Comments on proposed order “Physical Medicine Devices: Reclassification and Renaming of Shortwave Diathermy of All Other Uses”

To view as PDF, click here. Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 May 21, 2014 Comments of the National Center for Health Research On proposed order “Physical Medicine Devices: Reclassification … Continue reading

Statement of Laurén Doamekpor on the Importance of Including Women, Minorities, and the Elderly in Studies of the Safety and Effectiveness of New Drugs and Devices (FDASIA Section 907 Hearing)

The responsibility of collecting sufficiently representative demographic subgroup data sits solely on the shoulders of device and drug companies. The companies know how to persuade – they do it everyday in commercials. Similarly, if they identify persuasive incentives for patients to participate in studies, and minimize disincentives, patients will participate and be available for follow-up. Continue reading

Testimony of Anna E. Mazzucco, Ph.D. on Iontophoresis Devices

February 21, 2014. Class III devices are defined by “potential unreasonable risk of illness or injury”. Based on that definition and the information that was provided to the committee and the public for this meeting, we are convinced, as FDA was for 2 decades, that iontophoresis devices are Class III devices that should be reviewed under the more rigorous PMA process. Continue reading

Comments on the FDA’s Proposed Rule “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”

As members of the Patient, Consumer, and Public Health Coalition, we are pleased to have the opportunity to strongly support the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985). Continue reading

Comments on the FDA’s Draft Guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act”

As members of the Patient, Consumer, and Public Health Coalition, we conditionally support the draft guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (FD&C) because it clarifies FDA enforcement actions that can be taken against individuals or firms that illegally make drugs under the banner of traditional compounding. Continue reading

Public Comments on NIOSH Draft Intelligence on Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace

December 16, 2013. When notorious and decades-known carcinogens such as asbestos and radon are still present at unsafe or unknown levels in American workplaces, how can the public have confidence that our regulations can handle new and complex occupational hazards arising every day? Only a few hundred out of more than 80,000 chemicals in use in the United States have been tested for safety. We should be concerned. Continue reading

Testimony of Dr. Anna E. Mazzucco on Classification of Stair-climbing and Mechanical Wheelchairs

Stair-climbing wheelchairs are have been considered high risk – Class III – and have been required to submit studies of safety and effectiveness under the PMA review process. The proposed order being considered today would reclassify stair-climbing wheelchairs into Class II indicating moderate risk, and reviewing it through the 510(k) process. Continue reading

Comments on the NIH Office of Disease Prevention Strategic Plan for Fiscal Years 2014-2018

November 22, 2013 — While improvement in public health measures can be more challenging to assess, and requires a longer time period to evaluate, the goal of prevention research should be focused on measurable health outcomes, and not simply on the number of grants or scientific publications. A more explicit identification and prioritization of research goals would increase confidence that meaningful public health results will be achieved where they are most urgently needed. Continue reading

Comments on FDA Safety and Innovation Act Section 907 Report

November 20, 2016 — The National Research Center for Women & Families strongly supports the requirement of the Food and Drug Administration Safety and Innovation Act (FDASIA) for an action plan to include demographic subgroups in clinical trials and data analysis. Greater diversity in clinical trials, analyzing subgroup data, and reporting the results and explaining the implications in product labels and MedGuides will shed light on which medical products are safe and effective for which demographic subgroups, including racial and ethnic minorities. Continue reading

Testimony of Dr. Caitlin Kennedy on Expanded Indications for Medtronic Cardiac Resynchronization Therapy Devices

October 8, 2013 — I am Dr. Caitlin Kennedy and I am speaking on behalf of the National Research Center for Women & Families and our president, Dr. Diana Zuckerman. We oppose the expansion of indications for Cardiac Resynchronization Therapy Devices. We urge you to require more testing to prove that the benefits of these devices outweigh the risks for these new indications in general and for particular demographic subgroups. Continue reading

Comments on Reclassification of Cardiovascular Devices; Intra-Aortic Balloon and Control Systems

September 17, 2013 — As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA’s proposed order for Intra-Aortic Balloon and Control Systems (IABP) devices used to treat septic shock or pulsatile flow generation (Other Specific Intended Uses) to remain in Class III with Premarket Approval applications (PMA) required. Continue reading

Testimony of Dr. Caitlin Kennedy, on reclassification of External Pacemaker Pulse Generator Devices

September 11, 2013 — We strongly oppose the reclassification of External Pacemaker Pulse Generator Devices from class III (high risk devices) to class II (moderate risk devices). We urge you to recommend that these devices should remain class III and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices and because clinical data are urgently needed to provide useful information to health professionals about the benefits and risks. Continue reading

Comments on Proposed Order “Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs”

September 10, 2013 — As members of nonprofit patient, consumer, and public health organizations, we oppose the FDA proposed order that will reclassify stair-climbing wheelchairs (a Class III device, indicating high risk) into Class II (moderate risk). This change in classification would result in greater risk for some of our nation’s most vulnerable consumers.
Continue reading

Comments of the Patient, Consumer and Public Health Coalition to FDA on “Ensuring Access to Adequate Information on Medical Products for All”

September 9, 2013 — Comments of the Patient, Consumer and Public Health Coalition to FDA on “Ensuring Access to Adequate Information on Medical Products for All.” We are writing to express our strong support for the FDA’s efforts to improve how it communicates information on medical products to all Americans, and especially underrepresented subpopulations. Continue reading

Testimony of Brandel France de Bravo, MPH, on Computed Tomography Colonography

September 9, 2013 — We agree with the Task Force that at this point, there is no reason to recommend virtual colonoscopies for most patients who need screening. We would add, however, that if specific patients are unwilling to undergo regular colonoscopies, then a virtual colonoscopy is a reasonable alternative. Continue reading

Comments on Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina

August 19, 2013 — We are writing as members of the Patient, Consumer, and Public Health Coalition to express our concerns about the proposed down-classification from Class III to Class II of External Counter-Pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization.  We strongly support the proposed PMA for other indications for the same ECP devices. Continue reading

Comments of the Patient, Consumer, and Public Health Coalition on Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning

August 7, 2013 — Over 30 million Americans, including 2 million adolescents between age 11 and 18, use tanning devices each year. Those who began using tanning beds before age 30 are 75 percent more likely to develop cutaneous melanoma, a potentially fatal cancer. Continue reading

Comments to FDA on “New Approaches to Antibacterial Drug Development”

July 30, 2013 — As members of the Patient, Consumer, and Public Health Coalition, we recognize the need for new drugs to reach patients with serious or life-threatening diseases. The pipeline for new antibacterial drugs is shrinking. However, we have grave concerns about proposals to change the standards for meeting FDA’s requirement of two “adequate and well controlled” trials. Continue reading

Comments on proposed order “Requests for Ban or Standard on Adult Portable Bed Rails”

July 30, 2013 — Comments of the National Research Center for Women & Families on Proposed Order “Requests for Ban or Standard on Adult Portable Bed Rails”: We are writing to urge the Consumer Product Safety Commission to take strong action to protect consumers from dangerous bed rails by either:
1) Establishing mandatory safety standards for adult portable bed rails with adequate warning labels, OR
2) Banning these bed rails if it is determined that they cannot be made safe. Continue reading

Testimony of Dr Jennifer Yttri, senior fellow, at FDA Advisory Committee on reclassification of blood lancets

June 26, 2013 — Blood lancets, used to test blood sugar levels in diabetics or to obtain blood samples from finger pricks, have been considered a low risk medical device, like band-aids. However, FDA and CDC have found that blood lancets being used on multiple patients have resulted in increasing numbers of hepatitis outbreaks. In a statement to the FDA, NRC made the claim that blood lancets are medium and high risk devices, that require more regulation than low risk devices. Continue reading

Testimony of Dr Jennifer Yttri, senior fellow, at FDA Advisory Committee on sorbent hemoperfusion systems

June 27, 2013 — These systems are used to filter toxins out of the blood . However, there is not proof that the devices save the lives of patients who are poisoned, have a drug overdose, or are in a coma from liver failure. Because of this lack of evidence, Dr Yttri and the NRC argued that these devices need to undergo clinical testing. Continue reading

Testimony of Dr Jennifer Yttri, senior fellow, at FDA Advisory Committee on implanted blood access devices

June 27, 2016 — FDA wanted to change implanted blood access devices, like catheters and cannulas, from a Class III device (highest standards) to a Class II device (lower standards). Senior fellow, Jennifer Yttri, spoke on behalf of NRC about how reclassification would limit the ability of FDA and patients to request more safety and efficacy testing and remove faulty devices from market. Continue reading

Comments on Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System

June 24, 2013 — As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA proposed order that will require the premarket approval application (PMA) for Automated External Defibrillators systems (AEDs). However, we oppose the FDA exercising an enforcement discretion that would allow 510(k) cleared AEDs to remain on the market for 15 months after FDA issues a final order requiring a PMA for these devices. Continue reading

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

Comments to the FDA on “Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis”

May 8, 2103 — The National Research Center for Women & Families and the TMJ Association oppose the reclassification of Temporary Mandibular Condyle prosthesis, a preamendments class III device, into class II. The proposed special controls are not rigorous enough to provide a reasonable assurance of the device’s safety and effectiveness. Continue reading

Comments on Proposed Order Regarding Transilluminator for Breast Evaluation

May 6, 2103 — 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, 2103 — 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, 2103 — 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 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!

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

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

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

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

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

March 19, 2012 — 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

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

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

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