Emails Reveal Depth Of FDA Officials’ Discontent Over Sarepta Approval
Comments in the emails posted on the Food and Drug Administration website underscore the level of concern some agency officials raised that proper procedures were not followed and key data was downplayed in the approval process for Sarepta's Duchenne muscular dystrophy drug.
FDA Emails Show How Upset Some Officials Were Over Sarepta Approval
Newly disclosed emails underscore the extent to which high-ranking US Food and Drug Administration officials were upset with the decision-making process used to approve a controversial Sarepta Therapeutics drug for combating Duchenne muscular dystrophy. The Sept. 14 emails were written in response to a memo that Dr. Robert Califf, the FDA commissioner had drafted in which he sided with Dr. Janet Woodcock, the controversial head of the drug review division. She had pushed hard to approve the Sarepta medication over objections of key people on her staff, one of whom had filed an official scientific dispute over the approval, which occurred on Sept. 19. (Silverman, 11/4)
In other news from the Food and Drug Administration —
Precision Fabrics Creates First Sheets To Prevent Bed Sores
Precision Fabrics partnered with Standard Textile, a global supplier of hospital linens with U.S. headquarters in Ohio, to test DermaTherapy. After 11 clinical trials at several hospitals showed incidences of pressure ulcers were reduced by 65 percent to 80 percent, the Food and Drug Administration in June certified DermaTherapy as a medical device. It's a first for a bed sheet, and it flips conventional thinking: Instead of sheets and pads protecting the mattress, they protect the patient. (Rife, 11/6)