NCHR testimony at 2016 FDA workshop on drugs and biological products used during lactation

More clinical studies are desperately needed to determine the safety of drugs in lactating mothers. When these studies are in the planning stages, be cognizant of enrolling mothers that represent a wide diversity of races, ethnicities, and–when appropriate for the drug–ages. Continue reading

Eteplirsen for Duchenne Muscular Dystrophy, Dr. Laura Gottschalk’s Statement at FDA, April 25, 2016

U.S. law requires evidence of safety and effectiveness. The burden of proof lies with Sarepta. If this drug actually works, then Sarepta has failed itself, the patients, and their families, by not conducting a better study that could provide convincing evidence showing that it works. Continue reading

Statement of Dr. Zuckerman on Bayer’s adverse reports on Essure

April 19, 2016. Dr. Zuckerman explains the attempt by Bayer to make the adverse reports regarding Essure seem less credible. By counting physicians and other health professionals as “other,” Bayer assumed correctly that the FDA would take the reports less seriously. And, the same thing would happen when the FDA reported those adverse events. Continue reading

NCHR testimony at 2016 FDA meeting on the classification of urogynecologic surgical mesh instrumentation and automated, blood cell and plasma separators

Testimony of Dr. Laura Gottschalk FDA Advisory Committee Meeting on Reclassification of Urogynecologic Surgical Mesh Instrumentation and Classification of Separator, automated, blood cell and plasma, therapeutic February, 26, 2016 Thank you for the opportunity to speak today. My name is … Continue reading

NCHR Testimony at 2016 FDA meeting on Allergy Products

January 21, 2016. Allergies can be a life-and-death situation. Approximately 100 people die each year from anaphylaxis due to food allergies. Treatment options for food allergies could save lives, significantly improve quality of life for many families, and reduce the number of severe reactions from occurring. The increase in food allergy prevalence is an important public health problem. We must require that clinical trials study all of the necessary variables to help families make informed treatment choices. Continue reading

Statement of Dr. Tracy Rupp at the December 10, 2015 FDA Advisory Committee Meeting on Codeine Use in Children

Thank you for the opportunity to speak today. My name is Dr. Tracy Rupp: I was previously a clinical pharmacist and pediatric nutritionist at Duke University Medical Center and am now the Director of Public Health Policy Initiatives at the National Center for Health Research. Our research … Continue reading

Statement of Dr. Tracy Rupp at the November 6, 2015 FDA Advisory Committee Meeting on Sugammadex

Since sugammadex has the ability to quickly reverse the paralysis induced by neuromuscular blockers like rocuronium, it represents an innovative new option to improve surgical recovery. However, as with every new drug, we need to be certain the benefits outweigh the harms. Continue reading

Statement of Dr. Tracy Rupp at the October 5, 2015 FDA Meeting on Risk Evaluation and Mitigation Strategies (REMS)

October 5, 2015. Our Center strongly supports research and programs to improve drug safety. We remember when REMS were first proposed in legislation, the reason was to enable FDA to approve drugs with serious risks by providing a mechanism to mitigate those risks. Continue reading

Statement of Dr. Christina Silcox at the July 13, 2015 FDA Public Meeting on the Reauthorization of the Medical Device User Fee Act (MDUFA)

MDUFA should protect the public health by improving the safety and efficacy of all medical products, whether PMA or 510(k). That requires higher user fees, performance standards that focus on the quality of the review and not just the speed, and reviews that provide patients, consumers, and healthcare providers with information about how well the product works compared to other similar products on the market. Continue reading

Testimony of Dr. Christina Silcox Before the FDA Advisory Panel on Flibanserin

The Center strongly supports research to advance understanding of, and solutions to, women’s lack of sexual desire. We understand that it is a real and distressing problem for many women. We have followed the regulatory history of flibanserin. Based on our analysis of the study results available today, we conclude that the benefits of this drug do not outweigh the risks. We ask the Advisory Committee to vote against approval of this drug. Continue reading

Testimony on Generic Drug Labeling before FDA by Dr. Anna E. Mazzucco

March 27, 2015. The current situation creates a terrible double standard, making patient with generic drugs second class citizens. And, when brand name drug manufacturers leave the market after generics become available, nobody is held responsible for updating the label. This is completely unacceptable. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan on the Dietary Guidelines Advisory Committee’s report

March 24, 2015. We strongly agree with the Dietary Guidelines Advisory Committee’s report of a healthy diet as one that is: higher in fruits, vegetables, whole grains, low-fat dairy, seafood, legumes, and nuts; lower in red and processed meats; low in sugar-sweetened foods and drinks; and lower in sodium. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee discussing a new drug application for Asthma

March 19, 2015. Long-acting beta-agonists have a history of serious adverse events in asthma patients including a four-fold increase in asthma-related death. So, let’s start with the assumption that we don’t want a new LABA on the market unless we have good evidence about safety and efficacy. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA committee on Dermatologic and Ophthalmic Drugs on clinical trials for Atopic Dermatitis in pediatric patients

March 9, 2015. Atopic dermatitis affects a very young patient population, so it critical to have safety information for all age groups to prevent dangerous off label use. This is a vulnerable patient population, and the benefits for the treatment must be proven to outweigh the risks. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA committee on Vaccines and Related Biological Products

March 4, 2015. An effective flu vaccine is critical for public health. Antiviral medications have very limited efficacy, so for many people the flu vaccine is the best line of defense to protect against infection. The CDC’s latest report calculated a 19% vaccine efficacy this year. That is simply not good enough. More importantly, this is not just one bad year. Four of the last 10 years the vaccine has been less than 40% effective. Continue reading

Testimony of Dr. Christina Silcox Before the FDA Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee on the Superion InterSpinous Spacer Device

February 20, 2015.

Lumbar spinal stenosis is the most common indication for spine surgery in patients older than 65, and its prevalence in the United States is expected to rise 59% by the year 2025. That means that the FDA’s decision about whether or not to approve this device will affect the lives and health of many men and women. The Superion IDE trial shows that the Superion ISS Device is non-inferior to the X-Stop device. But does that mean it should be approved? Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA committee on Joint Dermatologic and Ophthalmic Drugs Advisory Committee/Ophthalmic Devices Panel

February 24, 2015. It is clear that patients suffering from Keratoconus or Corneal ectasia need treatment options. The risk-benefit analysis may support approval of corneal cross-linking for those patients, however we are very concerned about the data presented here showing limited efficacy. We are also extreemly concerned about off-label use of this risky technology. The incidence of adverse events from the cross-linking procedure is very high, so this procedure should NOT be used except for those diseases/conditions. Continue reading

Testimony of Dr. Anna Mazzucco before the FDA on “Framework for Regulatory Oversight of Laboratory Developed Tests”

Our Center has frequently urged the FDA to improve their oversight of medical devices. Despite past criticisms, we believe it is essential that FDA have the authority to regulate laboratory-developed tests in order to stimulate even better science, and help ensure that patients receive the full benefit of our growing scientific knowledge. Continue reading

Statement of Anna E. Mazzucco, Ph.D. Before the Food and Drug Administration on Updating the “Redbook”

December 9, 2014. We enthusiastically welcome further action from the FDA on all substances over which the Center for Food Safety and Applied Nutrition has authority. While the FDA has taken steps to address safety concerns regarding some substances, we strongly urge the agency to use its full authority to ensure the safety of all food-related and consumer products. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan Before the FDA Advisory Committee on Anti-Infective Drugs

December 4, 2014. Antibiotic resistance and the inability to treat common infections is an increasingly urgent public health crisis which affects everyone, especially some of the most vulnerable in our society. Finding treatment options for unmet populations is urgently important but ineffective antibiotics lead to an increase in antibiotic resistance. Continue reading

Statement of Diana Zuckerman, PhD at FDA Joint Public Advisory Committee Meeting on Chantix

October 16, 2014. We strongly urge you to urge the FDA to keep the black box warning to protect patients and that you strengthen rather than weaken that boxed warning. And, since the meta analyses are fatally flawed, as I and others have pointed out, the FDA should delete the misleading meta-analyses info from the Chantix label. Continue reading

Testimony of Dr. Christina Silcox Before the FDA Advisory Panel on the Device Classification of More-than-Minimally Manipulated (MMM) Allograft Heart Valves

Oct. 9, 2014. We support the FDA’s recommendation that More-than-Minimally Manipulated (MMM) Allograft Heart Valves be classified as Class 3 devices and therefore subject to the premarket approval process. All other types of heart valves under the oversight of the Center for Devices and Radiological Health at the FDA are classified as class 3. There is no reason that these heart valves should be an exception. Continue reading

Testimony of Dr. Christina Silcox Before the FDA Advisory Panel on the WATCHMAN™ Left Atrial Appendage Closure Device

Oct. 8, 2014. We all know that AF patients are at high risk of ischemic stroke. Warfarin is well-established as an effective treatment, and other new therapies provide safe and effective alternatives. Any new treatment should show clear evidence that the benefits outweigh the risks.

Like many of you, we are skeptical that the Watchman device achieves that goal. The PREVAIL trial shows that the Watchman device is inferior to warfarin for 2 of the 3 primary endpoints. Ischemic strokes and systemic embolisms occurred at higher rates in the Watchman group compared to the control group. Continue reading

Presentation at the 2014 Congressional Black Caucus Fall Health Braintrust

On September 26, 2014, Senior Fellow Laurén A. Doamekpor, Ph.D., M.P.H, gave a presentation titled “Racial/Ethnic Diversity in Clinical Trials: Implications for Black Women’s Health” at the 2014 Congressional Black Caucus Fall Health Braintrust. To view the PDF of her powerpoint presentation, … Continue reading

Testimony before the Joint Meeting for Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

September 17, 2014. From 2010 to 2013, the number of patients receiving testosterone prescriptions increased from 1.3 million to 2.3 million. That means a large and growing number of patients may be at-risk for major adverse events due to TRT. At the same time, it is not clear what percentage of the men taking TRT actually need it for medical reasons. 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

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

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

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

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

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

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

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

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

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

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