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

July 28, 2017. 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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Patient, Consumer, and Public Health Coalition Letter to Senators Opposing the “Right to Try” Law

July 31, 2017. Sen. Johnson’s proposal would remove FDA from the process, allow companies to charge whatever they want, not allow FDA to consider any harm that the experimental drug causes when used under the Right To Try auspices, and thus eliminate the safeguards and monitoring that otherwise are done to determine whether the patient has been helped or harmed by the experimental drug.

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NCHR Response to Senate Health bill

July 28, 2017. All three versions of the so-called Better Care Reconciliation Act of 2017 would have resulted in much worse, not better, health care for Americans than our current healthcare program.

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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 Comments on CPSC Agenda and Priorities for FY2018-2019

July 26, 2017. We are very concerned about exposures to phthalates in children’s toys and other products as well as endocrine-disrupting chemicals and other safety concerns related to recycled tire crumb rubber and other artificial turf (including “poured in place” surfaces).

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