The federal government needs to consider breaking up the powerful companies that have price-gouged patients and suppressed competition, a former top antitrust official for President Biden told STAT.

Jonathan Kanter — who left his job as DOJ assistant attorney general in December — said today’s biggest health care conglomerates have built platforms that let them extract heavy profits from consumers and taxpayers. That risks a situation where a few giants hold a “massive amount of power and control,” sidelining smaller doctors, pharmacists and insurers, he told STAT’s Bob Herman. 

Kanter declined to comment specifically on any company, including UnitedHealth Group, the largest health care company in America, or any pending DOJ lawsuits or investigations. DOJ is suing to block UnitedHealth’s acquisition of Amedisys, a home health and hospice company. Read Bob’s highlights from their conversation and watch the whole interview. 

Plus: The Justice Department is interviewing former UnitedHealth Group physicians about their experiences working at practices owned by the health care giant, two sources with knowledge of the inquiries told STAT’s Tara Bannow. At least one has also been approached by California’s AG office. Both doctors were interviewed for STAT’s Health Care’s Colossus series. 

from Politico:

PDURS PATTER — Noom, the weight-loss digital company that has urged policymakers to address the high price of brand-name GLP-1 drugs, unveiled a software update Monday that it says could be a model for the FDA to consider as pharmaceutical companies look to app add-ons to their labels to improve patient safety and outcomes.The update follows September 2023 draft guidance in which the FDA described how it plans to consider software applications that companies want to add to their drug labels to differentiate their products, known as prescription drug use-related software, or PDURS.Why it matters: Offering a clinically tested software option in tandem with a drug could improve patient adherence to medications both within and beyond the GLP-1 class, Noom CEO Geoff Cook said, which has well-known gastrointestinal side effects that drive some users to quit use — and regain weight. App updates include a meal planner and a side-effect tracker to help boost the behavioral change aspect of the drugs’ indicated use — diet and exercise.Getting software added to a drug label has historically meant firms would need to conduct a Phase III trial comparing the drug-software combination against medication use without the technological assistance. Cook said the PDURS framework would essentially allow companies to test the combo products in Phase IV studies when the drug is already on the market, making it less costly for firms to pursue clinical evidence supporting the use of their digital platforms.“We believe that there’s going to be kind of a gold rush toward these digital solutions — not just in GLP-1s … but that pair with a medication,” he told Lauren ahead of the announcement. “The fundamental thing here is that these pharma companies are going to be looking for different ways to distinguish themselves in a crowded market.”