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September 9, 2016 – We support this draft guidance, which is a step in the right direction for protecting the public health. However, the guidance should be broadened to include all situations, regardless of whether the RLD has been withdrawn.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

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 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

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

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 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 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

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

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

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

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

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”

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

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

October 8, 2013 — 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

June 26, 2013 — 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

June 27, 2013 — 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

June 27, 2016 — 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

May 22, 2103 — 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