FDA, urged to avoid controversy, creates new headache with attack on UniQure
statnews.com • • business
Key Points:
- A senior FDA official anonymously criticized UniQure and its experimental gene therapy for Huntington’s disease during a Thursday media call, accusing the company of presenting "distorted" and "manipulated" clinical data for a "failed" treatment.
- The official, who expressed missing his clinical and teaching roles, highlighted internal FDA tensions and raised concerns about the agency's objectivity in regulating rare disease drugs.
- The FDA's public attack on UniQure risks political backlash amid the Trump administration's efforts to focus on popular health issues like drug pricing, especially as Congress pressures the agency to be more open to rare-disease therapies.
- This controversy follows previous FDA criticism, including the agency's handling of Moderna's flu vaccine application, which
