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 Comments On Emergency Authorization for New COVID-19 Drug

November 9, 2022: FDA Advisory committee considers EUA emergency authorization of new COVID-19 treatment. NCHR says study is small and flawed and additional data are needed and FDA advisors agree.

NCHR’s Comment for the Clinical Laboratory Improvement Advisory Committee

November 7, 2022: NCHR urges CLIAC to amend its Clinical Laboratory Improvement Amendments (CLIA) of 1988 because CLIA needs to better reflect the advancements in science and technology that occurred over the past two decades. Current CLIA standards have numerous limitations and deficiencies that must be addressed. Two examples include the accuracy of lab-developed diagnostic tests and the electronic health records and software prompts used by physicians across the country.

Testimony of Dr. Diana Zuckerman About I-omburtamab FDA Advisory Committee Meeting

October 28, 2022: Dr. Diana Zuckerman testified at the FDA Advisory Meeting on I-omburtamab, a drug for children’s brain cancer (relapsed neuroblastoma). She agreed with the FDA that the company’s studies had no adequate control group, making it impossible to determine if the treatment worked better than placebo. Therefore, despite the urgent unmet need, the drug does not meet the required standard of evidence for FDA approval. We hope the company will make the drug available for free through the FDA’s Expanded Access program for experimental drugs.

NCHR Testimony at FDA Advisory Panel on Wound Dressings

October 26, 2022: Dr. Diana Zuckerman testified at the FDA Advisory Meeting on Wound Dressings. She pointed out that data on safety and effectiveness is lacking for these products even though they have been used for decades. Thousands of adverse event reports to FDA indicate contamination and problems with sterile packaging. FDA should classify them as Class III and require clinical trials and inspections.

NCHR Speaks out on the Dept. of Veteran’s Affairs’ decision to cover abortion and abortion counseling

October 11, 2022: Women veterans number about two million and make up the fastest-growing group of veterans in the U.S. today. We commend the Department of Veterans Affairs for its decision to expand healthcare coverage for women veterans to include abortion and abortion counseling. This action will help ensure that veterans and their beneficiaries have access to a full complement of reproductive healthcare regardless of where they live.