In September 2020, medical and public health experts wrote to the FDA
Commissioner to express concern about political influence on FDA’s COVID-19 vaccine
decision-making, saying it could potentially compromise scientific integrity and public trust. The
open letter called on Commissioner Hahn to ensure vaccine approvals remain independent,
transparent, data-driven, and free from partisan pressure, urging actions like consulting with
other scientific bodies before issuing emergency authorizations.
We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
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.
NCHR’s Comments on the Petition for Extension of Premarket Tobacco Product Application Filing Deadline from Keller and Heckman LLP
We strongly oppose the requested extension of the deadline for premarket tobacco product applications (PMTAs), and we urge the FDA to not grant this requested extension.
Read More »NCHR Comments on Asymptomatic Carotid Artery Stenosis Screening
August 31, 2020. We support the USPSTF’s reaffirmation of the “D” grade recommendation first issued in 2014 against screening for asymptomatic carotid artery stenosis in the general adult population.
Read More »NCHR’s Public Comments on the FDA’s Draft Guidance Regarding the Development of Anti-Infective Drug Products for the Pediatric Population
August 31, 2020: We have several recommendations regarding the FDA’s draft guidance regarding the development of anti-infective drugs for the pediatric population.
Read More »