NCHR Testimony at the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee

Megan Polanin, Ph.D. March 14, 2017 Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a licensed clinical psychologist in Washington D.C. and a Senior Fellow at the National Center for Health Research. … Continue reading

NCHR Testimony at Public Meeting #5 of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

Stephanie Fox-Rawlings, Ph.D. January 25, 2017 Thank you for the opportunity to speak today. My name is Dr. Stephanie Fox-Rawlings from the National Center for Health Research. Our center analyzes scientific and medical data to provide objective health information to … Continue reading

NCHR testimony at 2016 FDA workshop on role of hospitals in modernizing evidence generation for device evaluation

December 5, 2016 – Hospitals are expected to play a key role in evidence generation and adverse event reporting for the National Evaluation System for Health Technology. While the collection and analysis of real-world data will be important for post-market surveillance of medical devices, the quality of information being collected and used for decision-making must be focused on making patient safety a priority. Continue reading

Call your U.S. Congressmen and Senators to let them know how you feel about health insurance!

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 Senators on the Innovation for Healthier Americans bills

We respectfully urge you to not advance the Senate’s Innovation for Healthier Americans bills or the House’s 21st Century Cures Act during the lame duck session of Congress. While the House version of the legislation provides additional funding for the National Institutes of Health (NIH), both the House and the Senate versions contain more controversial measures which would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA). Continue reading

NCHR Testimony at FDA Risk Communication Advisory Committee – Public Forum to Discuss Strategic Plan for Risk Communication and Health Literacy

November 7, 2016 – A major problem for FDA communication is how it has become increasingly promotional, rather than providing objective information about the products that the FDA regulates. Similarly, FDA needs to do a better job of preventing misleading information and inadequate explanations of risk in direct-to-consumer ads. Continue reading

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

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

September 13, 2016 – We strongly support the FDA’s regulation of cell and tissue products. The guidances are reasonable. Through regulation the FDA can protect patients and encourage innovation in the development of new treatments based on sound science. However, enforcement will be critical to stop untested and potentially harmful ‘therapies’. Continue reading

Center Supports FDA’s Guidance on Generic Drug Labeling Safety

September 9, 2016 – We support this draft guidance, which is a step in the right direction for protecting the public health. However, the guidance should be broadened to include all situations, regardless of whether the RLD has been withdrawn. Moreover, to truly ensure that generic drug labels are updated in a timely manner, the FDA needs to finalize the proposed rule, “Supplemental Applications Proposing Labeling Changes For Approved Drugs and Biological Products. 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 to FDA in preparation for the International Cooperation on Cosmetics Regulation Meeting

June 15, 2016 – Endocrine disrupting chemicals are present in cosmetics in the United States. Multiple types of endocrine disrupting chemicals are detected in almost all people due to their use of soaps, creams, and other cosmetics. These chemicals can harm the health of the people who use them. It is therefore essential for the FDA and the ICCR to consider the growing evidence for harm caused by endocrine disrupting chemicals in cosmetics. Continue reading

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

June 21, 2016 – 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

NCHR Testimony at 2016 FDA GDUFA Regulatory Science Meeting

May 20, 2016 – Generic drug research and policies have an enormous impact on the health and safety of millions of Americans and impact patient and prescriber confidence in generic drugs. We urge you to consider research that will improve drug quality through rigorous manufacturer inspections, increase patient safety through the communication of important drug information on generic drug labels, and promote the uptake of generic drugs where they have the potential to reduce cost and improve outcomes. 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

April 28, 2016 – 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

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

NCHR testimony at 2016 FDA workshop on hearing aid good manufacturing practices

April 21, 2016 – We support the need to improve access to high quality hearing aids and other medical devices for the aging population. However, we are very concerned that there is a heavy focus on increasing the adoption of hearing aids that is not balanced by strong explicit attention to safety or to devices that work well for the individuals buying them. We recommend stronger evidence explaining and supporting the safety and effectiveness of devices that impact hearing. Continue reading

NCHR testimony at 2016 FDA meeting on rociletinib

April 12, 2016 – We realize that there is currently an unmet need for a drug to treat patients whose NSCLC has become resistant to first line TKI therapies via the T790M mutation. However, this does not warrant the approval of yet another drug that will not significantly improve outcomes for these patients. Fortunately, there is hope on the horizon, because the preliminary results for osimertinib for the same patients appears to be much more effective with fewer serious side effects. 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 Flu Vaccine Testimony

March 4, 2016 – We applaud the FDA and CDC for changing the recommendations for children, to reflect the poor efficacy of the live attenuated influenza vaccine (nasal spray). We hope the FDA will continue to look carefully at whether the agency should rescind approval of the flu nasal spray, since it continues to show significantly lower efficacy than the standard flu shot towards certain flu strains.

There is another problem however, that I want to talk about today. The CDC has strongly encouraged patients to use antiviral medications if they get the flu. However, the evidence shows how little benefit Tamiflu offers, as well as significant risks for children. Continue reading

NCHR testimony at 2016 FDA workshop on point of care devices for monitoring warfarin therapy

March 18, 2016 – Point of care PT/INR devices represent an increasingly important part of the healthcare landscape. Transparent and robust design, performance studies, and clear data supporting safety and effectiveness are required to avoid device problems that could have wide-reaching consequences for patients and public health. The only way to gather such data is through a rigorous PMA process. Continue reading

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

February 26, 2016 – There are a number of devices currently on the market that pose safety risks to the public because they were inappropriately designated Class I. The upclassification of the surgical mesh instrumentation from class I to class II as well as the new classification of centrifuge apheresis devices as class II are both moves towards increasing patient safety. The special controls suggested by the FDA should be carefully evaluated to determine if they are adequate to protect patients from undue harm. Continue reading

NCHR testimony at 2016 FDA meeting on TOPAS treatment for fecal incontinence

February 25, 2016 – The lack of a comparison group or data for substantial groups of women most likely to suffer from fecal incontinence makes it impossible to determine if this device would benefit them. A control group is needed to determine if the device is effective for anyone, and if it is, it should be approved only for the types of women studied, not for the types of women who were intentionally excluded.

We encourage you to recommend that these studies be conducted before a decision is made about whether or not to approve this device. Continue reading

NCHR testimony at 2016 FDA meeting on leadless cardiac pacemakers

February 18, 2016 – Leadless pacemakers have the potential to improve the care of patients with various cardiac rhythm disorders. However, this will require an understanding of how acute adverse events compare and contrast with those of traditional pacemakers. I encourage you to urge the FDA to require comprehensive data regarding the intermediate and long-term safety and effectiveness of leadless pacemakers. Post approval studies should clearly assess these diverse factors. They should provide context regarding the entire spectrum of safety and effectiveness in a way that enables physicians to make sound decisions, and that allows patients to fully and clearly understand the risks and benefits of this new technology. Continue reading

NCHR testimony at 2016 FDA meeting on vortioxetine treatment of cognitive dysfunction in major depressive disorder

February 3, 2016 – I urge you to conclude that there is insufficient data to claim that vortioxetine is effective in providing a meaningful improvement in cognitive dysfunction associated with MDD. Thank you for the opportunity to speak today and for consideration of our views. 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 the Patient, Consumer, and Public Health Coalition on the Proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine

It is important that the statement concisely describe the benefits and risks associated with the vaccine. But it is equally important that the statement provide all the essential information about the vaccine. 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 14, 2015 FDA Advisory Committee Meeting on IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT)

December 14, 2015 – The very small chance of any potential benefit and the high cost of preventing one cardiovascular event lead us to conclude that ezetimibe is not the cure most patients desire. Continue reading

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

December 10, 2015 – We strongly urge the FDA to require labeling that states that codeine is contraindicated for cough and pain in children less than 12 years of age.

We also strongly urge the FDA to remove codeine from the OTC monograph. To be marketed as an OTC drug, a drug must be generally recognized as safe and effective. Nearly half of the states already recognize that codeine is not safe enough for over-the-counter status. The children in the other states deserve the same protection by
removing codeine from the OTC monograph.

Lastly, we strongly urge the FDA to require prescription codeine labeling to state that codeine is contraindicated in women who are breastfeeding. Codeine is currently one of the most commonly prescribed opioids for women after cesarean section births. Many providers appear to be unaware of the risks of prescribing codeine to these
women. At least one infant has died after receiving a lethal dose of opioid from his
mother’s breast milk. Many other safer pain relief options are available. Continue reading

Statement of Dr. Tracy Rupp at the November 24, 2015 FDA Advisory Committee Meeting on Drisapersen for Duchenne Muscular Dystrophy

November 24, 2015 – Drisapersen is a drug being studied for Duchenne muscular dystrophy. However, a recent large, phase 3 clinical trial did not find that it was effective at helping patients walk further. 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

November 6, 2016 – 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

Comments 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

Dr. Diana Zuckerman at FDA Meeting on Essure Contraceptive, September 24, 2015

September 24, 2015 – If the product is to be on the market, who should do the studies to accurately determine the short-term and long-term effectiveness and side effects? The company’s track record and response to the women’s reported complications is not acceptable. Any additional research should be conducted independently of the company so that patients can have confidence in its accuracy. 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)

July 13, 2015 – 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. Nicholas Jury Before the FDA Advisory Committee on Cholesterol Drug Alirocumab

June 9, 2015 – We are asking you to reject approval of this drug for women and people of color until and unless subgroup analyses indicate the benefits outweigh the risks for those populations.

It is long past time that companies that want the FDA to approve their drugs for all adults do a better job of proving they are safe and effective for all adults. Continue reading

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

June 2015 – 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

Comments 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

Testimony for FDA Advisory Committee: Gastroenterology and Urology Devices Panel

May 14, 2015 – We enthusiastically support increased transparency with patients during the informed consent process about the risks of infection transmission during the ERCP procedure. Patients are entitled to full disclosure of the potential risks of any procedure or treatment they receive.

In addition, patient notification measures should be in place at all healthcare facilities that perform ERCP procedures. Rapid response to potential outbreaks relies on the ability of healthcare facilities to track their duodenoscopes and inform the relevant patients at the first sign of danger.

Lastly, the FDA report highlighted past deviation from manufacturer’s instructions and use of cleaning accessories, which are not cleared by the FDA for this purpose. These deviations were not reviewed by the FDA as factors which may contribute to contamination. Since these deviations seemed to be quite common, they deserve further investigation. We ask that the panel consider requiring that warning labels should be placed on duodenoscope packaging AND in areas where they are cleaned. These warnings would remind decontamination staff that duodenoscopes should be re-processed according to the manufacturer’s instructions. 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”

January 8, 2015 – 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 the proposed order on Reclassification of Iontophoresis Devices Intended for Any Other Purposes

December 22, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on the proposed order on Reclassification of Iontophoresis Devices … 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