September 10, 2019: In response to FDA’s request for public comments, we stated that the agency should require better testing of hormonal birth control pills and patches. Current studies don’t include enough women with higher BMIs or track blood clot risks properly. Our comments push for stronger safety standards that test hormonal contraceptives on women of all weights, especially since some birth control methods may be less effective or more dangerous for larger women.
Read More »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 Comment on USPSTF Draft Recommendation on Illicit Drugs Use Screening
September 9, 2019. We strongly encourage the USPSTF to delay recommendations until they obtain evidence to ensure that screening for illicit drug use does not have unintended consequences that outweigh any benefits.
Read More »NCHR Comments on FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations
August 6, 2019. There are reasons why a drug or device may be less safe or less effective for women, children, older patients, or certain ethnic or racial subgroups. These differences in results for under-represented subgroups may not be minor or trivial. This is why sufficient inclusion of under-represented groups is so important.
Read More »NCHR Testimony on Descovy for PrEP
August 7, 2019. We understand the desire to provide a new PrEP treatment indicated for a broad population, especially when that new treatment is expected to potentially have fewer risks for kidneys and bone density. However, it is inappropriate and potentially dangerous to approve this drug for subgroups of patients that haven’t been adequately studied. The FDA law requires substantial evidence that the benefits outweigh the risks for each subpopulation that the new indication would include.
Read More »NCHR Testimony on Nintedanib for SSc-ILD
July 25, 2019. There is a critical need for new treatments for SSc-ILD. We all hope that Nintedanib [brand name OFEV] will help slow the rate of decline, but the data are not yet sufficient.
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