October 7, 2016. We continue to strongly urge Sarepta to do the studies needed to support their claims that patients benefit from Exondys 51, and in the meanwhile Sarepta should ensure that patients in those studies receive the treatment for free.
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NCHR Testimony at 2016 FDA Workshop on Drugs and Biological Products Used During Lactation
April 28, 2016. More clinical studies are desperately needed to determine the safety of drugs in lactating mothers. When these studies are in the planning stages, be cognizant of enrolling mothers that represent a wide diversity of races, ethnicities, and–when appropriate for the drug–ages.
Read More »NCHR Testimony at MEDCAC Concerning Treatment Resistant Depression
April 27, 2016. Testimony at Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) regarding the definition of treatment resistant depression, the use of the definition in clinic and research, and research concerning treatment resistant depression.
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.
Read More »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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