FDA To Crack Down On Devices; Big Pharma Places Riskier Bets On Biologics
News reports cover developments in the pharmaceutical and medical device industries.
The Associated Press: "Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year. The Food and Drug Administration released recommendations Tuesday night designed to improve oversight of the U.S. device industry, including the government's ability to revoke approval for products that prove unsafe or ineffective" (Perrone, 8/3).
The Wall Street Journal: Meanwhile, "[r]ising pressure to find new products is prompting big pharmaceutical companies to license or acquire biotechnology companies' experimental medicines when they've barely been tested in human trials. Traditionally, the sector's big players preferred drugs with solid clinical evidence to show they work. But faced with the loss of patents on some big sellers, an overhaul of its own research-and development-priorities and demand for more innovative medicines, Big Pharma is gambling more of its deal dollars on riskier bets in an effort to replenish its pipeline with new technologies" (Douglas, 8/4).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.