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.

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NCHR Letter to the Senate on Right To Try

March 23, 2018. We are writing to urge you to vote against the Right to Try bill that recently passed the House of Representatives (HR 5247) despite strong opposition from the Democratic leadership. Although HR 5247 includes some potentially useful requirements that the results of patients’ access to experimental drugs be made available to the FDA, so that they will be aware of serious harm that could be caused, there is no enforcement mechanism to make sure that information is made available.

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Right To Try Fact Sheet

The Right to Try bill creates a program that is not as good as the existing FDA “Expanded Access” program, which has approved 99% of requests they received.

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NCHR, NWHN, and OBOS Comments to USPSTF on Behavioral Weight Loss Interventions

March 19, 2018. We support the USPSTF draft recommendation for behavior-based interventions for weight loss to prevent obesity-related health problems and death. We further support USPSTF’s efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services. As more information becomes available, we encourage the re-evaluation and potential development of additional recommendation to improve the health of individuals with weight-related health concerns.

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