FDA Head Unsurprised By Aduhelm Approval Investigation
The controversial fast-track FDA approval of Alzheimer's drug Aduhelm prompted a congressional investigation, and now FDA commissioner Robert Califf is said to not disagree with its findings. Meanwhile, the Wall Street Journal says the FDA is increasingly halting experimental human trials.
Stat:
FDA Head Califf: Aduhelm Approval Investigation Held "No Surprises"
U.S. Food and Drug Administration commissioner Robert Califf doesn’t disagree with the basic findings of a congressional investigation into the agency’s role in the controversial approval of Aduhelm, Biogen’s first Alzheimer’s drug. He just wishes the report’s tone had been different. (Wosen, 1/9)
The Wall Street Journal:
FDA Increasingly Halting Human Trials As Companies Pursue Risky, Cutting-Edge Drugs
The Food and Drug Administration is pressing pause on drug-company testing of experimental medicines more often, a side effect of the industry’s move into promising but less-proven technologies. (Essley Whyte, 1/10)
On other legal, health news —
Reuters:
U.S. Supreme Court Rebuffs Pfizer Plan To Help Patients Pay For Heart Medication
The U.S. Supreme Court on Monday turned away Pfizer Inc's (PFE.N) bid to revive its plan to cover out-of-pocket expenses of Medicare patients for drugs costing $225,000 a year to treat a rare heart condition after federal officials found that the drugmaker's arrangement could amount to illegal kickbacks. (Chung, 1/9)
Reuters:
U.S. Appeals Court Won't Revive Zofran Birth Defect Cases Against GSK
A federal appeals court on Monday declined to revive hundreds of lawsuits by women who claim that GlaxoSmithKline Plc failed to warn them that taking the anti-nausea drug Zofran during pregnancy could cause birth defects. (Raymond, 1/10)
Meanwhile, concerning opioid settlements —
Reuters:
Teva Says Opioids Settlement To Move Forward In U.S.
Israeli drugmaker Teva Pharmaceutical Industries Ltd (TEVA.TA) said there was sufficient participation from U.S. states and local authorities to move forward with its nationwide settlement agreement to resolve opioid-related claims and litigation. (1/9)
