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Lessons Still Not Learned from the Infant Formula Crisis
Gabriella Beaumont-SmithOn March 28, the House Oversight Committee heldpart one of hearings on the Food and Drug Administration (FDA) and its handling of the infant formula crisis. Former FDA Deputy Commissioner Frank Yiannas testified that the crisis could have been averted, or at the very least, the magnitude lessened. At Cato, we completelyagree.Unfortunately, Yiannas ’ proposed solution was more of what got us into this mess in the first place: overregulation of the formula industry and overbearing FDA authority. Other policymakers argue for much the same.Yet the infant formula industry ’s weakness is not owed to a...
Source: Cato-at-liberty - April 6, 2023 Category: American Health Authors: Gabriella Beaumont-Smith Source Type: blogs

The 510(K) Third Party Review Program: Promise and Potential
Brian Miller (Johns Hopkins University), William Blanks (West Virginia University), Brian Yagi (Johns Hopkins University), The 510(K) Third Party Review Program: Promise and Potential (2023): Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - March 27, 2023 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

DRAFT: Enough Excuses on Drug Importation a New Transnational Paradigm for FDA Regulation and Lower U.S Drug Prices
Gabriel Levitt (Brooklyn Law School), DRAFT: Enough Excuses on Drug Importation a New Transnational Paradigm for FDA Regulation and Lower U.S Drug Prices, 49 Brooklyn J. Int ’l L. 1 (2023): The U.S. Food and Drug Administration (“FDA”), which enforces drug... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - March 22, 2023 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

Propelling Rare Disease Research for More Than 50 Years
Vials of samples from the NIGMS HGCR. Credit: Coriell Institute for Medical Research. The year 2022 marked 50 years since the creation of the NIGMS Human Genetic Cell Repository (HGCR) at the Coriell Institute for Medical Research in Camden, New Jersey. The NIGMS HGCR consists of cell lines and DNA samples with a focus on those from people with rare, heritable diseases. “Many rare diseases now have treatments because of the samples in the NIGMS HGCR,” says Nahid Turan, Ph.D., Coriell’s chief biobanking officer and co-principal investigator of the NIGMS HGCR. She gives the example of a rare disease advocacy group wh...
Source: Biomedical Beat Blog - National Institute of General Medical Sciences - February 22, 2023 Category: Research Authors: Chrissa Chverchko Tags: Cells Genes Injury and Illness Diseases Genomics Scientific Process Source Type: blogs

Tuned Receives $3.5 Million in Funding to Shape the Future of Hearing Wellness
With a dedicated focus on hearing care, the funding will strengthen Tuned’s ability to bridge the gap between audiologists and the general public as a key employee benefit Tuned, a digital hearing health company focused on providing hearing care for all, today announced that it raised $3.5 million in funding led by Distributed Ventures with participation from Idealab NY and Elements Health Ventures. The funding will support Tuned’s mission to make comprehensive hearing care as affordable and accessible as possible while enabling the platform to be offered as a key employee benefit from 2023 onward. “This funding...
Source: EMR and HIPAA - February 21, 2023 Category: Information Technology Authors: Healthcare IT News Tags: Health IT Company Healthcare IT Affordable Care Affordable Healthcare Audiology Danny Aronson Digital Health Digital Hearing Health Distributed Ventures Elements Health Ventures FDA Food and Drug Administration Health IT Funding Source Type: blogs

Mark Cuban Cost Plus Drug Company ( " MCCPDC " ) PBC May Be Able to Say " Mission Accomplished " Even if Sales Stop Growing
On January 19, 2022, a startup called theMark Cuban Cost Plus Drug Company ( " MCCPDC " )opened its doors to the American public as a new online pharmacy and generic manufacturing startup. Initially, MCCPDC was also planning to launch its own Pharmacy Benefit Manager, but it later scrapped those plans, instead announcing several PBM partnerships with some PBM startups which do not engage in " spread pricing " , including on generic, biosimilar and " authorized generic " drugs. The company bears the name of its famous principal investor, multibillionaire Mark Cuban, who is perhaps best known as both owner of the NBA te...
Source: Scott's Web Log - February 7, 2023 Category: Endocrinology Tags: authorized generic 2023 Alex Oshmyansky authorized generics Biosimilar biosimilars Cost Plus costplus drug company drug prices drug pricing generic drugs mark cuban Mark Cuban Cost Plus Drug Company Source Type: blogs

Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform
Matthew Herder (Dalhousie University), Aducanumab, Accelerated Approvals& the Agency: Why the FDA Needs Structural Reform, J. L. Med.& Ethics (Forthcoming): The US Food and Drug Administration ’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - February 5, 2023 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

Practicing Medicine without a License: When Patients and Politicians Play Doctor
BY MICHAEL KIRSCH We’ve all heard the adage, leave it to the professionals. It’s typically used when an individual has wandered out of his lane. How many folks go beyond their knowledge and skills with home projects, for example, who must then hire a real professional to mop up the mistakes? Luckily for me, the only tools that I – a gastroenterologist – know how to use are a colonoscope and an endoscope, so there’s no chance that I will be tempted to perform any plumbing or electrical tasks at home. Although patients are not medical professionals, they routinely bring me results...
Source: The Health Care Blog - February 1, 2023 Category: Consumer Health News Authors: Ryan Bose-Roy Tags: Health Policy Medical Marijuana Medical Practice medical professionals michael kirsch politicians Source Type: blogs

Fentanyl Test Strips Save Lives, Yet Most States Ban Them As “Drug Paraphernalia”
Jeffrey A. SingerToday ’s Wall Street Journalreports that recreational drug users at parties and nightclubs increasingly use fentanyl test strips before engaging in drug use. Singer ‐songwriter Kalie Shorr, who has lost a sister and childhood friend to drug overdoses, keeps them with her in her purse and offers them to partiers and nightclub goers:Just dissolve the cocaine in a small amount of water, she tells them. Then dip in the test strip, and wait a few minutes to see if one line (positive) or two lines (negative) appear. “You can put it up your nose if you feel so inclined,” she said. “But...
Source: Cato-at-liberty - January 19, 2023 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

A Proposal to Accelerate Progress Towards Human Rejuvenation
Here find the first draft of a proposal regarding the best way forward at the present time to accelerate progress towards the development of diverse, effective rejuvenation therapies. The key is to use philanthropic funding to (a) prove efficacy in low-cost clinical trials, and then (b) market that data to ensure physician adoption of the first working rejuvenation therapies. A PDF version of this draft also exists. Executive Summary 1. Aging is by far the greatest cause of human morbidity and mortality. 2. Rejuvenation therapies that will greatly reduce unnecessary late life suffering and death ar...
Source: Fight Aging! - January 13, 2023 Category: Research Authors: Reason Tags: Activism, Advocacy and Education Source Type: blogs

New option for H pylori treatment: Voquezna
The Food and Drug Administration (FDA) has approved the following new medication for the treatment of Helicobacter pylori (H. pylori) infection in adults.:- Voquezna Triple Pak(vonoprazan, amoxicillin, clarithromycin)-Voquezna Dual Pak (vonoprazan, amoxicillin)Vonoprazan, which gives the name of the medication, is an oral small molecule potassium-competitive acid blocker.H. pylori eradication rates were84.7% and 78.5% with Voquezna Triple and Dual Pak, respectively.Voquezna Triple Pak is supplied as a carton containing 56-tablets and 56-capsules divided into 14 daily dose blister cards. Each daily blister card contai...
Source: Clinical Cases and Images - Blog - January 13, 2023 Category: Universities & Medical Training Tags: Infectious Diseases Source Type: blogs

Big Dairy Milks Congress for Baby Formula Tariffs
Gabriella Beaumont-SmithJanuary 11th isNational Milk Day and this year, the U.S. dairy industry has a lot to celebrate.While the 2022 baby formula crisis grappled the United States, the National Milk Producers Federation called on Congress toresistnew action. In November, the groupurged Congress to oppose any efforts to extend the tariff suspensions emergently granted to baby formula imports amidst the crisis. Unsurprisingly, Big Dairy succeeded —on January 1st, thetariffs returned on imports of infant formula meaning these imports are again subject to an effective tax of about 25 percent.To recap, the baby formula cri...
Source: Cato-at-liberty - January 11, 2023 Category: American Health Authors: Gabriella Beaumont-Smith Source Type: blogs

If SAMHSA Seriously Wants to Destigmatize People with Substance Use Disorder, It Can Start by Destigmatizing How They Receive Treatment
Jeffrey A. SingerIn 2001, the Food and Drug Administration transferred regulation of methadone treatment programs for opioid use disorder (nowadays called Opioid Treatment Programs or OTPs) to the Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration. DEA and SAMHSA work together to establish and enforce criteria for treating people with substance use disorder and the regulations that govern how health care practitioners prescribe and administer opioids as medication assisted treatment (MAT) for opioid use disorder. The rules govern the dose and number of drugs clinicians prescri...
Source: Cato-at-liberty - January 3, 2023 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)
FDA acknowledges shortcomings of Pre-Cert pilot in report (Regulatory Focus): The US Food and Drug Administration (FDA) said it needs additional Congressional authority to move forward with its digital health precertification (Pre-Cert) program. While the idea has been widely lauded by various stakeholders, at least one expert said he feels vindicated for warning the agency early on that it lacked the legal authority to fully implement pathway. In 2017, the FDA proposed the idea of a Pre-Cert program that would act as a new pathway for software as a medical device (SaMD) products, through which the agency could green-light...
Source: SharpBrains - December 20, 2022 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Technology & Innovation digital health FDA Pre-Cert precertification software as a medical device US Food and Drug Administration Source Type: blogs

Fecal Microbiota Transplant Treatment Approved by the FDA
The balance of microbial populations making up the gut microbiome changes with age in ways that produce harm, such as loss of beneficial metabolites, and generation of chronic inflammation. This form of aging is only loosely connected to age-related damage in our tissues, in that animal studies appear to show that a readjustment of the balance of populations in the gut microbiome of an aged animal, making it more youthful, will persist even as aging progresses in the body. In killifish, the result is improved health and extended life span; in mice, similar studies have demonstrated improved health, with lifespan studies ye...
Source: Fight Aging! - December 13, 2022 Category: Research Authors: Reason Tags: Politics and Legislation Source Type: blogs