Testimony at FDA on Eteplirsen for Duchenne Muscular Dystrophy

April 25, 2016. U.S. law requires evidence of safety and effectiveness. The burden of proof lies with Sarepta. If this drug actually works, then Sarepta has failed itself, the patients, and their families, by not conducting a better study that could provide convincing evidence showing that it works.

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Letter to House Appropriation Committee Members Regarding FDA’s Proposed Rule on the Labeling of Generic Drugs

April 18, 2016. The National Center for Health Research strongly urges you to remove the anti-consumer language from the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for fiscal year 2017. The language (Section 747) was added at the 11th hour and it would prevent the FDA from finalizing its proposed rule on generic drugs labeling.

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