STAT+: Pharmalittle: White House imposes price limits for Regeneron Covid drug; lawmakers push federal agencies to prevent patent abuses

Top of the morning to you. And a fine one it is. Lots of sunshine and clear blue skies are once again enveloping the Pharmalot campus, where the official mascots are bounding about the grounds in search of creatures to annoy. As for us, we are as busy as ever hunting and gathering items of interest. We trust you have your own hectic agendas. So join us as we hoist the ever-present cup of stimulation — our choice today is roasted coconut — and attack the fast-growing to-do list. Have a grand day, everyone, and do stay in touch. …

A groundbreaking clause in a new deal between the U.S. Department of Health and Human Services and Regeneron Pharmaceuticals marks the first time the Biden administration has directly used its leverage to challenge list prices, STAT explains. The contract between the company and the government requires that the list price for a future monoclonal antibody drug to prevent Covid-19 is the same or lower in the U.S. as in other high-income countries. However, there is no indication which countries the government will be comparing prices with, or how pricing data will be determined.

Amid concerns over monopolies held by drugmakers, a bipartisan group of lawmakers introduced a bill that would require the companies to certify they have provided the same information to different federal government agencies when seeking marketing approval and patent protection, STAT reports. The goal is to ensure the U.S. Food and Drug Administration and the U.S. Patent and Trademark Office coordinate efforts to prevent pharmaceutical companies from unfairly extending monopolies on their medicines. The bill emerges two years after the Biden administration issued an executive order directing the agencies to work together to promote more competition and lower drug prices.

Continue to STAT+ to read the full story…