September 13, 2017. An effective shingles vaccine is important for public health. As patients get older, they are more likely to develop long-term pain, or post-herpetic neuralgia (PHN), as a complication of shingles. This pain can be severe and chronic. There is no cure, and treatments do not reliably relieve pain for all patients. The only way to reduce the risk of developing shingles and PHN is to get vaccinated. We urge this Advisory Committee to recommend that the FDA require critical post-approval long-term studies to further evaluate the efficacy and safety of Shingrix. We also strongly recommend that the company conduct subgroup analyses to ensure that the vaccine is safe and effective for both women and men and also people of color.
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NCHR Testimony at the FDA about Pediatric Labeling for Butrans
September 14, 2017. It is important for this panel and the FDA to make decisions about drug labeling based on good science and strong data. We concur with the 2016 Advisory Committee that because pediatric patients are vulnerable to drug use and addiction due to ongoing brain development; proper prescribing, patient selection, and education are crucial to optimize safety in this population. Results of Study 3031 do not provide sufficient evidence to inform health care providers about the safe use and proper dosing of Butrans in the management of pain for pediatric patients. We urge this Advisory Committee to advocate for pediatric patient safety and urge the FDA to require that the drug be appropriately evaluated before allowing information about Butrans to the pediatric section of the labeling.
Read More »NCHR Comment on the USPSTF’s Draft Recommendations for Hepatitis B Virus Infection Screening in Pregnant Women
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.
Read More »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.
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