NCHR says YES to the Medical Device Guardians Act

NCHR supports this bill because there is clear scientific evidence that the vast majority of adverse events from medical products are not reported by physicians, and the percentage may be especially low for devices. “Since most devices are allowed to be without any scientific evidence of safety,” Zuckerman points out, “requiring adverse events to be reported by physicians is especially important.” Continue reading

Statement of Dr Diana Zuckerman, President of the National Center for Health Research – FDA’s Approval of Eteplirsen for Duchenne’s Muscular Dystrophy

The internal documents released by the FDA today show that the FDA scientists in charge of reviewing the drug concluded that it should not be approved. They expressed concern that Dr. Janet Woodcock had decided FDA should approve the drug before she looked at the scientific evidence that the FDA had requested. Those scientists then asked FDA Commissioner Califf to reverse Dr. Woodcock’s decision, but he denied that request. Continue reading

NCHR Testimony at the FDA’s Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products

Testimony of Dr. Stephanie Fox-Rawlings FDA’s Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products     September 13, 2016 Thank you for the opportunity to speak today. My name is … Continue reading

Congress Shouldn’t Pass The 21st Century Cures Act In A Summer Rush

The full Senate may in the next few days consider companion legislation to the 21st Century Cures Act that passed the House last year. The legislation—currently 19 separate bills—makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices. The legislation, while containing some useful measures, is flawed. Instead of hastily agreeing to it, Congress should postpone consideration until 2017 and attach the best of the 19 bills (see below) to must-pass legislation on FDA funding through industry user fees. Continue reading

NCHR Testimony at Public Meeting #3 of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

NCHR is not convinced that strategies to encourage the private sector to solve the problem of new antibiotic development make sense, because there is an inherent conflict between a company’s investment to develop new antibiotics for targeted populations and the public health need to prevent wide-spread use of those drugs. Continue reading

NCHR Comments to FDA on Draft Guidance for Generic Abuse-Deterrent Opioids

We agree with many of the recommendations in the guidance and strongly urge the FDA to consider our recommendations regarding the use of the term “abuse-deterrent,” the development of guidance addressing additional abuse-deterrent technologies, the scrutiny applied to Tier 1 studies, and the enforcement of post-marketing study requirements for reference products. Continue reading

Letter to House Members opposing language added to the appropriations bill that lowers the FDA’s safety and efficacy standards for drugs and devices

April 15, 2016   The Honorable XXX YYY U.S. House of Representatives Washington, DC 20515   Dear Representative YYY,   The National Center for Health Research strongly opposes language added at the last minute to the House Agriculture, Rural Development, Food and … Continue reading

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 Supports Proposed FDA Regulation of Sunscreens

March 25, 2016. NCHR strongly supports the safety and effectiveness clinical and nonclinical testing requirements to obtain generally recognized as safe and effective (GRASE) status, as they are delineated in the draft guidance. The proposed testing requirements for new sunscreen chemicals will assure our country’s most vulnerable that the products will protect them from skin cancer and not cause unintended harm. 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

Comments of members of the Patient, Consumer, and Public Health Coalition on “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications”

As members of the Patient, Consumer, and Public Health Coalition, we support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling. 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

What would impact of 21st Century Cures Act be on your healthcare costs and the lives of Alzheimer’s patients?

A controversial proposed new health law would have had a terrible impact on the lives of Alzheimer’s patients and their families, who would have spent billions on medications that don’t work and can cause cancer. 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

Letter to the U.S. Consumer Product Safety Commission regarding supplemental mattresses

October 13, 2015. The National Center for Health Research supports Keeping Babies Safe’s (KBS) petition that requests a ban on supplemental mattresses for play yards with non-rigid sides. These mattresses present an unreasonable risk of injury or death (suffocation) to infants and toddlers. 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

Letter to the U.S. Consumer Product Safety Commission regarding Corded Window Coverings

June 1, 2015. We submit these comments in strong support of the U.S. Consumer Product Safety Commission’s (CPSC) development of a mandatory standard that prohibits hazardous, accessible window covering cords. A mandatory standard is needed because the current voluntary standard, which relies on warnings, has not significantly reduced the death rate Continue reading

Let your U.S. Senators know how you feel about unsafe medical products!

The House of Representatives passed a bill called 21st Century Cures that would lower the standards for approving drugs and medical devices. They say it will benefit patients, but it was written primarily by pharmaceutical and device companies and reflects their desire to get medical products approved on the basis of skimpier evidence than the law currently requires. Continue reading

Letter to the Dietary Guidelines for Americans Committee (DGAC) regarding the Dietary Guidelines for Americans (DGA)

May 8, 2015. The National Center for Health Research presents these comments on the expert report prepared for the eighth edition of the Dietary Guidelines for Americans (DGA) by the Dietary Guidelines for Americans Committee (DGAC). Overall, we strongly support the conclusions and policy recommendations in the report. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from any agricultural or food manufacturing industries, and have no conflicts of interest in making our recommendations. 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

Letter to Congresswoman Rosa DeLauro Supporting “Helping Effective Antibiotics to Last” (HEAL) Act

February 12, 2015. The Centers for Disease Control and Prevention (CDC) points out that two major actions are urgently needed to address the threat posed by antibiotic resistance are: 1) stop the misuse of existing antibiotics, and 2) develop effective new antibiotics. HEAL is the first bill to focus on both these necessary actions. 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

Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers

December 15, 2014. We strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. The Cardiovascular Devices Panel stated on March 9, 1979 that these devices should be classified into Class III because the device “provided temporary life-support and that certain kinds of failures could cause this device to emit inappropriate electrical signals, which could cause cardiac irregularities and death.” 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

Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices

The US Food and Drug Administration (FDA) approves about 400 implanted medical devices each year through an abbreviated process called the 510(k) process, which only rarely requires clinical trials (studies of patients). Continue reading

Comments on Internet/Social Media Platforms Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

October 29, 2014. We welcome the opportunity to provide feedback on this draft guidance regarding use of internet and social media platforms for communicating about medical products. Patients and consumers increasingly rely on social media and the internet as sources of health and medical information that influence their decisions to seek medical care. 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

Comments on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications

October 14, 2014. We oppose the draft guidance as written and strongly urge the FDA to rewrite it. The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments. When it is more specific, it promotes the use of surrogate endpoints and the risk tolerance of a small number of patients whose views come to the FDA’s attention. 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

Chantix Citizen Petition

October 8, 2014. Five leading nonprofit consumer, research and medical organizations identified below petition the Food and Drug Administration (FDA) pursuant to the Food, Drug, and Cosmetic Act 21 USC 352, 505(o)(4), and 21 CFR 10.30 to take action to improve the safety information included in the label for CHANTIX® (varenicline) tablets , a smoking cessation aid approved under NDA 021-928. 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