August 9, 2017. We support the USPSTF’s draft recommendation for Hepatitis B screening in pregnant women. Universal screening and prevention programs for pregnant women with Hepatitis B can help to identify pregnant women who are at risk for passing the virus to their children. Preventing vertical transmission protects children from a potentially serious disease and other diseases that may develop as a result, such as cancer; protects others who may be infected; and allows children to participate in school and play activities important to their healthy development. Therefore, screening is highly beneficial for these children.
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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.
Read More »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.
Read More »NCHR Testimony at FDA Advisory Committee Oncology Meeting on Mylotarg (“GO”)
July 12, 2017. Given the research design, only one pivotal study, the lack of U.S. patients, and a less than convincing literature review, the data do not support sufficient support for approval. The studies, in our view, do not provide strong evidence that GO is effective and there are still continuing safety concerns.
Read More »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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