress against the COVID-19 pandemic.Political polarization may explain why, after former President Trump called the off ‐label use of the anti‐malarial drug hydroxychloroquine a “game‐changer” in the battle against COVID-19 (randomized controlled trials found that isnot the case), public health officials and the mainstream press appear uninterested in the off ‐label use of any other drugs as therapeutics against a COVID infection.For example, impressive data from randomized controlled trials show the off ‐label use of the off‐patent (...
Source: Cato-at-liberty - December 6, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Merck Antiviral Drug Moves Closer to Approval
Jeffrey A. SingerA Food and Drug Administration Advisory Panel justapproved, narrowly, the Merck antiviral drug Molnupiravir. This is just step one. We now have to wait for the FDA to decide on emergency use authorization.The U.K. approved Molnupiravir on November 4.Merck applied to the FDA for approval on October 11. Vaccines are the best long ‐term defense against COVID-19, but antivirals are the best first‐line defense, especially when new variants can develop that escape the immunity provided by vaccines.Rather than wait weeks for the vaccine to take effect, antivirals —like antibiotics—work immediately t...
Source: Cato-at-liberty - November 30, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

FDA-approved, Cybin-sponsored clinicial trial to measure ketamine ’s impact on the brain via Kernel Flow neuroimaging helmet
This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding,” said Dr. Alex Belser, Cybin’s Chief Clinical Officer… “Quantitatively measuring the brain within the context of a psychedelic experience is a promising frontier,” said Bryan Johnson, founder and Chief Executive Officer of Kernel. “With Kernel Flow, Cybin’s researchers can start putting numbers and quantification to subjective states of mind, including altered ones.” Kernel Flow uses pulsed light instead of continuous wave light to increase measur...
Source: SharpBrains - November 22, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Technology & Innovation Brain-Imaging Cerebral Cortex Clinical-Trial Consciousness Cybin drug development FDA human cognition Kernel ketamine neuroimaging neuroimaging helmet neurological activity placebo Source Type: blogs

An Encouraging Development for the Cause of Cannabis Legalization
Jeffrey A. SingerYesterday, U.S. Representative Nancy Mace (R ‑S.C.) introduced theStates Reform Act that would remove cannabis from the federal government ’s list of controlled substances, expunge federal criminal records related to nonviolent cannabis offenses, prevent the Small Business Administration from discriminating against state‐licensed cannabis businesses, and allow doctors practicing in the Veterans Affairs Health System to prescribe medicinal marijuana.In those respects, the proposed legislation has much in common with a bill introduced in the U.S. Senate by Majority Leader Chuck Schumer (D ‑NY...
Source: Cato-at-liberty - November 16, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Plumbing new depths of stupidity
Yep, stupid is the only word for it. And before I cut to the chase, to be clear, people can behave stupidly and hold stupid beliefs even without having the general characteristic of being stupid. This distinction is often lost on those accused. It can happen even to people with exceptionally high IQs.Note the dread Nobel disease.So, now that many people are facing vaccine mandates, the new fad is to get vaccinated and then" undo " the purported ill effects by various insane methods: In a TikTok video that has garnered hundreds of thousands of views, Dr. Carrie Madej outlined the ingredients for a bath she said will �...
Source: Stayin' Alive - November 13, 2021 Category: American Health Source Type: blogs

Building (Tobacco Smoking Rates) Back Better
Jeffrey A. SingerHouse Budget Chair John Yarmuth (D-KY)reportedly added a “nicotine tax” that will affect nicotine‐containing vaping products to the “Build Back Better” bill, currently under construction by House Democrats, as part of a manager ’s amendment. The nicotine tax amendment can be found onpage 1973 of what is currently a 2,135-page bill.Democratic legislators are seeking new ways to “pay” for the purported $1.75 trillion “Build Back Better” package, and it appears Rep. Yarmuth is willing to single out would‐be tobacco quitters for an extra part of the tab.Nicotine ‐cont...
Source: Cato-at-liberty - November 3, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

On physical activity, neuroplasticity, depression, screen time, neuromodulation and more
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring this time eight scientific reports and industry resources plus a few fun brain teasers. #1. Study finds ultimate hack to protect teen brains from harmful screen time: Exercise (and good role-modeling): “Girls who spent less than an hour on screens and boys who spent less than 90 minutes on screens were not negatively impacted by it. But at higher amounts of screen time, their life satisfaction dropped significantly—they were less happy with their lives, and it got worse the more time they spent … (the) study also found that teens who got more regula...
Source: SharpBrains - October 29, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Education & Lifelong Learning Peak Performance SharpBrains Monthly eNewsletter Technology & Innovation Aduhelm Brain Teasers CBT cognitive load cognitive-behavioral-therapy cognitive-therapy depression digital Source Type: blogs

Journalistic Balance Run Amok in the Matter of Aging
The implementation of journalistic balance is a self-parodying genre of writing. In the case in which the scientific community is working towards saving countless lives, by implementing therapies targeting the underlying mechanisms of aging, the paint-by-numbers journalist and editor duo will dutifully find a curmudgeonly figure who thinks that everyone should just get on and die, and put in a few quotes in order to balance the article. The piece here is an example of exactly this phenomenon; it is left as an exercise for the reader to identify the other popular media checkboxes lazily checked in the course of its few page...
Source: Fight Aging! - October 27, 2021 Category: Research Authors: Reason Tags: Daily News Source Type: blogs

Hearing Aids, the FDA, and Henry David Thoreau
David BoazThere ’s good news for people with impaired hearing: Hearing aids may soon be available over the counter, like reading glasses. But I was struck by something in this encouragingNew York Times report. The writer, Shira Ovide, is clearly enthusiastic about this new development. But notice her framing, first in the subhead of the article:Over ‐the‐counter hearing aids have the potential to showgovernment and tech companies at their best.And then throughout the article:These over ‐the‐counter hearing aids have the potential to prove that thebest efforts of government and technology companie...
Source: Cato-at-liberty - October 22, 2021 Category: American Health Authors: David Boaz Source Type: blogs

Regulatory Reactivity in FDA's Approval of the Alzheimer's Disease Drug Aducanumab (Aduhelm)
Yaniv Heled (Georgia State University), Ana Santos Rutschman (Saint Louis University), Liza Vertinsky (Emory University), Regulatory Reactivity in FDA's Approval of the Alzheimer's Disease Drug Aducanumab (Aduhelm), Regul. Rev. (2021): On June 7, 2021, the U.S. Food and Drug Administration... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - October 22, 2021 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

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Congress and the Food and Drug Administration should act to protect an important pathway for timely approval of cheaper generic versions of brand-name drugs. (Source: The Commonwealth Fund: Blog)
Source: The Commonwealth Fund: Blog - October 19, 2021 Category: International Medicine & Public Health Authors: Bryan Walsh Source Type: blogs

Six guidelines to navigate the Aduhelm controversy and (hopefully) help patients with Mild Cognitive Impairment and early-stage Alzheimer ’s Disease
The approval of a controversial new drug for Alzheimer’s disease, Aduhelm, is shining a spotlight on mild cognitive impairment — problems with memory, attention, language or other cognitive tasks that exceed changes expected with normal aging. After initially indicating that Aduhelm could be prescribed to anyone with dementia, the Food and Drug Administration now specifies that the prescription drug be given to individuals with mild cognitive impairment or early-stage Alzheimer’s, the groups in which the medication was studied. Yet this narrower recommendation raises questions. What does a diagnosis of mild cognitive...
Source: SharpBrains - October 13, 2021 Category: Neuroscience Authors: Kaiser Health News Tags: Brain/ Mental Health Aduhelm Alzheimer’s Disease attention-problems brain bleeding brain swelling cognitive problems dementia dementia specialists early-stage Alzheimer’s Food and Drug Administration language problems memory pr Source Type: blogs