Category Archives: Press Releases

Consumer and Public Health Groups Support FDA Proposal to Ensure Accuracy of Lab-Developed Medical Tests

September 29, 2023

A coalition of consumer advocacy groups is welcoming a proposed rule released today by the Food and Drug Administration to regulate laboratory-developed tests (LDTs), a category of diagnostic tests developed and used in a single lab. LDTs are a subset of In Vitro Diagnostics (IVDs) which are FDA regulated, despite the fact that they have been regulated differently for decades. The proposal clarifies that LDTs are medical devices, meaning FDA will ensure they are safe and effective before they are sold to consumers. The tests have long been under “enforcement discretion,” meaning FDA has not enforced premarket approval and other requirements, but stakeholders and regulators alike have been calling for increased scrutiny of these tests for years.

The proposed regulation will take effect 60 days after a final rule is published and contemplates a phase-in over the subsequent four years. As these tests have become more complex and more important to patient care, ensuring their accuracy has become more crucial, according to the coalition, which includes the Center for Science in the Public Interest, the National Center for Health Research, Strathmore Health Strategy, and U.S. PIRG.

False-positive test results could lead patients to believe they have a serious medical condition that they do not have, and false-negative results may cause a patient’s life-threatening condition to be missed. Some tests have falsely diagnosed people with cancer or inaccurately provided results that lead directly to chemotherapy selection. Many of the tests have been found to be inaccurate, including some COVID-19 diagnostic tests, genetic non-invasive prenatal screening tests, and blood tests manufactured by the biotech company Theranos.

The group applauds many provisions of the proposed rule. These include:

  • Including Academic Medical Centers in the regulatory scheme. There is no reason that people treated or tested at one facility should be more at risk for inaccurate results than those tested at another facility. All tests should be evaluated based on the benefits and risks of the tests, not the building in which the test is run. The proposed rule notes that “[r]eview of the underlying science behind an [in vitro diagnostic] is based on what the IVD does and is in no way related to where the IVD is made.” The FDA requests additional information on this topic, but the coalition hopes the agency sticks to its guns.
  • Including tests for rare diseases in the regulatory scheme. Patients with rare diseases should be equally protected from inaccurate tests.
  • Registration and listing requirements for all tests, which exist for all other medical devices. This will allow FDA and the public to know which tests are available. Further, manufacturers are required to publish performance data on IVDs, which will provide much-needed transparency about the clinical and analytical validity of these tests, according to the coalition.

“This rule is a critical step forward for clinical medicine,” said Dr. Peter G. Lurie, President of Center for Science in the Public Interest and a former Associate Commissioner at the Food and Drug Administration where he worked on LDTs, including on a report demonstrating their potential dangers. “It will help ensure that when a patient receives a test, they can rely on the results to make essential decisions for their health. This rule will close a gaping hole in FDA’s current regulatory reach.”

In the absence of FDA oversight, LDTs have been regulated only by the Centers for Medicare and Medicaid Services, which does not require documentation that the test results accurately inform the diagnosis of patients, a concept known as “clinical validity.” CMS only requires laboratories to document the “analytical validity” of their tests, or their ability to reliably detect a biomarker.

Oversight under FDA would be much more comprehensive and would ensure that healthcare providers and patients can rely on results to make medical decisions, particularly the riskiest medical decisions, where inaccurate test results can cause harm to patients. A modern regulatory framework for LDTs will improve patient access to accurate tests and promote innovation in the diagnostic testing industry.

“We strongly support the decision by the FDA to do what is necessary to rectify a situation that has been so harmful to patients,” said Dr. Diana Zuckerman, President of the National Center for Health Research.  “We understand the need for a transitional period but urge the FDA to address problems with existing high-risk LDTs as quickly as possible. We welcome the opportunity to work with FDA and other interested parties to ensure that FDA has the resources it needs to robustly regulate LDTs so that patients can make informed decisions based on test results.”

This comprehensive approach will require resources, including both user fees and Congressional appropriations. The coalition will continue working with all stakeholders, including Congress and the Agency, to ensure that the agency is adequately resourced to fulfill this critical function.

For more information, contact Dr. Zuckerman at

Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants

Statement of Dr. Diana Zuckerman, President, National Center for Health Research on October 23 Regarding FDA Labeling Recommendations to Improve Patient Communication Draft Guidance

We thank the FDA for proposing a black box warning and a patient Informed Consent check list that provides specific, understandable information about the risks of breast implants.  The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with patient advocates and plastic surgeons.  The devil is in the details, so we look forward to working with the FDA to finalize these materials so that patients can make better informed decisions in the future than most women considering breast implants have been able to make. We will  keep working closely with the FDA, patients, and plastic surgeons to make that goal a reality.

For more information see FDA’s Draft Guidance here.

Dr. Diana Zuckerman’s Statement on FDA’s Request for Recall of Allergan Breast Implants and Expanders

Statement of Dr. Diana Zuckerman, President, National Center for Health Research on July 24 Announced Recall of Allergan Biocell Breast Implants and Expanders

“The FDA announced today that at its request, Allergan is implementing a worldwide recall of their Biocell textured breast implants and expanders.  This recall is an important step toward reducing the risk of a type of cancer of the immune system called Anaplastic Large Cell Lymphoma (ALCL) caused by breast implants.  Many other countries had already banned this type of Allergan textured breast implant, but the FDA had previously stated that such a ban was premature.  However, it was inevitable that either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so.  It is a little surprising that the FDA is taking credit for the recall, since most recalls of medical devices are described by the companies as voluntary.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma.  This recall will reduce that risk but it won’t eliminate it.”

For more information, see the FDA’s Press Release here.

Is FDA Doing Enough to Make Sure Sunscreens are Safe?

Is FDA Doing Enough to Make Sure Sunscreens are Safe?
National Center for Health Research Statement in Response to FDA Proposed Regulations
February 22, 2019

 The National Center for Health Research (NCHR) supports the FDA’s proposed new regulations for over-the-counter (OTC) sunscreens. The proposed updates on how products are labeled should make it easier for consumers to identify key product and ingredient information.  Expanding the requirements for broad spectrum protection is an important safeguard, because it provides better protection against damaging UVA radiation.

FDA has found two ingredients commonly used in sunscreens, zinc oxide and titanium dioxide, to be GRASE (Generally Recognized as Safe and Effective) and found two others, . PABA and trolamine salicylate to be not GRASE. The latter two were previously removed from sunscreens so that decision has no impact.  We are disappointed that the FDA has not recognized a widely used sunscreen ingredient, oxybenzone, as unsafe.  Oxybenzone has been found to disrupt hormones, and could increase the risk of endometriosis in women, and alters sperm in animals.  For those reasons, NCHR recommended in 2016 that this ingredient be banned from sunscreen products.

FDA’s proposed rule admits that “there is potential for toxicity associated with the transdermal absorption and systemic availability of oxybenzone.”  However, the proposed regulation states that “This new information about absorption and potential safety risks is inadequate, by itself, to support an affirmative conclusion that products containing the active ingredients at issue are not safe”.  NCHR strongly encourages FDA to require research as soon as possible if the companies plan to continue using it.

Sunscreens are proven to prevent sunburn and since sunburn increases the risk of skin cancer, sunscreens are assumed to also reduce the risk of skin cancer.  Since that link isn’t proven, the role of FDA in ensuring these products are safe is absolutely essential.  As we did in 2016, NCHR strongly urges that FDA expedite the adoption of the proposed rule’s safety and efficacy measures for sunscreens, and immediately require research on other sunscreen ingredients for which the agency has insufficient information.

If you have any questions, please contact Jack Mitchell at

Statement of Dr. Diana Zuckerman, President of the National Center for Health Research Regarding the New Study of 100,000 Women with Breast Implants

Dr. Diana Zuckerman, President of the NCHR: September 17, 2018.

In the largest study ever conducted of long-term health risks for patients with breast implants, researchers at The University of Texas MD Anderson Cancer Center have reported that women with silicone implants are more likely to be diagnosed with several rare diseases, autoimmune disorders, and other conditions.  These results are consistent with numerous previously published studies, but contradict the conclusions of studies funded by implant manufacturers or plastic surgery medical societies.

The study, published in the medical journal Annals of Surgery, is by researchers in MD Anderson’s Department of Plastic Surgery and is based on analyses of almost 100,000 patients with either saline or silicone implants. The information was derived from the FDA’s database dating back to 2005.  When the FDA approved silicone gel breast implants made by two manufacturers in 2006, the agency required that each of the manufacturers study at least 40,000 women for 10 years.  Those studies were started but never completed, making it impossible to determine the long-term risks of breast implants.  In the absence of such crucial studies, patients report that they were not warned about the risks when they decided to get breast implants.

We thank Mark W. Clemens, M.D., associate professor, Plastic Surgery, the senior investigator of this very important study.  The findings are consistent with what thousands of women with breast implants have reported in Facebook groups and other social media, and directly challenge the FDA’s claims that breast implants do not cause such diseases.  We urge the FDA to be more patient-centered and finally require independent studies be conducted of women before and after their breast implants are removed.  Many women have reported that their debilitating autoimmune symptoms decreased or disappeared after their breast implants were removed, but scientific data is needed to establish the rate of recovery.

Statement of National Center for Health Research Supporting A CDC Review to Save Women’s Lives

May 2, 2018

The National Center for Health Research strongly supports the announcement that the Centers for Disease Control and Prevention may conduct a review of the potential benefits of biopsies for women scheduled for hysterectomy or fibroid removal.  The review is essential because a recent article, published in the medical journal Obstetrics & Gynecology reports that the rate of unsuspected cancer is dangerously high in women undergoing hysterectomy.  When those women undergo surgery, particularly procedures involving a medical device called a power morcellator, the cancer can spread inside the woman’s abdomen, resulting in an early-stage cancer being upstaged to a much more dangerous metastatic (stage 4) cancer.  The risks are especially high for women ages 55 and older, reaching almost 10% for undiagnosed uterine cancer.

The study authors, from Yale Medical School and the Columbia University College of Physicians and Surgeons, studied more than 26,000 women who underwent hysterectomy or fibroid removal, and found that undetected cancers were much higher than previously estimated.  The implications are that the FDA’s warnings regarding the risk of power morcellation, which estimated one hidden cancer in every 352 women, are inadequate to provide informed consent for patients considering these surgical procedures.

We thank Dr. Redfield for his attention to this matter and urge the CDC leadership to move forward as soon as possible to develop guidelines pertaining to tissue biopsy methods that will identify women with gynecological cancer before the women undergo a surgical procedure to remove the uterus or fibroid.  Such testing could save thousands of women’s lives.

Diana Zuckerman, PhD
See our related letter to CDC Dirtector Dr. Robert Redfield here.

2018 Foremother and Health Policy Hero Awards Luncheon

National Center for Health Research, May 4, 2018

Friday May 4 is our Annual Awards luncheon at the Mayflower Hotel!

Every year, we take time off from our research and public education to thank women and men who have improved our lives.

The Foremother Lifetime Achievement Award recognizes women who expanded women’s horizons, improved our communities, and made remarkable contributions to our country.  We let them know what an honor it is to follow in their formidable footsteps.

We also recognize Health Policy Heroes. This award honors men and women (and in this case, boys and girls) who have changed the public debate and public policies in ways that help to improve the lives of adults and children nationwide.


Please join our wonderful Emcee Maureen Bunyan as we celebrate

the National Center for Health Research’s

2018 Foremothers Lifetime Achievement and Health Policy Heroes Awards Luncheon

Friday, May 4, 2018 at Noon
The Mayflower Hotel
1127 Connecticut Ave NW
Washington, DC 20036
We hope you will join us at the elegant Mayflower Hotel in Washington, D.C. as we celebrate these inspiring honorees.

Help us celebrate the amazing women who are our 2018 Foremother Lifetime Achievement honorees for careers that made all our lives better and broke down barriers for other women:

Dr. Rita Colwell is an extraordinary scientist whose work has successfully fought cholera and created safer water supplies around the world, saving lives while breaking down many barriers for women in science. She was the first woman to serve as Director of the National Science Foundation (NSF), presiding over a doubling of the NSF budget. She has won numerous other scientific awards over more than 40 years, including the National Medal of Science presented by then-President George W. Bush, and the Medal of Distinction from Columbia University. She previously served as the President of the American Association for the Advancement of Science (AAAS) and is a member of the prestigious National Academy of Sciences (NAS).

Lynn Povich is an award-winning journalist who began her career as a secretary at Newsweek magazine. She was one of 46 women who filed sex discrimination charges against the magazine in 1970, an experience that 40+ years later inspired her book THE GOOD GIRLS REVOLT, and the Amazon TV series that was soon followed by #MeToo. The law suit was groundbreaking, and she subsequently became the first woman appointed Senior Editor at Newsweek. Ms. Povich later became Editor-in-Chief of Working Woman magazine and then joined as East Coast Managing Editor. She also edited a book of columns by her father, famous sports writer Shirley Povich.  She serves on the Advisory Boards of the International Women’s Media Foundation, the Women’s Rights Division of Human Rights Watch, and the CUNY Graduate Center Foundation Board.

Our Health Policy Heroes are the students, teachers, and parents of Parkland, Florida; Washington, D.C. metro area; and across the country who are successfully fighting for effective policies to prevent gun violence. MSD High School student Kai Koerber and Parkland teacher Susan Rioux will be two of the heroes accepting the award on their behalf. Kai has been actively lobbying for better gun policies since the tragic shooting on February 14. Ms. Rioux is credited with having taught Parkland students how to find safety in violent situations, thus saving their lives during the February 14 shooting. She is now one of those helping the children cope with PTSD and fear in the aftermath and supporting their efforts to reduce gun violence. March for Our Lives Lodging, a group of mothers who organized free housing, meals, and other necessities for thousands of students and families traveling to D.C., will also be honored.


We hope you will take advantage of this great opportunity to meet these inspiring women, previous honorees, and many of D.C.’s other movers and shakers. Lunch is from noon to 1:30, preceded by a 11:30 champagne reception for honorees, patron guests, and sponsors only.

Prices below are valid through April 28.

Seats are limited and tickets are not available at the door.

Regular lunch tickets are available for a donation of $110 each. Patron Tickets ($175 per ticket) include a champagne reception with honorees at 11:30, priority seating, and a listing in the program. A Patron table for 10 is $1,750. Sponsorships are also available, from $1,800-$6,000.

The National Center for Health Research is the leading national organization dedicated to improving the health and safety of all adults and children. Donations for this event support our Cancer Prevention and Treatment Fund helpline.

To reserve a ticket, you may donate online here. Or, send a check payable to “NCHR,” to 1001 Connecticut Ave, Suite 1100, Washington, DC 20036.Be sure to indicate it is for the Awards Luncheon.

For more info, contact Alex Pew at or (202)223-4000.

Statement of Dr. Diana Zuckerman in Honor of Dr. Vivian Pinn

September 8, 2017

I am going to Charlottesville on September 13 to honor Dr. Vivian Pinn, our 2013 Foremother Awards honoree, as a major research facility at UVA’s School of Medicine is named in her honor.  Dr. Pinn received her medical degree from the University of Virginia in 1967, where she was the only woman and only African American in her graduating class. In 2005, she returned to UVA as the University’s first African-American woman commencement speaker, and UVA’s School of Medicine named one of its 4 student advisory colleges as the “Pinn College” in her honor. UVA’s School of Medicine honored her by establishing the “Vivian W. Pinn Distinguished Lecture Series in Health Disparities.”  And now she is the first African American to have a building named in her honor at UVA’s School of Medicine.

We honored Dr. Pinn with our Foremother Award in 2013.  As the first director of the National Institute of Health’s Office of Research on Women’s Health, Dr. Pinn has had many accomplishments.  But one of her most important was her support for the Women’s Health Initiative, which was the first study to determine that women’s  hormones do not need to be “replaced” after menopause, because combined hormone therapy actually increased the risk of heart attack, stroke, and breast cancer in postmenopausal women.  This study resulted in a drop in breast cancer among women for the first time, and has saved thousands of lives.

L to R: Former NIH Director Dr. Bernadine Healy, actor Pierce Brosnan, and
Dr. Vivian Pinn at a Congressional Briefing on Women’s Health Research in 1992.

Actress Elisabeth Rohm Urges You to Give Back and Join the Fight Against Cancer!

We are are proud to share our new public service announcement (PSA) featuring a devoted mother and talented actress, Elisabeth Rohm.

Click here to watch!


You’ve seen Elisabeth in Law & Order, The Last Ship, and with Jennifer Lawrence in Joy and American Hustle. And she has just joined the cast of CW’s Jane the Virgin.  We hope you will join Elisabeth Rohm by supporting The Cancer Prevention and Treatment Fund with a donation today.

We need your support now more than ever because of the very real threats from Congress. They want to reverse the ban on cancer-causing chemicals in our air, water, and our homes and neighborhoods.  And they are trying to lower safety standards on cancer medications.

Your donation makes a difference, because 98 cents of every dollar goes directly to programs and services, making us one of America’s Best Charities. The Cancer Prevention and Treatment Fund thanks you for your support on Giving Tuesday, and will continue to work tirelessly in the fight against cancer.

Thank you in advance for considering us worthy of your support!

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

Statement of Dr. Diana Zuckerman, President
Cancer Prevention and Treatment Fund
February 5, 2015

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 proposed legislation represents a frightening assault on the agency and the safety of medical products, and the FDA will need a very strong leader to protect its public health mission.

Many Members of Congress have been attacking the FDA nonstop for the last few years, criticizing FDA efforts to improve the safety of medical devices and to ensure the safety of pharmaceuticals, including those made by compounding pharmacies.  Congress lacks the scientific expertise make appropriate judgments about how or whether the FDA can safely speed up its already efficient approval process, so recent Congressional efforts to do so would undermine patient safeguards even more.   This has made the job of FDA Commissioner a thankless one, and at the same time made it more important than ever.