Changing Laws and Policies

We Comment to FDA on the Draft Guidance Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act September 12, 2023: Noncompliance with required post-market studies (PMRs) is a serious problem that undermines FDA’s authority and the public trust in FDA decision-making. We support the process described in the guidance for applicants to correct circumstances that led to non-compliance with the agreed upon PMRs; however, we urge that the description of the actions taken by the applicant to address these issues be more explicit and less subjective. 
NCHR Comments on FDA’s Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising June 26, 2023: In our public comment, NCHR supports the FDA’s survey on evaluating patients’ understanding of quantitative information provided in prescription drug advertising. We strongly recommend adding an assessment of comprehension for factors such as relative risk, absolute risk, relative benefit, and absolute benefit of drugs. We urge the FDA to include a diverse demographic of participants in the one-on-one interview informing the survey and provide details about the number of interviews OPDP plans to conduct.
NCHR Comments on USPSTF Draft Recommendation on Breast Cancer Screening June 6, 2023: The U.S. Preventive Services Task force has changed its recommendations for mammography to start at age 40 instead of 50. However, they still recommend mammograms every 2 years instead of every year. We point out that there are racial differences in cancer risk and that mammography guidelines should reflect those racial differences. One size does not fit all.
Patient, Consumer, and Public Health Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings July 7, 2023: The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
Meeting of Patient, Consumer, and Public Health Coalition with Commissioner Califf and Key FDA Officials March 1, 2023: As a leader of the Patient, Consumer, and Public Health Coalition, we scheduled a meeting at the FDA with Commissioner Califf and other key FDA officials to discuss accelerated approval, lab developed diagnostic tests, and improvements to FDA Advisory Committees.
Joint Letter from from Cancer Groups and Patient-Centered Nonprofits about VALID Act in Omnibus December 16, 2022: Letter to Congress to include an improved VALID Act in the Omnibus bill. As described in the current VALID provisions in the bill, only the highest risk devices would be required to provide clear evidence of accuracy, and the definition of high risk is unclear and based on the FDA’s track record is likely to exclude many tests that could cause irreparable harm, such as genetic tests that are used to inform people that they are at very high risk of breast cancer, ovarian cancer, stomach cancer, and other very serious diseases.
Comment of the National Center for Health Research Submitted to the EPA on the Designation of PFOA and PFOS as CERCLA Hazardous Substances, October 6, 2022 October 6, 2022: In our public comment to the EPA, the National Center for Health Research agrees with EPA’s proposed designation of PFOA and PFOS as CERCLA hazardous substances. Holding companies accountable for these toxic chemicals, and other PFAS chemicals, will improve human health.
Joint Letter to Support FDA Proposed Rule Reducing Nicotine Levels in Cigarettes September 12, 2022. The undersigned public health, medical and professional organizations write in strong support of your recent announcement that FDA will issue a proposed rule to reduce the nicotine level in cigarettes to non-addictive or minimally addictive levels. Such a standard would generate massive public health benefits, preventing millions of young people from smoking and dramatically reducing the number of people who die from tobacco-caused diseases. We urge you to move forward with this proposal as quickly as possible.
Draft Senate Contact Letter for Patients Supporting User Fee legislation With Policy Riders August 18, 2022: I am writing on behalf of myself as a cancer [patient/advocate] and constituent of the state of [Add State] to convey my strong opposition to efforts to strip user fee legislation of important public health protections in favor of a “clean” user fee bill.
NCHR Comments on the MDUFA V Commitment Letter April 21, 2022: NCHR would like to express our substantial concerns with the overall process as well as the shortcomings of the Commitment letter.
Joint Letter Opposing Efforts to Weaken FDA’s Authority over Tobacco Products July 7, 2020. NCHR joins nonprofits to urge House to oppose any efforts to weaken FDA’s authority over cigars or any other tobacco products.
NCHR Comments on Public Access to Federally Funded Research May 6, 2020. In this comment, we will focus on two issues: 1) Access to peer-reviewed scholarly publications and 2) Access to data for analysis.
The Breast Implant Working Group’s Breast Implant Black Box Warning and Patient Checklist NCHR proposed a patient checklist to encourage informed consent before getting breast implants. The checklist would be signed by patients and surgeons.
NCHR Letter to Senators Regarding the Impact of the Government Shutdown on Patient Safety NCHR authored a letter to senators regarding the effects of the government shutdown on the FDA and, therefore, patient safety.
Comments on Tobacco Control Efforts in the U.S.-United Kingdom Trade Agreement We signed on to a letter with twenty either other organizations to comment on the US-UK Trade Agreement in regard to the tobacco industry action.
Letter from Nonprofits to DC Mayor and Other Officials About Dangers of Artificial Turf and Playgrounds July 10, 2018. DC Nonprofits write to DC Officials about the dangers of artificial turf and playgrounds. Both environmental and health concerns are discussed, and officials are advised to stop the usage of this kind of turf around children.
Letter to Board of Education of Montgomery County on Artificial Turf Fields and Playgrounds April 23, 2018. Many of the synthetic playground materials being used contain carcinogens, and when children are exposed to those carcinogens day after day, week after week, and year after year, they increase the chances of our children developing cancer, either now or as they get older. That should be adequate reason to not install them in Montgomery County.
Comments by Diana Zuckerman, Ph.D. on the U.S. Consumer Product Safety Commission Agenda and Priorities for FY2019/2020 April 11, 2018. Endocrine disruptors and chemicals in common consumer products that do not stay bound to those products get into the air and dust and thus into our bodies. These chemicals tend to pose greater risks to fetuses and children, and there are large gaps in our knowledge about the chemicals in the products on the market.
NCHR Letter to the Senate on Right To Try March 23, 2018. We are writing to urge you to vote against the Right to Try bill that recently passed the House of Representatives (HR 5247) despite strong opposition from the Democratic leadership. Although HR 5247 includes some potentially useful requirements that the results of patients’ access to experimental drugs be made available to the FDA, so that they will be aware of serious harm that could be caused, there is no enforcement mechanism to make sure that information is made available.
Right To Try Fact Sheet The Right to Try bill creates a program that is not as good as the existing FDA “Expanded Access” program, which has approved 99% of requests they received.
Statement on Failure of “Right to Try” Bill March 13, 2018. We thank Congress for rejecting the dangerous and misnamed “Right to Try” bill yesterday. The bill would harm more patients than it would help.
NCHR Letter to Maryland on State Funding for Artificial Turf and Playgrounds March 5, 2018. The State of Maryland has many spending priorities and should not be spending millions of dollars for artificial turf fields and playgrounds that can exacerbate our children’s health problems now, and potentially cause them to develop cancer in the years to come. Let’s instead invest in safe, natural playing fields, unless any synthetic alternatives are proven in unbiased research to be as safe and as cost-effective as grass for fields and engineered wood fiber for playgrounds.
NCHR Letter to House Energy and Commerce Committee on Right To Try Legislation February 22, 2018. Some terminally ill patients are willing to take big risks to have a chance to live longer, and if they want the “right to try” experimental treatments that are undergoing clinical trials, they should be able to do so as long as they are well informed of the risks as well as the possible benefits.
Testimony of Dr. Diana Zuckerman Before the Maryland House of Delegates Appropriations Committee on the Health Risks of Artificial Turf February 8, 2018. It is essential that the State of Maryland stop paying for artificial turf fields and playgrounds that can clearly exacerbate our children’s existing health problems and cause new  health problems. Let’s instead invest in safe, natural playing fields, unless any artificial alternatives are proven to be safer, more effective, and as cost-effective as grass.
Health Insurance: It’s Open Enrollment Season – Now What? Open enrollment is the time every fall when you have the chance to either stick with your old health insurance plan or pick a new one. This year, the period is from November 1st to December 15th.
NCHR Statement on Right To Try Legislation before the House Energy and Commerce Subcommittee on Health October 3, 2017. We strongly urge this Committee to reject the Right To Try legislation that is currently under consideration, because it would undermine the successful FDA compassionate waiver program already in place to enable patients to have access to experimental drugs for free or at cost.
NCHR Comments to CPSC on the Organohalogen Flame Retardant Petition September 14, 2017. In order to keep our children safe, it is essential to regulate OFRs collectively as a class unless and until there is scientific evidence that one or more particular OFRs is proven to be safe, and then treat that specific OFR differently.
Letter from NCHR about Dangerous Playgrounds and Athletic Fields to the Mayor and City Council of Washington, DC July 19, 2017. We wrote a letter to DC Mayor Bowser expressing our concern about artificial turf and the harm it can do to children.
CPTF Response to Senate Health bill The Senate’s revised health bill was revealed on July 13, 2017. Unfortunately, the revised Better Care Reconciliation Act of 2017 will result in much worse, not better, health care for Americans than our current healthcare program.
Statement of Cancer Prevention and Treatment Fund in Response to CBO Score for Senate Health bill This is no joke. The Congressional Budget Office’s report only makes it clearer that the Senate health bill will not result in better health care for Americans.
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).
What would impact of 21st Century Cures Act be on cancer and your healthcare costs? A controversial proposed new health law would have had a terrible impact on the lives of Alzheimer’s patients, who would have been more likely to develop skin cancer and at the same time had no benefit to their memory.
Statement of Dr Diana Zuckerman: regarding the introduction of The Prescription Drug Affordability Act of 2015 September 10, 2015. We applaud Sen. Sanders and Sen. Cummings’ bill.
August 24, 2015 Letter to the FDA about ads for “natural” tobacco As a member of the Campaign for Tobacco-Free Kids, the Cancer Prevention and Treatment Fund recently signed on to a letter to the FDA regarding advertising of “natural” tobacco.
Letter to Secretary of Department of Health regarding application of new Tobacco Control Act January 29, 2015 The Honorable Sylvia M. Burwell Secretary Department of Health and Human Services 200 Independence Avenue, SW Washington, D.C. 20201   Dear Secretary Burwell: We are writing to affirm the public health importance of applying the new product provisions of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) to products … Continue reading Letter to Secretary of Department of Health regarding application of new Tobacco Control Act
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.
Sign on letter to Senator Nelson on child nicotine poisoning August 11, 2014. On behalf of organizations dedicated to improving the health and safety of children, we write to express our support for the Child Nicotine Poisoning Prevention Act of 2014. This legislation recognizes the danger that liquid nicotine used to refill electronic cigarettes poses to small children and gives the U.S. Consumer Product Safety Commission (CPSC) the authority to require the use of child-proof packaging on liquid nicotine containers sold to consumers.
Cancer Prevention and Treatment Fund joins more than 3 dozen groups in supporting bills that ban hormone chemicals from food and beverage cans Read the text of the letter, signed by dozens of health and cancer related organizations, below: July 9, 2014 The Honorable Lois Capps 2231 Rayburn House Office Building Washington, DC 20515 The Honorable Grace Meng 1317 Longworth House Office Building Washington, DC 20515 Dear Representative Capps and Representative Meng, The undersigned organizations are pleased to … Continue reading Cancer Prevention and Treatment Fund joins more than 3 dozen groups in supporting bills that ban hormone chemicals from food and beverage cans
Members of the Patient, Consumer, and Public Health Coalition strongly support the Research for All Act of 2014 To view as a PDF, click here. June 5, 2014 The Honorable Jim Cooper 1536 Longworth HOB Washington, DC 20515 Re: Members of the Patient, Consumer, and Public Health Coalition strongly support the Research for All Act of 2014. Dear Congressman Cooper, As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Research for … Continue reading Members of the Patient, Consumer, and Public Health Coalition strongly support the Research for All Act of 2014
Letter to House Appopriations Chairman and Ranking Member on opposition to cigar exemption To view as a PDF, click here. May 27, 2014 The Honorable Harold Rogers Chairman Committee on Appropriations United States House of Representatives Washington, DC 20515 The Honorable Nita Lowey Ranking Member Committee on Appropriations United States House of Representatives Washington, DC 20515 Dear Chairman Rogers and Ranking Member Lowey: We are writing to express our … Continue reading Letter to House Appopriations Chairman and Ranking Member on opposition to cigar exemption
Coalition letter to FDA Commissioner about approving Cobas HPV test alone (without pap smear) and FDA response April 14, 2014. We are writing as members of the Patient, Consumer, and Public Health Coalition and other interested experts to express our grave concerns about the March 12, 2014 FDA meeting of the Microbiology Medical Devices Panel of the Medical Devices Advisory Committee. Under consideration was the premarket approval of a new indication for the Cobas HPV test, as a first-line primary screening tool for cervical cancer in women aged 25 and older.
Letter to Director, Center for Tobacco Products FDA Michell Zeller on tobacco product regulation March 27, 2014. The Surgeon General’s conclusion that the increased risk of lung cancer to smokers is due to changes in cigarette design and composition has critical implications for FDA’s regulation of tobacco products.
Letter to The Honorable Kathleen Sebelius on comprehensive cessation benefit To view letter, click here. February 19, 2014 The Honorable Kathleen Sebelius U.S. Department of Health and Human Services Hubert H. Humphrey Building 200 Independence Avenue, SW, Room 120F Washington, DC 20201 Dear Secretary Sebelius: We are writing to ask your Department to clearly define a comprehensive tobacco cessation benefit in the Affordable Care Act regulations or, … Continue reading Letter to The Honorable Kathleen Sebelius on comprehensive cessation benefit
Open letter to America’s retailers, especially those with pharmacies from leading public health and medical organizations As organizations committed to ending the tobacco epidemic in the United States, we applaud the bold decision by CVS Caremark to eliminate the sale of cigarettes and other tobacco products in all its stores.
Comments of the Patient, Consumer, and Public Health Coalition on HELP Committee’s Draft Proposal on Pharmaceutical Compounding The Patient, Consumer, and Public Health Coalition expressed concern that the draft does not adequately address the public health threats posed by compounding pharmacies and will not do enough to prevent future health care crises and offers a number of suggested revisions.
Letter to Representative Markey in Support of Legislation that would give FDA Authority to Oversee Compounding Pharmacies, October 31, 2012 This letter expresses support for Massachusetts Representative Ed Markey’s proposed legislation that would give the FDA more authority over compounding pharmacies.
Letter to Senator Patrick Leahy, in support of the Camp Lejeune Historic Drinking Water Consolidated Document, August 31, 2012 The Cancer Prevention and Treatment Fund thanks Senator Patrick J. Leahy for his leadership regarding the Camp Lejeune Historic Drinking Water Consolidated Document Repository. The contamination of drinking water at Camp Lejeune Marine Corps Base is an unprecedented environmental disaster affecting the courageous men and women of our military.
Letter to Dr. Margaret Hamburg, FDA Commissioner, about Maintaining and Strengthening Conflict of Interest Policies for Advisory Committees In this letter to FDA Commissioner, Dr. Margaret Hamburg, NRC and other coalition members advocate for stronger conflict of interest requirements for members of FDA advisory committees to protect patients and consumers against industry biases.
Report: Medical Devices Lack Evidence of Safety and Effectiveness July 29, 2011. The prestigious Institute of Medicine (IOM) released a report on the Food and Drug Administration’s 510(k) medical device clearance process stating the system is “flawed” and should be revised. The report echoes the National Research Center for Women & Families’ concerns about the lack of evidence that these devises actually work and are safe.
Letter to Maine House of Representatives on the Children’s Wireless Protection Act February 26, 2010. We strongly support the “Children’s Wireless Protection Act.” This legislation would require cell phones sold in Maine to include a prominent warning label on the phone and its packaging stating that the device may cause brain cancer, that children and pregnant women should be particularly cautious, and that people should keep the phones away from their heads and bodies.