FDA Sets New — And Unenforceable — Lead Level Guidance For Baby Food
Critics, however, say the move is too little, too late. Other FDA and pharma news is on AI-enabled medical devices, smaller PBMs, and more.
CNN:
FDA Sets New Lower Levels For Lead In Baby Food — Critics Say That’s Not Enough
For the first time in history, the US Food and Drug Administration has established guidance for levels of lead in processed baby foods that are sold on supermarket shelves and online. The agency’s action, announced Monday, only provides guidance to industry and is not enforceable. (LaMotte, 1/6)
Modern Healthcare:
FDA Issues Draft Guidance For AI-Enabled Medical Devices
The Food and Drug Administration is aiming to help developers of artificial intelligence-enabled medical devices understand the agency's mindset around the technology. The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of their AI-enabled medical device If finalized, it would be the first guidance from the FDA to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle. (Turner, 1/6)
Axios:
Late Rule To Lower Nicotine In Cigarettes Clears Hurdle
The Biden administration is a step closer to lowering the amount of nicotine in cigarettes after an 11th-hour proposal cleared a key White House review. The Food and Drug Administration rule, whose precise language hasn't been made public, offers the administration one more chance to address the harms of smoking after it punted on banning menthol in tobacco products. (Reed, 1/7)
In other pharmaceutical developments —
AP:
2 Indian Companies Charged With Smuggling Chemicals Used In Making Fentanyl
Two pharmaceutical companies based in India were charged Monday with smuggling chemicals used in the production of the deadly drug fentanyl, federal prosecutors in New York announced. Raxuter Chemicals and Athos Chemicals were charged in separate indictments with criminal conspiracy to distribute and import chemicals into the U.S., Mexico and elsewhere knowing they would be used to manufacture the synthetic opioid, according to U.S. District Attorney for the Eastern District of New York Breon Peace’s office. (1/6)
Stat:
ALS Drug From Calico, Anti-Aging Company, Fails In Study
In 2013, Google announced it would attempt to understand and ultimately slow aging through a company called Calico, a moonshot effort that would absorb at least $3.5 billion in funding, spawn rampant speculation, and generate dozens of academic papers but deliver few tangible results — until Monday. The first data have now emerged from a drug Calico developed. It failed. (Mast, 1/6)
Modern Healthcare:
Where Smaller PBMs Are Headed This Year
Although the pharmacy benefit manager market has long been controlled by three large, established players, many smaller PBMs are seeing a spike in interest. But the newer entrants will continue to face stiff competition this year as they seek more business. Smaller PBMs that advertise themselves as transparent have gained traction over the last few years as health insurers, employers and government entities look to deviate from the traditional spread pricing model. Many of these companies have said 2024 was their largest selling year, with an increasing number of large customers showing interest. (Berryman, 1/6)
