Comments on Distributing Risk Information for Approved Prescription Drugs and Biological Products

August 25, 2014. As members of the Patient, Consumer and Public Health Coalition, we strongly urge the Food and Drug Administration (FDA) to withdraw its draft guidance proposing to allow pharmaceutical firms to distribute to health care providers and facilities scientific medical literature suggesting that the risk information for prescription drugs and biological products are less than what is stated in the FDA-approved product labeling. Continue reading

Comments on the Up-Classification of Flu Detection Tests

Members of the Patient, Consumer, and Public Health Coalition strongly support the up-classification of influenza detection devices. We support moving the devices from class I to class II with special controls and into a new device classification regulation (from 21 CFR 866.3330 to 21 CFR 866.3328). We agree with the FDA that “the accuracy of these devices has serious public health implications,” since influenza can cause serious illness and death. Continue reading

Statement of Anna E. Mazzucco, Ph.D. before the 2014 National Antimicrobial Resistance Monitoring System Scientific Meeting

August 13, 2014. We urge the participating agencies to ensure that NARMS receives the funding that it needs to maintain and build upon these vital efforts. Antibiotic resistant infections are estimated to cost the U.S. healthcare system between $21 and $34 billion dollars every year. Continue reading

Comments on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance for the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.” We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.” Continue reading

Comments on proposed rule to allow FDA to regulate all tobacco products

As members of the Patient, Consumer, and Public Health Coalition we are writing to comment on various aspects of the proposed rule to extend FDA’s jurisdiction to tobacco (including made or derived from tobacco) products other than cigarettes, including e-cigarettes. It is essential that the proposed rule be strengthened, since nicotine is highly addictive. Continue reading

Testimony of Dr. Anna E. Mazzucco on Ablatherm high-intensity focused ultrasound device

Prostate cancer is a very common cancer and all the current treatments have serious side effects that harm men’s quality of life. The question today is whether the Ablatherm high-intensity focused ultrasound device is safe and effective for the treatment of low-risk, localized prostate cancer. Most men diagnosed with localized, low-risk prostate cancer will not die from prostate cancer, but from something else. Continue reading

Comments urging FDA to provide higher standards and upclassify surgical mesh for POP and incontinence

On behalf of the National Center for Health Research, I am pleased to have the opportunity to express our views on the proposed order on the reclassification of certain surgical mesh devices and surgical instruments. Our nonprofit Center analyzes and reviews research on a range of treatment issues, and provides objective and understandable information to patients and providers. Continue reading

Statement of Dr. Diana Zuckerman, President of the National Center for Health Research, in support of the SWEET Act

Statement of Dr. Diana Zuckerman July 30, 2014 The National Center for Health Research strongly supports the SWEET Act introduced by Representative Rosa DeLauro (D-CT).  Today, sugary beverages represent the largest calorie source in an American teen’s diet — and … Continue reading

Statement of Laurén Doamekpor, Ph.D. at the Advisory Committee on Minority Health, Department of Health and Human Services

An important part of our work as a non-profit think tank is to assess scientific and medical data and provide objective health information to patients, providers and policy makers. Over the years, we see the same recurring problem. Racial and ethnic minorities are rarely included in sufficient numbers in clinical trials used as the basis of FDA approval of drugs and medical devices. And yet, these are the medical products that all patients — including millions of people of color — rely on Continue reading

Letter to Congressman Cooper strongly supporting the Research for All Act of 2014

June 5, 2014. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Research for All Act. It would require the FDA to develop policies to ensure that clinical trials for medical products granted expedited approval are sufficient in design and size to determine the safety and effectiveness for men and women, using subgroup analysis. Continue reading

Comments of the National Center for Health Research 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

Letter to FDA Commissioner Hamburg About Approving Cobas HPV Test Alone (Without Pap Smear) and FDA Response, April 2014

April 11, 2014. We are writing as members of the Patient, Consumer, and Public Health Coalition and other interested experts to express our grave concerns about the March 12, 2014 FDA meeting of the Microbiology Medical Devices Panel of the Medical Devices Advisory Committee. Under consideration was the premarket approval of a new indication for the Cobas HPV test, as a first-line primary screening tool for cervical cancer in women aged 25 and older.
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

Letter regarding Coalition Concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013

February 20, 2014. As members of the Patient, Consumer, and Public Health Coalition, which includes groups representing physicians, scientists, consumers, and patients, we are writing to express our concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 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

Testimony of Dr. Anna E. Mazzucco on Premarket Approval of Nucleus Hybrid L24 System Cochlear Implants

My name is Dr. Anna Mazzucco, and I thank you for the opportunity to speak today on behalf of the National Research Center for Women and Families. After completing my Ph.D. in Cell and Developmental Biology from Harvard Medical School, I conducted research at the NIH. Those are the perspectives I bring today. Continue reading

Comments on FDA Safety and Innovation Act Section 907 Report

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

Letter to FDA Regarding Advisory Committee Panel on Reclassification of CPR Devices

November 5, 2013. We are writing to express our strong concerns about the September 11, 2013 FDA meeting of the Advisory Committee for Circulatory System Devices. This Advisory Committee meeting discussed and made recommendations regarding the proposed down-classification of External Cardiac Compressor (ECC) devices. The panel members were asked to consider the FDA recommendation that ECC devices be reclassified from Class III (high risk) to Class II (moderate risk) with special controls. Continue reading

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

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

Coalition Letter to House Leaders in Opposition to Piecemeal Funding of FDA

October 4, 2013. We are writing as public health, patient, consumer, and scientific nonprofit organizations to oppose H.J. Res 77 and any other efforts to single out the Food and Drug Administration for funding.  Our organizations represent millions of patients, consumers, health professionals, and scientists who strongly support the work of the FDA and urge Congress to provide the level of appropriations the agency needs throughout FY 2014. Continue reading

Coalition Letter to Senator Harry Reid supporting Affordable Care Act and opposing repeal of excise tax on medical devices

September 26, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Patient Protection and Affordable Care Act (ACA) and oppose efforts to undermine this essential program that will benefit millions of Americans. In the upcoming negotiations over the budget and debt ceiling, we urge you to reject the repeal of the 2.3% excise tax on medical devices. 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

Letter to Senator Gillibrand in Support of the Military Justice Improvement Act

September 17, 2013. On behalf of the following nonprofit organizations from the Patient, Consumer, and Public Health coalition, we urge you to support Senator Kirsten Gillibrand’s (D-NY) Military Justice Improvement Act (S. 967) when it is offered as an amendment to the 2014 National Defense Authorization Act. 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

Letter to the CA Bureau of Electronic and Appliance Repair in support of improved flammability standards for furniture

September 3, 2013. As a nonprofit organization dedicated to improving public health, the National Research Center for Women & Families strongly supports the proposed revisions of California’s flammability standards for upholstered furniture and other products. 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 Docket No. FDA-2013-N-0461   As members of the Patient, Consumer, and Public Health Coalition, we urge you to finally follow the recommendations made by FDA classification panels[end The General and Plastic Surgery Device Classification Panel and the Physical … 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”

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

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

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

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

Letter to Congressman Markey in Support of VALID Act About Compounding Pharmacies

May 22, 2103. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2013. This bill would significantly strengthen FDA oversight of compounding pharmacies and help ensure patients get safe and effective life-saving medical products. Continue reading

Testimony of Dr. Jennifer Yttri on pedicle screw spinal systems

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”

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, 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

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

May 6, 2013. 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

Letter to Key U.S. Senators in Support of Funding for the Affordable Care Act

April 2, 2013. Like you, members of the Patient, Consumer, and Public Health Coalition are very supportive of the Patient Protection and Affordable Care Act (ACA). We were extremely disappointed that the Hatch-Klobuchar amendment (S. Amdt. 297 to S. Con. Res. 8) to repeal the 2.3% excise tax on medical devices was overwhelmingly supported. Thank you very much for your important vote against the amendment. Continue reading

Letter in support of the Delivering Antimicrobial Transparency in Animals Act

April 2, 2013. Letter to Representatives Henry Waxman and Louise Slaughter supporting the DATA act, which would require better reporting of how antibiotics are used in animals raised for food. This information is critical to understanding how antibiotic resistant bacteria in food animals affects human health. 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