May 2, 2018, We urge the panel to recommend that FDA require additional well-designed superiority studies that use appropriate statistical methods to determine whether plazomicin cures infections and saves lives for patients who have no other options. With reliable methods, even small studies can show a clinically meaningful and significant benefit. Since there is no evidence that plazomicin works or is safe for patients who have no or limited options, approval will do more harm than good.
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Statement Regarding FDA Restrictions on Essure Sterilization Device of Dr. Diana Zuckerman, President of the National Center for Health Research
April 9, 2018. The FDA announced restrictions on the sale and distribution of Essure and a requirement that women receive risk information. But, the checklist that is meant to help inform women has clear problems, and the information in it has been questioned by experts in the field.
Read More »NCHR Testimony at FDA on Eversense Continuous Glucose Monitoring System
March 29, 2018. In conclusion, patients with insulin dependent diabetes need better solutions to monitor and manage their disease. There is currently no proof that the benefits of Eversense outweigh the risks. We need additional clinical evidence before the FDA should decide whether or not to approve it.
Read More »NCHR Testimony at the FDA about a Drug for Opioid Withdrawal Symptoms, Lofexidine
March 27, 2018. Patients undergoing opioid withdrawal need non-opioid effective treatment alternatives. In order to ensure the we are doing more good than harm, the FDA must ensure that treatments show substantial evidence of effectiveness. Current data indicate that lofexidine can successfully provide short-term relief of patients’ opioid withdrawal symptoms following abrupt discontinuation. However, due to cardiac safety risks, this drug should not be indicated for individuals with existing cardiac conditions, and if approved, there should be a clear warning on the drug’s label. Finally, the sponsor has not provided sufficient evidence that lofexidine increases the likelihood that individuals will complete withdrawal treatment and, ultimately, move toward ending their physical dependence on opioids. We believe they must do so in order to receive this indication.
Read More »NCHR Testimony at the FDA on an Oral Drug for Ulcerative Colitis
March 8, 2018. We are concerned that the clinical trial data do not adequately represent the real-world population of patients who will be likely to consider this drug. We strongly recommend more persuasive data including a more diverse group of patients before making a decision about supplemental approval of the two proposed dosing regimens for induction non-responders and those with prior TNF blocker failure.
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