Morning Briefing
Summaries of health policy coverage from major news organizations
White House Shines Spotlight On GOP Plans Against Medicare, Social Security
The Biden administration is already building on a strategy it deployed during the midterm election season in which it highlighted talk from multiple GOP congressional lawmakers about how they plan to use their new House majority to consider cuts to entitlement programs like Social Security and Medicare. (Gangitano and Samuels, 1/10)
In other political, legal news 鈥
The Food and Drug Administration鈥檚 approach to evaluating some new medical devices might actually increase the risk that those devices will later be recalled over safety concerns. For some medical devices, the FDA requires data from studies in people to show that the device, including things like implantable heart defibrillators or stents, is safe and effective. That process is roughly equivalent to how regulators review new medicines. But the FDA also approves devices including artificial joints, infusion pumps, and scalpels using a process known as the 510(k) pathway, which simply lets manufacturers show that the new devices are 鈥渟ubstantially equivalent鈥 to products already on the market.聽(Herper, 1/10)
Sun Pharmaceutical, one of the world鈥檚 largest generic drugmakers, was scolded by the U.S. Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. (Silverman, 1/10)
The U.S. Food and Drug Administration on Monday said it has issued warning letters to manufacturers of medical scopes used in surgical procedures, citing violations found during inspections of facilities in Japan. Warning letters pertain to a category of devices known as endoscopes, which allow doctors to see and access the urinary tract, gastrointestinal tract, and respiratory tract, during diagnostic and therapeutic procedures. (1/10)
鈥淭his is a great shot in the arm,鈥 Regan told reporters Tuesday afternoon. "We all know communities know their problems better than the federal government does. 鈥 We know we are going to see different types of grants from all over the country." The agency will offer the grants in two categories. The first will provide $30 million directly to community-based nonprofits through its Environmental Justice Collaborative Problem-Solving Program. (Brugger, 1/10)