Comments on Proposed Order Regarding Transilluminator for Breast Evaluation

May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for Transilluminator for breast evaluation devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness. Continue reading

Comments on Proposed Order Regarding Sorbent Hemoperfusion Devices

May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for sorbent hemoperfusion devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.[1] We strongly oppose down- classifying the devices for the treatment of poisoning and drug overdose. Continue reading

Comments on Proposed Order Regarding Cranial Electrotherapy Stimulator Devices

May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for cranial electrotherapy stimulator devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness. Continue reading

Comments from Members of the Patient, Consumer, and Public Health Coalition Re: HELP Committee’s Draft Proposal on Pharmaceutical Compounding

The Patient, Consumer, and Public Health Coalition expressed concern that the draft does not adequately address the public health threats posed by compounding pharmacies and will not do enough to prevent future health care crises. The Coalition provided comments on how to improve the draft to better protect the American public. Continue reading

Comments on Effective Date for Premarket Approval for Three Class III Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose

May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for the three preamendment devices referred to in this docket because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness. Continue reading

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

Notre Dame Football Players Rape Cover-up – What’s in the News and What Isn’t

Fem2.0 January 9, 2013. The media has extensively covered the college championship football game between Notre Dame and Alabama, but few Americans aware of Notre Dame’s cover-up of rapes by Notre Dame football players. Monday’s football game is an opportunity to acknowledge that raping women is a terrible crime that needs to be taken seriously by the police, the public, and the media. 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

Comments on Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses

October 4, 2012. Members of the Patient, Consumer, and Public Health Coalition strongly support the FDA’s proposed rule to require Premarket Approval Application (PMA) for the Class III preamendments device Shortwave Diathermy (SWD) for all other uses except for the treatment of malignancies. However, we oppose FDA’s proposal to allow a Product Development Protocol (PDP) instead of a PMA for this device because PDPs are for devices where a sponsor comes to an “early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.” FDA has stated unequivocally that SWD devices “have not been shown to be safe and effective” therefore, the devices have no public health benefits, and that also rules out the use of a PDP. 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

Comments on Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose; Effective Date of Requirement for Premarket Approval for Sorbent Hemoperfusion Devices To Treat Hepatic Coma and Metabolic Disturbances

May 17, 2012. To ensure public health and patient safety, sorbent hemoperfusion devices for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances should remain class III devices and go through the more stringent PMA process, which requires clinical trials and inspections. Continue reading

NRC Comment on a FDA Guidance on the Evaluation of Sex Differences in Medical Device Clinical Studies

The National Research Center for Women and Families has been a long-time advocate of medical device clinical studies including data on safety and effectiveness for women. In this comment letter to the FDA, we describe the importance of analyzing data for women separately and how this information should be used to help women and providers make the best informed decisions. 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

Comments on Proposed Rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

January 17, 2012. As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices. Continue reading

Report: Medical Devices Lack Evidence of Safety and Effectiveness

July 29, 2011. The prestigious Institute of Medicine (IOM) released a report on the Food and Drug Administration’s 510(k) medical device clearance process stating the system is “flawed” and should be revised. The report echoes the National Research Center for Women & Families’ concerns about the lack of evidence that these devises actually work and are safe. Continue reading

Study on Medical Device Recalls Released Today

February 14, 2011. Our new study finds that most medical devices recalled during the last five years for “serious health problems or death” were originally cleared (approved) by the Food and Drug Administration (FDA) using a less stringent process that does not require testing in patients. The study, released on-line on February 14 prior to publication in the Archives of Internal Medicine, was co-authored by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. 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