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

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

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

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

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

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

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

Statement of Diana Zuckerman, Ph.D. President National Research Center for Women & Families Regarding Senate Bill 1449 Bisphenol A-Free Children and Babies Act

FEBRUARY 1, 2010 Thank you for the opportunity to testify about Senate Bill 1449 on behalf of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund. Our Center is dedicated to improving the health … 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