FDA advisers recommend accelerated approval of a Sarepta gene therapy

Boston Globe, May 12, 2023: FDA advisers recommended accelerated approval of Sarepta gene therapy for Duchenne Muscular Dystrophy, despite questionable results and worrisome risks. We testified that lowering FDA standards harms all families, and that Duchenne patients deserve free access to affordable treatments until drugs are proven to work.

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FDA’s new plan to study opioids’ effectiveness faces resistance

STAT, April 19, 2023: An FDA proposal to study whether opioids are effective as a chronic pain treatment is facing major resistance from addiction and pain care experts who are not paid by industry. We told STAT that the proposed clinical trial is unethical because it will provide no new information and would make some patients more dependent on opioids.

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