Tag Archives: US Food and Drug Administration

US FDA gang stokes kratom panic to grab more regulatory power, protect Big Pharma’s bottom line

Source: USA Today

“Citing 36 deaths, the Food and Drug Administration chief warned consumers Tuesday not to use the herbal supplement kratom to ease opioid withdrawal and announce plans to step its regulatory oversight to combat the opioid epidemic. The FDA public health advisory on kratom follows the Drug Enforcement Administration’s reversal or at least delay of plans to classify kratom as a controlled substance on the same level as heroin and LSD. FDA commissioner Scott Gottlieb says the FDA plans to work with the DEA to determine how kratom should be classified.” [editor’s note: To the best of my knowledge, the number of deaths actually attributed to kratom is zero and the 36 deaths mentioned were from other causes in people who happened to also used kratom. I’ve used it a few times myself for chronic back pain, with encouraging but uneven results – TLK] (11/14/17)

https://www.usatoday.com/story/news/politics/2017/11/14/fda-chief-warns-kratom-treat-opioid-addiction-seek-more-regulatory-power/860825001/

US FDA approves first digital ingestion tracking system med

Source: US News & World Report

“The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system, in an unprecedented move to ensure that patients with mental illness take the medicine prescribed for them. The drug Abilify MyCite was developed by Otsuka Pharmaceutical Co., Ltd. The drug Abilify was first approved by the FDA in 2002 to treat schizophrenia, and the ingestible sensor, made by Proteus Digital health, was approved for marketing in 2012. The FDA said in a statement Monday that the digitally enhanced medication ‘works by sending a message from the pill’s sensor to a wearable patch.'” (11/14/17)

https://www.usnews.com/news/business/articles/2017-11-14/govt-approves-first-ever-med-with-digital-tracking-system

ACLU sues FDA over abortion pill restrictions

Source: The Hill

“The American Civil Liberties Union (ACLU) filed a lawsuit Tuesday against the Food and Drug Administration (FDA), challenging federal restrictions they argue ‘significantly’ limit access to abortion pills. Currently, a prescription for the abortion pill Mifeprex cannot be filled at a retail pharmacy. Instead, the pill must be obtained from a clinic, medical office or hospital from a health-care provider that has pre-registered with the drug manufacturer. … The ACLU says the rules violate the 2016 Supreme Court decision Whole Woman’s Health v. Hellerstedt, which ruled that health regulations must serve patient health and cannot burden access to abortion without a valid medical justification.” (10/03/17)

http://thehill.com/policy/healthcare/353690-aclu-sues-fda-over-abortion-pill-restrictions

FDA rebukes bakery for claiming “love” as an ingredient in granola

Source: Philadelphia Inquirer

“The ingredient list for Massachusetts-based Nashoba Brook Bakery’s granola was normal enough, save for one ingredient. Amid the oats and sweetener was ‘love.’ The subject of nearly every rock-and-roll song, the thing Romeo and Juliet died for, was supposedly in the granola, which was sold at around 120 stores around New England. … ‘I really like that we list ‘love’ in the granola,’ Nashoba Chief Executive Officer John Gates told Bloomberg News. ‘People ask us what makes it so good. It’s kind of nice that this artisan bakery can say there’s love in it and it puts a smile on people’s face.’ But the Food and Drug Administration didn’t see it that way. A human emotion, it said, cannot be an ingredient in baked goods. The FDA published a warning letter to the bakery on Tuesday, which told the bakery to stop claiming that its granola contains love …” (10/04/17)

http://www.philly.com/philly/business/fda-rebukes-bakery-for-claiming-love-as-an-ingredient-in-granola-20171004.html

FDA approves the first gene therapy for cancer

Source: MIT Technology Review

“A revolutionary cancer therapy that uses genetically engineered immune cells has been approved by the U.S. Food and Drug Administration, ushering in a new era of cancer treatment. The FDA calls the treatment, marketed by Novartis, the ‘first gene therapy’ to be available in the U.S. The therapy is designed to treat an often-lethal type of blood and bone marrow cancer that affects children and young adults. Known as a CAR-T therapy, the approach has shown remarkable results in patients. The one-time treatment will cost $475,000 but Novartis says there will be no charge if a patient doesn’t respond to the therapy within a month.” (08/30/17)

https://www.technologyreview.com/s/608771/the-fda-has-approved-the-first-gene-therapy-for-cancer/

Bucking FDA, frequently arch-statist Thiel funds offshore herpes vaccine trial

Source: Ars Technica

“Heavyweight tech investor and FDA-critic Peter Thiel is among conservative funders and American researchers backing an offshore herpes vaccine trial that blatantly flouts US safety regulations, according to a Monday report by Kaiser Health News. The vaccine — a live but weakened herpes virus — was first tested in a 17-person trial on the Caribbean Island of St. Kitts without federal oversight or the standard human safety requirement of an institutional review board (IRB) approval. Biomedical researchers and experts have sharply rebuked the lack of safety oversight and slammed the poor quality of the data collected, which has been rejected from scientific publication. However, investors and those running the trial say it is a direct challenge to what they see as innovation-stifling regulations by the Food and Drug Administration.” [editor’s note: Why would a drug trial in a foreign country require “federal oversight?” – TLK] (08/28/17)

https://arstechnica.com/science/2017/08/bucking-fda-peter-thiel-funds-patently-unethical-herpes-vaccine-trial/

FDA cracks down on patients who don’t think they should need FDA’s permission to get treatment

Source: Los Angeles Times

“The Food and Drug Administration has launched an opening salvo at a booming national market for suspect medical treatments, announcing actions that could rein in clinics offering questionable stem-cell treatments for cancer and other diseases. The FDA’s initial targets were a pair of California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage; StemImmune Inc. of San Diego; and the US Stem Cell Clinic of Sunrise, Fla. Taking what it called ‘decisive action’ to protect patients [sic], the FDA on Friday dispatched U.S. marshals to the California clinics and seized close to 500 doses of smallpox vaccine supplied by StemImmune.” (08/28/17)

http://www.latimes.com/science/sciencenow/la-sci-sn-fda-stem-cells-20170828-story.html

The FDA warms to vaping

Source: Reason
by Jacob Sullum

“On the face of it, the decision that the Food and Drug Administration (FDA) announced on Friday, extending by four years a crucial deadline for e-cigarette manufacturers to seek approval of their products, was no more than a stay of execution. But the FDA also signaled a new receptiveness to vaping as a harm-reducing alternative to smoking, which suggests this reprieve could turn into a commutation. That would be good news for smokers who want to quit and for anyone sincerely interested in helping them. For too long American public health officials have been unreasonably hostile to e-cigarettes, which are far less hazardous than the conventional kind and offer a closer simulation of the real thing than nicotine gum or patches do.” (08/02/17)

http://reason.com/archives/2017/08/02/the-fda-warms-to-vaping

FDA’s new vision for tobacco harm reduction

Source: Heartland Institute
by Brad Rodu

“U.S. Food and Drug Administration Commissioner Scott Gottlieb on July 28 fully endorsed tobacco harm reduction. In a speech (here), he clearly defined the problem: ‘[I]t’s cigarettes that are the primary cause of tobacco-related disease and death.’ Dr. Gottlieb cited facts about nicotine, emphasizing its addictive qualities and the need to keep children away from all tobacco products. He also made one critical distinction: ‘[T]he nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year. Yes, it got them all addicted and kept them addicted for the long term. And it got most of them addicted when they were still teenagers. But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine.’ This has been one of my principle themes for over two decades.” (08/01/17)

http://blog.heartland.org/2017/08/fdas-new-vision-for-tobacco-harm-reduction/

FDA looks to move smokers toward e-cigarettes

Source: NBC News

“The U.S. Food and Drug Administration aims to reduce nicotine levels in cigarettes while exploring measures to move smokers toward e-cigarettes, in a major regulatory shift announced on Friday that sent traditional cigarette company stocks plunging. The move means FDA Commissioner Scott Gottlieb has thrown his regulatory weight on the side of those advocating for e-cigarettes in the debate over whether they potentially hold some public health benefits. Shares of major tobacco companies in the United States and UK slumped in heavy trading volume, with the world’s biggest producers poised to lose about $60 billion of market value.” (07/28/17)

http://www.nbcnews.com/health/health-news/fda-looking-move-smokers-toward-e-cigarettes-n787491