Members of Congress ask the FDA for documents relating to Aduhelm's controversial approval; outside experts will advise the FDA on booster shots; nursing shortages intensify.
Members of Congress have requested documents from the FDA related to its controversial approval of Biogen’s Alzheimer disease drug Aduhelm, STAT reported. The 2 panels, who had previously requested documents from Biogen, sent the request to acting FDA Commissioner Janet Woodcock, MD, marking the first public request by Congressional investigators to the agency. The requests come as previous reporting revealed Biogen had an off-the-books meeting with an FDA official prior to Aduhelm’s approval. The data requested touches on several of the drug’s controversies, including information as to why Aduhelm’s original indication was broader than populations studied in clinical trials.
On September 17, a group of outside advisors will meet with the FDA to discuss the need, or lack thereof, for COVID-19 booster shots, The Washington Post reported. The meeting is slated to take place 3 days prior to the original date the agency said Americans will become eligible to receive the booster shots. The meeting will be public and is expected to grant more clarity to the recommendations, which have been seen as unnecessary by some. It will also focus on data provided by Pfizer/BioNTech, although the panel’s recommendations are not binding. Some have criticized the United States’ decision to administer boosters to its own population while much of the world’s population has yet to receive an initial vaccine. Israel has already started administering boosters to its population.
Hospitals throughout the United States have been hit with acute nursing shortages as many leave the profession due to burnout, or turn to more lucrative opportunities with traveling agencies, according to the Associated Press. Although not a new problem wrought by the pandemic, the shortages have now lead to a crisis where some hospitals, strapped for cash, are unable to pay to get the help they need to treat COVID-19 patients. Mounting frustration among nurses tasked with treating unvaccinated patients and being harassed by members of their communities also contributes to the shortage.