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.

Insulin Federalism
Jordan Paradise (Loyola University Chicago), Insulin Federalism, 27 B.U. J. Sci.& Tech. (2021): In April 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb decreed interchangeable insulin poised for market entry within the next few years. This makes... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - October 5, 2021 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

A Popular Science Article on Young Blood versus Old Blood in the Development of Treatments for Aging
The popular science article I'll point out today does a fair job of following the past decade or so of work arising from heterochronic parabiosis, in which the circulatory systems of a young animal and an old animal are joined. The young animal exhibits some degree of accelerated aging, while the old animal exhibits some degree of rejuvenated function. The question all along has been why exactly this happens: what are the underlying mechanisms, and can they be replicated as a basis for therapy. The obvious first approach was to transfuse young donor blood into old recipients, as positive results would mean that the ...
Source: Fight Aging! - October 4, 2021 Category: Research Authors: Reason Tags: Medicine, Biotech, Research Source Type: blogs

Time to Stand Up For The Morality of Vaccine Mandates
Arthur Caplan, PhD ABPD Statement in Support of COVID-19 Vaccine Mandates For All Eligible Americans The Association of Bioethics Program Directors (ABPD) represents the leadership of nearly 100 academic bioethics programs at medical centers and universities across North America. In the face of the ongoing worldwide COVID-19 pandemic, vaccines have been medically shown to greatly reduce rates of COVID-19 infection, transmission, severe disease, and death. With full approval by the U.S. Food and Drug Administration of one COVID-19 vaccine and others soon to follow, the clear benefits of vaccination when com...
Source: blog.bioethics.net - October 4, 2021 Category: Medical Ethics Authors: Arthur Caplan Tags: Featured Posts Professionalism Public Health Vaccines Source Type: blogs

FDA Panel Wants to Deny Adults the Right to Decide How Much COVID Protection They Want
Jeffrey A. SingerThe Food and Drug Administration ’s scientific advisory panel recommendedagainst approving Pfizer/ BioNTech booster vaccinations for the general population aged 16 and above. The boosters are currently only approved for immunocompromised individuals and patients in nursing homes—patients who are more vulnerable than the general population to get breakthrough infections that result in hospita lization or death.Concluding that the vaccines offer the general adult population robust protection against severe disease that can possibly result in hospitalization or death, the committee decided the protecti...
Source: Cato-at-liberty - September 17, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Roger Chou ’s Undisclosed Conflicts of Interest: How the CDC’s 2016 Guideline for Prescribing Opioids for Chronic Pain Lost Its Clinical and Professional Integrity
by Chad D. Kollas MD, Terri A. Lewis PhD, Beverly Schechtman and Carrie Judy“I ' m present. Uh … I do have a conflict. I receive funding to conduct reviews on opioids, and I ' ll be recusing myself after the um, director ' s, uh, um, um, uh … update.”- Dr. Roger Chou, Center for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) Meeting Friday, July 16, 2021.IntroductionFor those familiar with the controversial relationship between the anti-opioid advocacy group, Physicians for Responsible Opioid Prescribing (PROP, recently renamed, He...
Source: Pallimed: A Hospice and Palliative Medicine Blog - September 17, 2021 Category: Palliative Care Tags: CDC judy kollas lewis opioid pain schechtman Source Type: blogs

Roger Chou �s Undisclosed Conflicts of Interest: How the CDC�s 2016 Guideline for Prescribing Opioids for Chronic Pain Lost Its Clinical and Professional Integrity
by Chad D. Kollas MD, Terri A. Lewis PhD, Beverly Schechtman and Carrie Judy�I ' m present. Uh � I do have a conflict. I receive funding to conduct reviews on opioids, and I ' ll be recusing myself after the um, director ' s, uh, um, um, uh � update.�- Dr. Roger Chou, Center for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) Meeting Friday, July 16, 2021.IntroductionFor those familiar with the controversial relationship between the anti-opioid advocacy group, Physicians for Responsible Opioid Prescribing (PROP, recently renamed, Health Pro...
Source: Pallimed: A Hospice and Palliative Medicine Blog - September 17, 2021 Category: Palliative Care Tags: CDC judy kollas lewis opioid pain schechtman Source Type: blogs

Eight Reasons For Ending Joe Biden ’s Travel Bans
Ryan Bourne and Brad SubramaniamBack in July, Ioutlined why Joe Biden ’s crude COVID-19 travel bans on non-Americans coming from Europe, India, and a few other countries no longer made any sense from a public health perspective.Talk in Washington at the time was of lifting these restrictions by September. Well, here we are, mid-way through that month and the restrictions are going strong. Officials and diplomats now seem to think October or even Thanksgiving are the earliest potential dates for their removal. Some ponder whether the political incentives might point towards inactionuntil the mid-terms...which would mean b...
Source: Cato-at-liberty - September 16, 2021 Category: American Health Authors: Ryan Bourne, Brad Subramaniam Source Type: blogs

The FDA ’s Inexplicable Crusade Against Tobacco Smoking Harm Reduction Continues
Jeffrey A. SingerWhile the press was understandably preoccupied with the White Housecommandeering private businesses to enforce a COVID vaccine mandate on September 9, it gave little attention to the Food and Drug Administration ’s strike against an effective form of tobacco harm reduction on the same day. The FDA was under a court order to review 6.5 million applications from over 500 companies to market nicotine ‐containing e‐cigarettes andrejected 90 percent of them, while itdelayed deciding on applications from Juul, which commands an overwhelming share of the vaping market. One can be forgiven fo...
Source: Cato-at-liberty - September 13, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Biden Proposes Government Price Controls on Prescription Drugs
Michael F. CannonPresident Biden ’s Department of Health and Human Services hasissued a report proposing to reduce the prices government pays for prescription drugs (good) and proposing government price controls on private drug purchases (bad).The optimal price government should pay for medical care, including prescription drugs, is $0.00. Lowering the prices government pays for drugs reduces government spending and the burden that Medicare and other government programs impose on taxpayers. Everyone who supports smaller government (read: Republicans) should support reducing the prices Medicare pays for prescription ...
Source: Cato-at-liberty - September 9, 2021 Category: American Health Authors: Michael F. Cannon Source Type: blogs

FDA Finally Grants Full Approval to Pfizer Vaccine
Jeffrey A. SingerAftercalls from members of the scientific, public health, and medical community —myself included —the Food and Drug Administration finally overcame bureaucratic inertia and granted full approval to the Pfizer‐BioNTech mRNA COVID-19 vaccine—ahead of its self‐imposed deadline of January 2022. This is good news. Pfizer will now market the vaccine under the brand nameComirnaty.Hundreds of millions of doses have been administered over the course of nearly a year and the safety profiles of these vaccines have been remarkably good. Now the FDA should move quickly on the other mRNA vaccin...
Source: Cato-at-liberty - August 23, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Two Cheers for Full FDA Approval of the Pfizer ‐BioNTech COVID-19 Vaccine
Michael F. CannonThe right to make one ’s medical decisions isa fundamental human right. Taking health care rights seriously means recognizing that consumers have a right to choose which medical products they use and that government has no right to stand in their way.From the moment Ugur Sahin and his colleaguesdeveloped the Pfizer ‐BioNTech COVID-19 vaccine in January 2020, they and consumers have had the right to sell and buy it, so long as both parties agreed to the transaction. When government interferes with that right to voluntary exchange, it interferes with the rights of patients to make their own ...
Source: Cato-at-liberty - August 23, 2021 Category: American Health Authors: Michael F. Cannon Source Type: blogs

If FDA Won ’t Rethink Rules on Off‐Label Drug Use, Courts Should
Walter OlsonAs Cato writershave longpointedout, the law takes a paradoxical stance toward so ‐called “off‐label” use of drugs approved for use by the Food and Drug Administration (FDA). On the one hand, it’s completely lawful for physicians to prescribe approved drugs for other than the FDA‐approved uses, and such uses are vital in everyday practice. Indeed, off‐la bel compounds oftenconstitute a “gold standard” of care in chemotherapy cancer treatments and other fields of medicine. On the other hand, the agency strictly prohibits makers of the compounds frompromoting such use, even when ...
Source: Cato-at-liberty - August 11, 2021 Category: American Health Authors: Walter Olson Source Type: blogs

Alzheimer ’s & Dementia researchers challenge FDA ’s approval of Aduhelm given lack of evidence for beta-amyloid as a marker
Doctors Blast Biogen Alzheimer Approval as ‘Regulatory Failure’ (Bloomberg): Top researchers who advised the U.S. Food and Drug Administration on Biogen Inc.’s Alzheimer’s drug blasted the agency for approving it, calling the decision a “regulatory failure” that is “at odds with the evidence.” The New England Journal of Medicine opinion piece, signed by seven members of an advisory panel that opposed clearing Biogen’s Aduhelm, is another sign of persistent furor over the agency’s decision … The new commentary is signed by them and four other panel members, including doctors from Harvard Medical School...
Source: SharpBrains - August 5, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Aduhelm Alzheimer's drug Alzheimers-treatment beta-amyloid Biogen cognitive FDA approval surrogate Source Type: blogs

Integrating music, movement and stroke rehabilitation, MedRhythms raises $25M to develop and commercialize digital therapeutic
MedRhythms raises 25m to get patients back in tune after a stroke (TechCrunch): MedRhythms secured $25 million in Series B funding to advance its digital therapy platform aimed at measuring and improving someone’s ability to walk after they have experienced a neurologic injury or disease … Company co-founder and CEO Brian Harris was a neurologic music fellow at Spaulding Rehabilitation Hospital in Boston, treating people with stroke and brain deficits with music. He began getting questions from patients and families on how they could access similar care outside of the hospital. Not seeing a suitable alternative, h...
Source: SharpBrains - August 2, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Technology & Innovation brain deficits breakthrough device chronic stroke walking deficits digital therapeutics digital therapy platform electrophysiological entrainment neural circuitry neurologic disorders neur Source Type: blogs

Anti ‐Vaxxers Turn to Big Government
Thomas A. FireyCOVID-19hospitalizations anddeaths are rising in the United States as the highly infectious Delta variant of the SARS-CoV-2 virus has becomethe dominant strain in the country. These serious cases arealmost entirely limited to people who are not vaccinated against the virus; for the vaccinated,infection rates are much lower and nearly all infections are no more troublesome than a cold or — at worst – a bout of the flu, and often go unnoticed altogether.COVID-19 causedat least11 percent of all U.S. deaths in 2020, making it thethird leading cause of death, behind only heart disease and cancer. So far in 20...
Source: Cato-at-liberty - August 2, 2021 Category: American Health Authors: Thomas A. Firey Source Type: blogs