NCHR Testimony at the FDA about Hepatitis B Vaccine, Heplisav-B

We feel for the company because it has previously tried and failed to obtain approval. However, the bottom line is we don’t know how safe the vaccine is overall, and specifically how safe it is for Asians, who comprise the majority of patients living with chronic Hepatitis B. It is better for FDA to be cautious rather than approve a potentially dangerous vaccine – especially because other options are available. We strongly urge this Advisory Committee to prioritize patient safety and urge the FDA to maintain its scientific safety standards for approval and therefore recommend additional pre-licensure studies to further evaluate the safety of Heplisav-B in subpopulations who are disproportionately affected by both acute and chronic hepatitis-B infection.

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

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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