FDA goes on offense amid surge of criticism for recent drug decisions
CNN • • business
Key Points:
- A senior anonymous FDA official publicly defended the agency’s decision to require an additional clinical trial for UniQure’s experimental gene therapy for Huntington’s disease, labeling it a “failed therapy” and criticizing outside scientists and former FDA veteran Dr. Janet Woodcock for their opposition.
- The FDA official disputed claims that the agency demands a placebo-controlled trial involving a lengthy sham brain surgery, clarifying that the placebo procedure requires under 30 minutes of anesthesia and minor scalp incisions, consistent with longstanding FDA policy for Huntington’s treatments.
- Dr. Janet Woodcock, who called the FDA’s decision “truly evil,” emphasized the need for the agency to review UniQure’s therapy and hold a public hearing, focusing on transparency and the review process rather
