Public Comment Regarding Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway – March 10, 2025: We support the FDA’s decision to require that a confirmatory trial is “underway” before granting accelerated approval, but the definition of underway needs to be defined stringently and clearly. In our written public comment, we recommended setting specific benchmarks and stronger oversight to ensure timely trial completion so that patients and physicians can make informed medical decisions about products approved under the accelerated program. We also state that the closer to completion the confirmatory trial is at the time of accelerated approval, the more useful the research evidence is likely to be. We also urge that no exceptions be made to the requirement.
Statement of Dr. Diana Zuckerman At the FDA General and Plastic Surgery Devices Advisory Panel on ProSense Cryoablation System – November 7, 2024: We testified at an FDA Advisory Panel meeting to advise FDA whether ProSense Cryoablation can replace lumpectomy for older women with very early, low-risk breast cancer. This technique can freeze and destroy a tumor in a few minutes but the research was not well-designed to determine if it is as safe as lumpectomy, and if so, for which types of patients.
Testimony of Patient, Consumer, and Public Health Coalition at Patient Engagement Device Advisory Committee Meeting – October 30, 2024: Tess Robertson Neel testified at the FDA Patient Engagement Device Advisory Panel on behalf of the Patient, Consumer, and Public Health Coalition regarding informed consent. We support the FDA’s proposed improvements, suggests a short, easy to read checklist format to improve fully informed consent, and highlights the need to enforce FDA recommendations or improve incentives for compliance.
Testimony of Laura Lytle at the FDA Patient Engagement Device Advisory Committee Meeting – October 30, 2024: NCHR’s Laura Lytle testified at the FDA Patient Engagement Device Advisory Panel meeting in support of the FDA’s proposed guidance for informed consent, but suggested 4 key areas for improvement: using a short, simple checklist to ensure that patients understand the risks; focusing on informed consent as a process not a document; simple summaries of key information; and ensuring patient privacy.
Testimony of Grace Drew at the FDA Advisory Committee Meeting on Imfinzi for Resectable Non-Small Cell Lung Cancer – July 25, 2024: At the FDA Advisory Committee meeting on a new indication for Imfinzi (durvalumab), NCHR pointed out that the AEGEAN clinical trial did not assess if Imfinzi is necessary both before and after lung tumor surgery. We strongly support the FDA scientists who stated that the trials need to be redesigned to determine whether Imfinzi both before and after surgery is more beneficial compared to Imfinzi either before or after surgery.
CPTF Testimony at the FDA Listening Session on Advisory Committee Meetings – June 13, 2024: NCHR testified at the FDA listening session on Advisory Committee reform. We expressed concerns about committee members with conflicts of interest and that many Consumer Representatives on advisory committees do not actually represent consumer groups or perspectives.
Testimony of Dr. Diana Zuckerman at the Tobacco Products Scientific Advisory Committee Meeting on General Snus – June 26, 2024: NCHR testified at the FDA Advisory Committee about the problems with safety data for General Snus smokeless tobacco and questioned whether safer than cigarettes.
Our Written Testimony in Support of HB 457 for the Maryland House of Delegates Environment and Transportation Committee – February 16, 2024: NCHR provides written testimony to the Maryland House of Delegates Environment and Transportation Committee to support HB457, which requires transparency regarding all new artificial turf and infill installation, use, reuse, recycling, and disposal. This information would enable communities to make informed decisions about artificial turf that take into account how long it lasts and its impact on the environment.
Testimony of Diana Zuckerman at FDA Advisory Panel on Blood Irradiators – November 7, 2023: Blood irradiator devices have been used for decades on cancer patients to try to prevent metastasis. NCHR agrees with FDA there is no evidence that they benefit patients and it is clear the radiation can be harmful. At an FDA Advisory Committee meeting in November 2023, we urged FDA to finally require scientific studies if companies want to continue to sell these devices.
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.
Testimony of Diana Zuckerman at the Meeting of EPA’s National Environmental Justice Advisory Council on September 28, 2022 – September 28, 2022: I want to comment very briefly on the PFAS recommendations, since that’s an issue we’ve worked on for years. Let me add that we are very concerned about all endocrine disrupting chemicals not just PFAS.
Testimony of Dr. Diana Zuckerman About COPIKTRA FDA Advisory Committee Meeting on September 23, 2022 – Dr. Zuckerman of National Center for Health Research testified at FDA Advisory Committee in September 2022 about Copiktra for CLL and SLL. Compared to another treatment option that is no longer considered effective, Copiktra patients lived 11 months shorter with many serious problems harming quality of life.
Testimony of Dr. Diana Zuckerman About PEPAXTO FDA Advisory Committee Meeting on September 22, 2022 – We testified before the FDA Advisory Committee that Pepaxto should no longer be approved for multiple myeloma because new research shows that patients taking it died 5 months sooner than patients taking a different treatment.
Diana Zuckerman Statement on the Role of FDA in Health Inequities Meeting of the National Academy of Medicine – July 26, 2022: The National Center for Health Research testified before a meeting of the National Academy of Medicine in July 2022 regarding federal policies that could improve health equity and decrease racial and ethnic disparities. There are many reasons for health inequities, but we focused on federal laws regarding diversity in clinical trials. The U.S. Department of Health and Human Services requires research studies to include people representing diverse racial and ethnic backgrounds. NIH, CDC, SAMHSA and other federal health agencies make an effort to abide by this law. The one exception among federal public health agencies is the Food and Drug Administration (FDA), which encourages but does not require diversity in clinical trials. The agency’s justification is American taxpayers don’t pay for the studies – the companies that make the products pay for the studies. However, taxpayers pay for FDA staff that regulate these products, and taxpayers also pay for the products themselves.
Dr. Diana Zuckerman Statement to CDC Advisory Committee On Breast Cancer in Young Women – August 23, 2022: Today I want to mention an issue that hasn’t been talked about: fear. Research shows that many young women are disproportionately afraid of breast cancer and that young breast cancer survivors are more afraid of recurrence than older survivors. I encourage you to think of what we can do together to help reduce that fear so that young women don’t let their fear overwhelm them as they become aware of and educated about their risks as well as their prevention and treatment options.
Who Should You Believe? A critique of the Aesthetic Society’s view of Breast Implant Illness – A 2022 article in the Aesthetic Surgery Journal makes it clear that Aesthetic Society plastic surgeons are encouraging their members to pretend to share patients’ concerns about breast implant illness (BII) while persuading patients that BII is not real and therefore BII patients do not need explant surgery. A review of their poorly researched article explains which BII studies it ignored or misrepresented and raises questions about bias and gaslighting.
Public Comment PDUFA VII Commitment Letter (Docket #FDA-2021-N-0891) From the National Center for Health Research – October 28, 2021: CPTF comments on the proposed PDUFA VII Commitment Letter from the FDA.
Statement by Dr. Diana Zuckerman on Sintilimab at FDA Advisory Committee on Oncologic Drugs – February 10, 2022: CPTF president Dr. Diana Zuckerman testifies to the FDA Advisory Committee on Oncologic Drugs on Sintilimab.
Comments on CMS’s Proposed Decision Memo on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) – December 17, 2021: We are concerned with several major aspects of CMS’s discussion of Counseling and Shared Decision-Making for lung cancer screening.