October 22, 2020: It is FDA’s job to make sure that a vaccine has meaningful benefits for the health and lives of most Americans, and especially those most at risk.
Read More »On Medical Treatments & Products
NCHR’s Statement at FDA Advisory Committee Meeting on Olanzapine and Samidorphan Combination Tablets
October 9, 2020: Although patients may benefit from olanzapine/samidorphan by experiencing lower weight gain, the risks are too high to justify approval.
Read More »NCHR’s Testimony at FDA Advisory Committee Meeting on “Abuse-Deterrent” Amphetamine Sulfate Immediate-Release Oral Capsules
October 8, 2020: The drug should be labeled with an accurate description of its properties, not “abuse deterrent,” so that patients, family members, and healthcare providers do not erroneously assume the drug is less addictive.
Read More »NCHR Public Comments on the AHRQ Draft Systematic Review of Cervical Ripening in the Outpatient Setting
September 28, 2020: We support the review’s examination of the relative risks and outcomes of cervical ripening in the outpatient compared to the inpatient setting. However, an overarching problem in the review is that it does not examine the role of patient-centered outcomes and satisfaction.
Read More »NCHR’s Testimony to FDA Regarding Reclassification of 4 Medical Devices
September 8, 2020: NCHR’s Dr. Meg Seymour expressed concern about the lack of sufficient public
information available to evaluate the reclassification of four medical devices. Her testimony
emphasized that FDA executive summaries provide minimal details about study design, patient
demographics, and clinical endpoints, making it impossible to determine if the proposed special
controls would adequately mitigate risks.