The government seeks make it easier for cancer patients to use experimental drugs; a federal judge says the FDA can regulate stem cell companies; US senators reveal a list of 400 troubled nursing homes.
The FDA seeks to facilitate the process for granting cancer patients “compassionate use” access to experimental drugs which have shown promising results in studies but aren’t currently available to the public, according to The New York Times. Yesterday, at the 2019 American Society of Clinical Oncology’s Annual Meeting in Chicago, the FDA announced a project to have the agency serve as a middleman. This would allow physicians to avoid having to first plead their case to companies, then to the agency if the company agrees to provide the drug. Instead, contacting the FDA would become the initial step, then the agency would assign a staffer to quickly complete required paperwork.
US District Court Judge Ursula Ungaro ruled in favor of the FDA yesterday in a lawsuit against US Stem Cell, a Florida-based, for-profit company whose treatments previously blinded 4 patients, The Washington Post reported. Ungaro agreed the FDA has the authority to regulate a widespread procedure that uses fat from patients to create a stem cell treatment and ruled the FDA is entitled to an injunction ordering the company to stop the procedures. The ruling represents a victory for the government, which has struggled to constrain the growing industry.
US senators Bob Casey, D-Pennsylvania, and Pat Toomey, R-Pennsylvania, released a list, provided to them by CMS, of nursing homes with a “persistent record of poor care” whose names weren’t previously disclosed to the public by the government, The New York Times reported. The list identified almost 400 facilities across the nation with documented problems that weren’t included on a shorter list of nursing homes that faced increased federal scrutiny and had warning labels. According to the senators, the secrecy undermines the federal commitment to ensure transparency for families seeking facilities for their family members and raises questions about why the names of some problematic homes were disclosed while others weren’t.