NCHR Comments on Approval of Abuse-Deterrent Labeling for Oxycodone Hydrochloride

July 26, 2017. To reduce the opioid epidemic, the FDA must hold pharmaceutical companies to a high standard with clear evidence. We do not believe IPC Oxy should be designated as abuse-deterrent unless that is clearly proven as we are concerned about unexpected impacts of the formulation without pharmacokinetic and clinical abuse potential studies. We urge the Committee to vote that there is not sufficient data for this product to support inclusion of language regarding abuse-deterrent properties in the product label for the IV route of administration.

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NCHR Testimony at FDA Meeting on Pediatric Cancer Drugs

June 21, 2017. Drug efficacy is a complex issue for children with chronic and/or rare diseases like the cancers discussed here. We commend the FDA and this committee for providing an open discussion focused on the best ways to test these five new drugs in pediatric populations. This marks a positive effort to help ensure that drugs are safe and effective for everyone for whom they are prescribed, particularly when the cost of these drugs can be so high.

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NCHR Testimony to FDA on Victoza to Prevent Cardiovascular Events

June 20, 2017. In summary, there are questions relating the LEADER trial that raises questions about its generalizability. With only one study, however large, we don’t even know if the results would be replicated. The LEADER study suggests that the drug does not significantly increase cardiovascular risk. However, the sponsor has not demonstrated that it reduces cardiovascular risk, especially not for U.S. patients whose BMI, diet, and exercise habits might be quite different from those in other countries.

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NCHR Testimony to FDA About L-Glutamine for Sickle Cell Crisis

May 24, 2017. Sickle cell disease and the crises that it causes are a serious problem. Patients deserve and need new treatments. This requires high-quality clinical studies to demonstrate whether new treatments are effective and safe. When many of the patients that start a study drop out before it is completed, it is impossible to accurately evaluate the benefits compared to the risks. … FDA should approve new treatments based on clearly demonstrated evidence of efficacy and safety. This requires high-quality clinical trials where post patients stay in the trial. FDA should not approve a drug with questionable benefit when the dropout rate is concerning.

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