NCHR Testimony on SABER-Bupivacaine for Post-Surgery Pain Relief

January 16, 2020. There is not good evidence that SABER-bupivacaine provides a meaningful benefit to patients, and certainly not proven that the benefits outweigh the possible risks.  Most important, the sponsor has not proven that this formulation of the drug works better or is safer than the opioid, bupivacaine. Bupivacaine itself has been on the market for decades, is available as a generic, and does not have these new safety concerns. Thus, there is no reason to approve this drug just to have “another tool” when there is no evidence that it is a better tool than currently available options.

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NCHR Testimony on Singulair and Neuropsychiatric Side Effects

September 27, 2019. Singulair has serious side effects and we need much better data to determine the likely benefit and risk of harm for patients. FDA has an important role to play in encouraging this research. In the meantime, patients, parents, and clinicians must be given clear information about the risks so that they can make an informed decision about whether to use montelukast (Singulair).

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NCHR Testimony on Brexanolone for Postpartum Depression

November 2, 2018. We urge the committee to require more persuasive evidence on the safety of this drug. It is our moral obligation to patients to make sure that all drugs with this risk potential are scrutinized and held to a higher standard in the approval process.  

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