DEA Extends Pandemic-Era Telehealth Rules For Prescribing Drugs
Telehealth providers are pushing for permanent rules that allow certain controlled substances to be prescribed without an in-person medical appointment.
Modern Healthcare:
Providers Stress Need For Remote Prescribing Rules After DEA Extension
Telehealth groups expressed some relief at the Drug Enforcement Administration's extension of pandemic-era flexibilities allowing companies to continue prescribing certain controlled substances without in-person visits until the end of next year. They also pointed to the necessity of a permanent rule. The extension, published in the Federal Register Tuesday, authorizes providers to prescribe Schedule II-V controlled medications via telemedicine to new and existing patients, as they have since the COVID-19 pandemic began, through Dec. 31, 2024. (Turner, 10/10)
In updates from the FDA —
CNBC:
Supreme Court Won't Hear Challenge To FDA Rejection Of Flavored Vapes
The Supreme Court on Tuesday declined to hear arguments in a case challenging the Food and Drug Administration’s authority to reject approvals of flavored electronic cigarettes. The case is one of several challenges to the FDA’s regulation of the vaping industry, which has hooked members of a new generation on nicotine, and ballooned into an $8.2 billion market in less than a decade. (Constantino and Sykes, 10/10)
The New York Times:
Illicit Vapes And E-Cigarettes Flood Stores As F.D.A. Struggles To Combat Imports
Some vapes are appearing with increasing nicotine levels that approach those in a carton of cigarettes. U.S. regulators did not authorize them, but have failed to keep them off shelves. (Jewett, 10/10)
Reuters:
US FDA Warns Online Vendors To Stop Selling Unapproved Weight-Loss Drugs
The U.S. Food and Drug Administration (FDA) on Tuesday published letters warning two online vendors to stop selling unapproved versions of semaglutide and tirzepatide, the active ingredients in popular GLP-1 class medications including Novo Nordisk’s powerful weight-loss drug Wegovy. In the letters sent to Semaspace and Gorilla Healing on Oct. 2, the FDA said the only approved semaglutide products were Wegovy and Novo’s diabetes drugs Ozempic and Rybelsus. It noted that tirzepatide, the active ingredient in Eli Lilly’s Mounjaro, had only been approved for diabetes. (Wingrove, 10/10)
In other pharmaceutical developments —
Reuters:
Alnylam Gives Up On Expanded Use Of Heart-Disease Drug In US After FDA Declines Approval
Alnylam Pharmaceuticals said on Monday it would not pursue expanded use of its drug to treat a potentially fatal heart disease in the U.S. after the Food and Drug Administration declined to approve the medication despite a favorable recommendation from its advisers. (Sunny, 10/10)
Stat:
Liquid Biopsy For Lung Cancer Is Launched By Delfi
Delfi Diagnostics, a well-funded startup in the burgeoning field of creating blood tests to detect cancer, said on Monday that it is launching a new test, FirstLook Lung, to try to identify people who could most benefit from lung cancer screening. (Herper, 10/9)
Stat:
Akero's Treatment For NASH Falls Short In Cirrhosis Study
Akero Therapeutics said Tuesday that an experimental medicine failed to show a significant benefit for patients with cirrhosis caused by NASH, the most advanced and life-threatening stage of the fatty liver disease. (Feuerstein, 10/10)
CNBC:
As Covid-Testing Business Drops, Abbott Searches For New Line Of Business With Consumer Wearables
Abbott Laboratories CEO Robert Ford took the stage at the HLTH conference in Las Vegas on Tuesday to discuss the company’s expansion into a new market: consumer wearables. The health-care company offers a range of products but derives the bulk of its revenue from medical devices and diagnostic tools. Its 15-minute rapid Covid test was a boon for the company, bringing in a staggering $7.7 billion in sales in 2021 and $8.4 billion the following year, a sizable portion of its total 2022 sales of $43.7 billion. (Capoot, 10/10)
KFF Health News:
John Green Vs. Johnson & Johnson (Part 1)
Why is treating drug-resistant tuberculosis so expensive? Pharmaceutical giant Johnson & Johnson’s patents on a drug called bedaquiline have a lot to do with it. In this episode of “An Arm and a Leg,” host Dan Weissmann speaks with writer and YouTube star John Green about how he mobilized his massive online community of “nerdfighters” to change the company’s policy and help make the drug more accessible. (10/11)
