National Center For Health Research

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 →

Exercise was shown to protect against the brain shrinking even if people with a family history of Alzheimer’s disease. Continue reading →

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 Dr. Diana Zuckerman, President National Center for Health Research Commissioner Hamburg has been a strong voice for public health and her resignation is a major loss at a dangerous time for the FDA. The 21st Century Cures … Continue reading →

The Wall Street Journal: FDA Commissioner Margaret Hamburg will step down at the end of March, and we point out this is a dangerous time for a change in leadership. Continue reading →

The New York Times: No one can say with certainty if the OtisKnee device caused Carla Muss-Jacobs’s problems, but in announcing an $80 million settlement of criminal and civil charges against OtisMed, United States Attorney Paul J. Fishman said patients “should be entitled to trust that the devices their doctors are using are safe, effective, tested and approved.” Continue reading →

Thanks to the Affordable Care Act, millions more Americans can now afford medical care that relies on devices like CT scans, cardiac implants or joint replacements. Our nonpartisan research center just released a report indicating that the device industry is thriving in the two years since the tax went into effect. Continue reading →

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Time, February 19, 2015. Time Magazine asks us why close ties to industry is a problem for a new FDA Commissioner Continue reading →

Patient advocates from across the country joined us for a day of training to learn more about the FDA process and how patients can have their voices heard. NCHR PCOR New Medical Products Patient Engagement EW Award Nov 2014

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 →

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LA Times, February 19, 2015. A commonly used medical scope may be too flawed to be safely sterilized. Is FDA to blame? Continue reading →

What small thing can you change that might make a difference in the lives of Alzheimer's and related dementias patients? Continue reading →

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 →

ABC15, February 25, 2015. Is Essure birth control risky? Continue reading →

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 →

21st Century Cures concerns. The American taxpayer is the customer for U.S. public health agencies, not private industry. Continue reading →

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CNN, March 3, 2015. Why did the FDA approve a medical device that can't be cleaned? Continue reading →

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

Preventing and Treating Alzheimer’s and Dementia

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

Statement of Dr. Zuckerman on FDA Commissioner Hamburg’s Resignation

The Hamburg Legacy at FDA: Accomplishments and Controversies

Knee Replacement Device Unapproved, but Used in Surgery

Letter to the Editor: “Keep the Medical Device Tax”

What do we have in common with Last Week Tonight’s John Oliver?

Candidate to Lead FDA Has Close Ties to Big Pharma

Patient Advocacy Workshop Report

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

The Medical Device Tax: Why We Need It and Who Is Trying to Take it Away

FDA knew of design flaw in scope linked to UCLA superbug

How Light Can Improve Life for People with Alzheimer’s Disease and Related Dementias

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

ABC15 Essure Investigation: Clinical trial participant for Essure birth control questions results

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

Summary of Comments from Members of the Patient, Consumer, and Public Health Coalition on 21st Century Cures Discussion Draft

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FDA: Manufacturer never had permission to sell device connected to superbug deaths