Testimony of Dr. Jennifer Yttri on pedicle screw spinal systems

May 22, 2103 — Pedicle screw systems are used to stabilize the spines of patients who need spinal fusions to correct spine injuries, deformations, or degeneration. Dr. Yttri pointed out the lack of clear clinical evidence that pedicle screw systems are beneficial for patients and how the FDA should require clinical testing before approving new devices. Continue reading

NRC and Patient, Consumer, and Public Health Coalition comments to FDA: Don’t need a new pathway for antibiotics for limited populations!

January 30, 2013 — The FDA considered a new way to approve drugs for use in small patient populations. NRC warn that such a pathway would put patients at risk of harm by giving them poorly studied drugs without knowing if the drugs provide any benefit. Continue reading

Statement of Dr. Diana Zuckerman Regarding Legislation to Require Warning Letters to Women with Dense Breasts To Nevada Assembly

March 11, 2013 — Among experts in women’s health and experts in breast cancer, there is considerable concern about Assembly Bill 147 and similar legislation in other states. While we agree that women with dense breasts should discuss the implications of that health condition with their physician, we are concerned that women who receive required form letters are more frightened than informed. Continue reading

Testimony of Dr. Jennifer Yttri on Bedaquiline

November 28, 2012 — Dr. Yttri testifies to the FDA Committee that the data on bedaquiline indicate that the benefit to patients with multi drug resistant tuberculosis is questionable. The FDA’s responsibility is to approve drugs that will help, not harm, consumers. Treatments exist for patients with multi drug resistant tuberculosis that are safer without the addition of bedaquiline. Continue reading

Statement by Senior Fellow Jennifer Yttri, PhD, at FDA Public Hearing on Antiseptic Preoperative Skin Preparation Products

December 10, 2012 — Dr. Yttri testifies to the FDA on the serious public health issue of contamination of antiseptic products. First, we support the recommendation of the August 2009 Advisory Committee in ensuring that all antiseptic patient preoperative skin preparation products are held to current good manufacturing practice (GMP) standards. Second, the FDA should remove ineffective antiseptics from the market. Third, as extrinsic contamination accounts for the majority of contamination outbreaks, FDA should require product packaging that would reduce extrinsic manipulation. Finally, while the majority of outbreaks seem to be related to extrinsic contamination, intrinsic contamination introduced during manufacturing most likely accounts for a greater number of contaminated products. Continue reading

Statement from Dr. Jennifer Yttri, senior fellow, at the FDA public hearing establishing a list of qualifying pathogens for the GAIN act

December 18, 2012 — Dr. Yttri testifies to the FDA that the growing risk of antibiotic resistant pathogens and need for development and responsible use of new antibiotics are critical public health concerns that need to be addressed. Continue reading

Testimony of Brandel France de Bravo, MPH On External Counter-Pulsating (ECP) Devices

December 5, 2012 — We do not support the FDA’s recommendation to down-classify ECPs for refractory chronic stable angina. We would support allowing the ECPs that are currently on the market to be allowed to stay on the market with labeling to include the phrase “all 510(k) cleared ECPs are prohibited from being used for any indication other than refractory chronic stable angina.” We urge you to require all new versions of ECPs to be classified as Class III and go through the more rigorous PMA process for any uses. Continue reading

Testimony of Dr. Diana Zuckerman, President at the FDA Advisory Committee Hearing on Metal-on-Metal Hip Implants

June 27, 2012 — Metal-on-metal hip implants were approved by the FDA without requiring clinical studies before approval or following patients after their surgery for potential side effects. Now, 500,000 patients have metal-on-metal implants that have been widely reported to wear down and create metal debris inside patients’ bodies. Dr. Zuckerman testifies to the FDA about the lack of long-term clinical trials at their Advisory Committee hearing. Continue reading

Statement of Paul Brown, In Support of the Ensuring Safe Medical Devices for Patients Act

March 15, 2012 — Paul Brown, NRC’s Government Relations Manager released a statement supporting Senator Merkley’s bill, “Ensuring Safe Medical Devices for Patient Act” that requires the Food and Drug Administration (FDA) to establish a Unique Device Identifier (UDI) rule by the end of year and add medical devices to the Sentinel system. Continue reading

Testimony of Dr. Diana Zuckerman on Transvaginal Mesh

September 9, 2011 — We agree with the FDA that serious adverse events from mesh are NOT rare. No man or woman wants to suffer from incontinence, but there is no doubt that the terribly painful complications can be much worse than the incontinence that initially led to surgery. And, those complications are often impossible to repair. Continue reading

Circulatory System Devices Panel Meeting: Slide Presentation- Diana Zuckerman, Ph.D President, National Research Center for Women & Families

January 25, 2011 — Researchers have reported that more than 20 percent of the almost one million AEDs in circulation were recalled by the FDA. Hundreds of people have died due to AED malfunctions. Innovation in design isn’t worth anything if the product doesn’t work when needed. Continue reading

Statement of Diana Zuckerman, Ph.D., President National Research Center for Women & Families at the FDA Advisory Committee Meeting on Lorcaserin

September 16, 2010 — In addition, I am a fellow at the University of Pennsylvania Center for Bioethics, and a board member for two nonprofit organizations that work to improve resources for the FDA: the Alliance for a Stronger FDA, and the Reagan Udall Foundation. Continue reading

Statement of Diana Zuckerman, Ph.D., President National Research Center for Women & Families at the FDA Advisory Committee Meeting on Meridia

September 15, 2010 — The big questions facing you is: how dangerous is Meridia; do the benefits outweigh the risks and if so, for whom; and is there any way to control its use so that those who would truly benefit from Meridia can buy it, but those who are likely to be harmed by it can’t buy it. Continue reading

Statement of Diana Zuckerman, Ph.D., President, at the FDA Public Meeting on the Reauthorization of the Medical Device User Fee Act (MDUFA)

September 14, 2010 — My perspective is as a researcher trained in epidemiology and public health at Yale Medical School, with experience doing research at Vassar and Harvard, as a fellow at the University of Pennsylvania Center for Bioethics, and as a former Congressional staffer focused on FDA issues. Continue reading

Statement of Diana Zuckerman, Ph.D., Regarding Senate Bill 213 “Child Care Articles and Toys Containing Bisphenol-A – Prohibition”

February 17, 2010 — Bisphenol A (BPA) is a chemical used to make plastics, and is frequently used in baby bottles, water bottles, and medical devices. It is also used in an epoxy coating on the inside of almost all food and beverage cans-including infant formula cans. Continue reading

Testimony of Dr. Diana Zuckerman to the FDA Public Hearing on Promotion of Medical Products via the Internet and Social Media

November 12, 2009 — Those of us who are here know that our concerns are shared by many other public health, patient, and consumer organizations. However, most do not have the staff or resources to set aside two days of unscheduled time for a meeting, especially non-reimbursed time, and especially in the middle of the health care reform negotiations. Continue reading

Statement of Diana Zuckerman at the FDA Science Board Meeting on the Use of Bisphenol A in Food Containers

February 24, 2009 — We were very pleased with the Science Board’s criticisms of the FDA Draft report on BPA and were disappointed that the FDA has not acknowledged the bottom line criticism: that the FDA drew conclusions about the safety of BPA that were not based on sound science, and that no conclusions can be made about safety until the FDA pays attention to the best studies conducted by federally funded scientists and designs appropriate follow-up research. Continue reading

Statement of Diana Zuckerman, Ph.D., President, National Research Center for Women & Families At the FDA Advisory Panel Meeting, Regarding the NeuroStar TMS System for Major Depression

January 26, 2007 — Depression is a serious and debilitating disease. The use of ineffective treatments can contribute to feelings of hopelessness, which in turn can worsen the symptoms and even result in suicide. Continue reading

Invited Testimony of Diana Zuckerman, PhD, Before the Standing Committee on Health, Canadian Parliament, Ottawa

June 8, 2006 — Clinical trials are a major source of information on the short-term risks of silicone breast implants. In clinical trials, the goal is to follow women prospectively to determine what complications and health problems occur, and to compare that to a control group. Continue reading