Morning Briefing
Summaries of health policy coverage from major news organizations
Under Pressure To Reduce Red Tape, FDA To Hold Hearing On Approval Process
Modern Healthcare: FDA To Host Hearing On Assessing Risks, Benefits In New Drugs
The Food and Drug Administration this week is holding a public hearing on how risk assessments are conducted on new drugs. The agency is under immense pressure to reduce review and approval times of drugs in order to lower costs but also ensure medications are safe before they go to market. In 2014, the FDA implemented a more structured approach to how new drugs are approved based on their safety risks, the severity of the disease and the availability of other drugs to treat that disease. The effort was part of the reauthorization of the Prescription Drug User Fee Act in 2010. At this week's meeting, the FDA will likely hear testimony on experiences with this approach and ways to better incorporate the patient perspective into the process. (Castellucci, 9/16)
In other pharmaceutical news —
Bloomberg: Walgreens Said To Tweak Rite Aid Deal To Clinch U.S. Approval
Walgreens Boots Alliance Inc. is poised to revise its agreement to buy individual Rite Aid Corp. stores, a move that may be enough to resolve outstanding antitrust concerns and clinch U.S. approval for a deal the companies have been pursuing in different forms for two years, said people familiar with the matter. Walgreens is in the final stage of negotiations with the Federal Trade Commission about its plan to buy more than 2,000 Rite Aid stores and is set to propose a modified deal that could be announced as soon as Monday, according to three people, who declined to be identified because the talks are confidential. (McLaughlin and Langreth, 9/18)
California Healthline: California Drug Price Bill Sweeping In Scope, Lacking In Muscle
A California bill headed to the governor’s desk may be the most sweeping effort in the nation to shine a light on drug pricing, but it lacks the muscle being applied in other states to directly hold those prices down. The idea behind the law is that if everyone knows when and why prices are rising, political leaders eventually will be more empowered to challenge those increases. (Bartolone, 9/18)
