May 24, 2016. NCHR agrees with many of the recommendations in the guidance and strongly urge the FDA to consider our recommendations regarding the use of the term “abuse-deterrent,” the development of guidance addressing additional abuse-deterrent technologies, the scrutiny applied to Tier 1 studies, and the enforcement of post-marketing study requirements for reference products.
Read More »On Health Policy
NCHR Testimony at 2016 FDA GDUFA Regulatory Science Meeting
May 20, 2016. Generic drug research and policies have an enormous impact on the health and safety of millions of Americans and impact patient and prescriber confidence in generic drugs. We urge you to consider research that will improve drug quality through rigorous manufacturer inspections, increase patient safety through the communication of important drug information on generic drug labels, and promote the uptake of generic drugs where they have the potential to reduce cost and improve outcomes.
Read More »NCHR Email to Senate Staff: Don’t Gut the FDA
April 22, 2016. The House Appropriations bill for FDA includes riders that will harm your constituents by reducing the safety and effectiveness of drugs and devices. These provisions include dangerous sections of the House’s 21st Century Cures Act that the Senate HELP Committee rejected.
Read More »NCHR Testimony at 2016 FDA Advisory Committee Meeting on Opioid REMS
May 4, 2016. If we want to reduce deaths and addiction due to opioids in the United States, we must demand more from everyone involved. Prescribers must be better informed, REMS assessments must be more rigorous, and the data must be transparent.
Read More »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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