February 12, 2019. The data from the clinical trials for esketamine nasal spray are encouraging, but there are still important questions concerning its safety and efficacy.
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NCHR comments on FDA’s Framework for Real-World Evidence Program
February 5, 2019. FDA needs to maintain high standards for evidence of effectiveness and safety whether the source of the data is from traditional clinical trials or RWE. Double-blind, randomized clinical trials remain the gold standard, and along with other types of well-controlled trials (including those that generate RWE), provide information that observational studies cannot. RWE should supplement rather than replace traditional, randomized and blinded controlled clinical trials except in situations where such traditional clinical trials are not possible.
Read More »NCHR Testimony on Brexanolone for Postpartum Depression
November 2, 2018. We urge the committee to require more persuasive evidence on the safety of this drug. It is our moral obligation to patients to make sure that all drugs with this risk potential are scrutinized and held to a higher standard in the approval process.
Read More »What Would Impact of 21st Century Cures Act be on Your Healthcare Costs and the Lives of Alzheimer’s Patients?
The BMJ, November 23, 2015. A controversial proposed new health law would have had a terrible impact on the lives of Alzheimer’s patients and their families, who would have spent billions on medications that don’t work and can cause cancer.
Read More »Statement of NCHR At the April 8, 2009 FDA Psychopharmacologic Drugs Advisory Committee Meeting Regarding Seroquel XR
April 8, 2009. We testified arguing that Seroquel, an Antipsychotic medication, should be kept off the market as it has not been conclusively proven that it does not increase the risk of diabetes or tardive dyskinesia.
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