EPA To Stop Testing Chemical Toxicity On Animals By 2035
The agency is working to adopt testing methods that do not involve animals but that meet legal obligations for chemical safety. Plus: the FDA weighs Zyn's safer-than-cigarettes claim; the use of a device to treat ADHD is questioned; the role of llamas in drug development; and more.
The New York Times:
E.P.A. Promises a Ban on Animal Testing by 2035
The Environmental Protection Agency will stop using rabbits, mice, rats and other mammals to test the toxicity of chemicals by 2035, the agency said Thursday. Animal rights groups praised the move, while some environmental organizations said they worried that understanding the link between chemical exposure and cancer, or developmental or reproductive issues, would be harder to ascertain without animal testing. (Friedman, 1/22)
Updates from the FDA —
AP:
FDA Considers Whether Zyn Can Be Marketed As Safer Than Cigarettes
Americans who smoke may soon be hearing a lot more about Zyn, the flavored nicotine pouches that have generated billions in sales while going viral on social media. The Food and Drug Administration convened a public meeting Thursday to consider whether Philip Morris International should be allowed to advertise its pouches as a less-harmful alternative for adults who smoke cigarettes. Government documents and presentations made at the meeting suggest FDA regulators are leaning toward approving the company’s request. (Perrone, 1/22)
MedPage Today:
FDA Warns On CVS Gel After Serious Injuries Reported
The FDA warned on wound and burn care products from MediHoney and CVS after more than a dozen serious injuries were reported. "Integra LifeSciences identified packaging failures related to the MediHoney Wound and Burn products that could lead to a breach in the sterile barrier," the FDA said, adding that "use of product with a breached sterile barrier could lead to patient infection." Similarly, certain batches of CVS Wound Gel may also carry an infection risk. (Ingram, 1/22)
MedPage Today:
Study Questions Benefit Of FDA-Cleared Device For ADHD
A phase IIb trial in England suggested that a stimulation device cleared by the FDA in 2019 for children with attention-deficit/hyperactivity disorder (ADHD) may not be effective. (Monaco, 1/22)
Modern Healthcare:
FDA Clearances And Approvals: Boston Scientific, BD, Elekta
The Food and Drug Administration recently cleared and approved a variety of medical devices for clinical use, including a Boston Scientific catheter for use in atrial fibrillation treatment and Becton Dickinson’s breast biopsy system. Most of the devices received 510(k) clearance, meaning they are similar to other devices on the market and considered safe to use. One received premarket approval, meaning it is a highest-risk, or Class III, medical device that has been determined to be safe and effective. (Dubinsky, 1/22)
On prescription drugs —
ProPublica:
ProPublica Publishes Data On The Origins Of Generic Prescription Drugs
ProPublica on Friday published never-before-released data connecting generic drugs to the factories that manufactured them. The data powers Rx Inspector, our groundbreaking tool that allows you to find the factories where your generic drugs were made and their Food and Drug Administration inspection track records. The data, which ProPublica created by linking several FDA datasets, has never been made available by the agency before. It will allow anyone to connect prescriptions to the facilities they were manufactured in by linking National Drug Code numbers to FDA Establishment Identifiers of drug manufacturing facilities. (Roberts, 1/23)
NPR:
Can The Prescription Drug Leucovorin Treat Autism? History Says, Probably Not
At a press conference in late 2025, federal officials made some big claims about leucovorin, a prescription drug usually reserved for people on cancer chemotherapy. "We're going to change the label to make it available [to children with autism spectrum disorder]," said Dr. Marty Makary, commissioner of the Food and Drug Administration. "Hundreds of thousands of kids, in my opinion, will benefit." (Hamilton, 1/22)
Bloomberg:
Llamas Are Big Pharma’s Secret Weapon to Find New Drugs
Scientists have discovered the potential of the animals’ antibodies to thwart multiple diseases, and now drug developers are collectively plowing billions of dollars into a field that may yield a fresh generation of life-changing medicines. The targets include some hard-to-treat conditions like cancer, nerve pain and a chronic skin ailment. The llamas are a vital part of the experiment. In between dust baths and grazing, they get injections to trigger the production of their precious antibodies. The animals are some of the few to produce the tiny proteins, dubbed nanobodies, which scientists praise as easy to produce, manipulate and engineer. (Pham, 1/23)
