Letter from Members of the Patient, Consumer, and Public Health Coalition Re: HELP Committee’s Draft Proposal on Pharmaceutical Compounding

May 6, 2103 — 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. The Coalition provided comments on how to improve the draft to better protect the American public. Continue reading

Comments on Effective Date for Premarket Approval for Three Class III Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose

May 6, 2013 — As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for the three preamendment devices referred to in this docket because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness. Continue reading

NRC and Patient, Consumer, and Public Health Coalition comments to FDA: Don’t need a new pathway for antibiotics for limited populations!

January 30, 2013 — The FDA considered a new way to approve drugs for use in small patient populations. NRC warn that such a pathway would put patients at risk of harm by giving them poorly studied drugs without knowing if the drugs provide any benefit. Continue reading

Letter to Key U.S. Senators in Support of Funding for the Affordable Care Act

April 2, 2013 — Like you, members of the Patient, Consumer, and Public Health Coalition are very supportive of the Patient Protection and Affordable Care Act (ACA). We were extremely disappointed that the Hatch-Klobuchar amendment (S. Amdt. 297 to S. Con. Res. 8) to repeal the 2.3% excise tax on medical devices was overwhelmingly supported. Thank you very much for your important vote against the amendment. Continue reading

Letter in support of the Delivering Antimicrobial Transparency in Animals Act

April 2, 2013 — Letter to Representatives Henry Waxman and Louise Slaughter supporting the DATA act, which would require better reporting of how antibiotics are used in animals raised for food. This information is critical to understanding how antibiotic resistant bacteria in food animals affects human health. Continue reading

Statement of Dr. Diana Zuckerman Regarding Legislation to Require Warning Letters to Women with Dense Breasts To Nevada Assembly

March 11, 2013 — Among experts in women’s health and experts in breast cancer, there is considerable concern about Assembly Bill 147 and similar legislation in other states. While we agree that women with dense breasts should discuss the implications of that health condition with their physician, we are concerned that women who receive required form letters are more frightened than informed. Continue reading

Letter to Congressman Edward J. Markey regarding the VALID Compounding Act of 2012

October 31, 2012 — As members of the Patient, Consumer, and Public Health Coalition, we thank you for your commitment to the health of patients and consumers by introducing the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012. This bill would strengthen FDA oversight of compounding pharmacies in several essential ways, and is clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths. Continue reading

Letter from Members of the Patient, Consumer, and Public Health Coalition Re: FDA’s Recent HELP Committee testimony on pharmacy compounding

November 30, 2012 — As members of the Patient, Consumer, and Public Health Coalition, we welcome the opportunity to provide our views regarding FDA Commissioner Margaret Hamburg’s November 15, 2012 testimony at the HELP Committee hearing, “Pharmacy Compounding: Implications of 2012 Meningitis Outbreak.” Continue reading

Letter from Members of the Patient, Consumer, and Public Health Coalition Re: “Questions for Stakeholders Regarding Appropriate Regulation of Pharmacy Compounding”

November 2, 2012 — Members of the Patient, Consumer, and Public Health Coalition welcome the opportunity to provide our views regarding pharmacy compounding.  Stronger regulations are clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.  Current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk. Continue reading

Notre Dame football players rape cover-up – what’s in the news and what isn’t

January 9, 2013 — The media has extensively covered the college championship football game between Notre Dame and Alabama, but few Americans aware of Notre Dame’s cover-up of rapes by Notre Dame football players. Monday’s football game is an opportunity to acknowledge that raping women is a terrible crime that needs to be taken seriously by the police, the public, and the media. Continue reading

Testimony of Dr. Jennifer Yttri on Bedaquiline

November 28, 2012 — Dr. Yttri testifies to the FDA Committee that the data on bedaquiline indicate that the benefit to patients with multi drug resistant tuberculosis is questionable. The FDA’s responsibility is to approve drugs that will help, not harm, consumers. Treatments exist for patients with multi drug resistant tuberculosis that are safer without the addition of bedaquiline. Continue reading

Statement by Senior Fellow Jennifer Yttri, PhD, at FDA Public Hearing on Antiseptic Preoperative Skin Preparation Products

December 10, 2012 — Dr. Yttri testifies to the FDA on the serious public health issue of contamination of antiseptic products. First, we support the recommendation of the August 2009 Advisory Committee in ensuring that all antiseptic patient preoperative skin preparation products are held to current good manufacturing practice (GMP) standards. Second, the FDA should remove ineffective antiseptics from the market. Third, as extrinsic contamination accounts for the majority of contamination outbreaks, FDA should require product packaging that would reduce extrinsic manipulation. Finally, while the majority of outbreaks seem to be related to extrinsic contamination, intrinsic contamination introduced during manufacturing most likely accounts for a greater number of contaminated products. Continue reading

Statement from Dr. Jennifer Yttri, senior fellow, at the FDA public hearing establishing a list of qualifying pathogens for the GAIN act

December 18, 2012 — Dr. Yttri testifies to the FDA that the growing risk of antibiotic resistant pathogens and need for development and responsible use of new antibiotics are critical public health concerns that need to be addressed. Continue reading

Testimony of Brandel France de Bravo, MPH On External Counter-Pulsating (ECP) Devices

December 5, 2012 — We do not support the FDA’s recommendation to down-classify ECPs for refractory chronic stable angina. We would support allowing the ECPs that are currently on the market to be allowed to stay on the market with labeling to include the phrase “all 510(k) cleared ECPs are prohibited from being used for any indication other than refractory chronic stable angina.” We urge you to require all new versions of ECPs to be classified as Class III and go through the more rigorous PMA process for any uses. Continue reading

Letter to Dr. Joshua Sharfstein, Maryland’s Secretary of Health, in support of banning the sale of baby bumper pads in Maryland, September 28, 2012

September 28, 2012 — The ASTM standard that claims some bumper pads are less risky will muddle the safety issue even more and give parents a false sense of security. Maryland’s proposed ban on crib bumper pads will help to protect more than 70,000 babies born in the state each year, and that is a bottom line upon which we should all agree. Continue reading

Comments on Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses

October 4, 2012 — Members of the Patient, Consumer, and Public Health Coalition strongly support the FDA’s proposed rule to require Premarket Approval Application (PMA) for the Class III preamendments device Shortwave Diathermy (SWD) for all other uses except for the treatment of malignancies. However, we oppose FDA’s proposal to allow a Product Development Protocol (PDP) instead of a PMA for this device because PDPs are for devices where a sponsor comes to an “early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.” FDA has stated unequivocally that SWD devices “have not been shown to be safe and effective” therefore, the devices have no public health benefits, and that also rules out the use of a PDP. Continue reading

Testimony of Dr. Diana Zuckerman, President at the FDA Advisory Committee Hearing on Metal-on-Metal Hip Implants

June 27, 2012 — Metal-on-metal hip implants were approved by the FDA without requiring clinical studies before approval or following patients after their surgery for potential side effects. Now, 500,000 patients have metal-on-metal implants that have been widely reported to wear down and create metal debris inside patients’ bodies. Dr. Zuckerman testifies to the FDA about the lack of long-term clinical trials at their Advisory Committee hearing. Continue reading

Comments on Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose; Effective Date of Requirement for Premarket Approval for Sorbent Hemoperfusion Devices To Treat Hepatic Coma and Metabolic Disturbances

May 17, 2012 — To ensure public health and patient safety, sorbent hemoperfusion devices for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances should remain class III devices and go through the more stringent PMA process, which requires clinical trials and inspections. Continue reading

NRC Comment on a FDA Guidance on the Evaluation of Sex Differences in Medical Device Clinical Studies

March 19, 2012 — The National Research Center for Women and Families has been a long-time advocate of medical device clinical studies including data on safety and effectiveness for women. In this comment letter to the FDA, we describe the importance of analyzing data for women separately and how this information should be used to help women and providers make the best informed decisions. Continue reading

Statement of Paul Brown, In Support of the Ensuring Safe Medical Devices for Patients Act

March 15, 2012 — Paul Brown, NRC’s Government Relations Manager released a statement supporting Senator Merkley’s bill, “Ensuring Safe Medical Devices for Patient Act” that requires the Food and Drug Administration (FDA) to establish a Unique Device Identifier (UDI) rule by the end of year and add medical devices to the Sentinel system. Continue reading

Comments on Proposed Rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

January 17, 2012 — As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices. Continue reading

FDA needs to provide breast implant patients and physicians with unreported industry data about quality of life, connective tissue symptoms, rupture rates per patient, and other complications

January 5, 2012 — At the FDA Advisory Panel meetings in 2003 and 2005, FDA provided and presented data from the Breast Implant Core studies regarding connective tissue disorder (CTD) signs and symptoms (S/S) and Quality of Life measures. Continue reading

Letter to Dr. Margaret Hamburg, FDA Commissioner, regarding maintaining and strengthening conflict of interest policies for advisory committees

August 3, 2011 — 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. Continue reading

Testimony of Dr. Diana Zuckerman on Transvaginal Mesh

September 9, 2011 — We agree with the FDA that serious adverse events from mesh are NOT rare. No man or woman wants to suffer from incontinence, but there is no doubt that the terribly painful complications can be much worse than the incontinence that initially led to surgery. And, those complications are often impossible to repair. Continue reading

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. Continue reading

Study on Medical Device Recalls Released Today

February 14, 2011 — Our new study finds that most medical devices recalled during the last five years for “serious health problems or death” were originally cleared (approved) by the Food and Drug Administration (FDA) using a less stringent process that does not require testing in patients. The study, released on-line on February 14 prior to publication in the Archives of Internal Medicine, was co-authored by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. Continue reading

Circulatory System Devices Panel Meeting: Slide Presentation- Diana Zuckerman, Ph.D President, National Research Center for Women & Families

January 25, 2011 — Researchers have reported that more than 20 percent of the almost one million AEDs in circulation were recalled by the FDA. Hundreds of people have died due to AED malfunctions. Innovation in design isn’t worth anything if the product doesn’t work when needed. Continue reading

Letter from the Patient, Consumer, and Public Health Coalition to Jeffrey Shuren, Director, Center for Devices and Radiological Health (FDA), about improving medical device safety

January 18, 2011 — We strongly believe that improving the standards needed to prove safety and effectiveness of medical devices will ensure that U.S. companies flourish and create jobs at the same time as they contribute to public health. Continue reading

Statement of Diana Zuckerman, Ph.D., President National Research Center for Women & Families at the FDA Advisory Committee Meeting on Lorcaserin

September 16, 2010 — In addition, I am a fellow at the University of Pennsylvania Center for Bioethics, and a board member for two nonprofit organizations that work to improve resources for the FDA: the Alliance for a Stronger FDA, and the Reagan Udall Foundation. Continue reading

Statement of Diana Zuckerman, Ph.D., President National Research Center for Women & Families at the FDA Advisory Committee Meeting on Meridia

September 15, 2010 — The big questions facing you is: how dangerous is Meridia; do the benefits outweigh the risks and if so, for whom; and is there any way to control its use so that those who would truly benefit from Meridia can buy it, but those who are likely to be harmed by it can’t buy it. Continue reading

Statement of Diana Zuckerman, Ph.D., President, at the FDA Public Meeting on the Reauthorization of the Medical Device User Fee Act (MDUFA)

September 14, 2010 — My perspective is as a researcher trained in epidemiology and public health at Yale Medical School, with experience doing research at Vassar and Harvard, as a fellow at the University of Pennsylvania Center for Bioethics, and as a former Congressional staffer focused on FDA issues. Continue reading

Comments to the FDA on “Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner”

June 28, 2010 — These proposed changes are steps in the right direction, but we continue to have strong reservations about DTC prescription drug ads, and we will continue to urge Congress to restrict or ban DTC ads. Continue reading

Comments to the FDA on “Food Additives; Bisphenol A”

June 4, 2010 –The Patient, Consumer, and Public Health Coalition-which includes nonprofit organizations that represent patients, consumers, scientists, and researchers-is commenting on documents prepared by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) regarding the safety assessment of Bisphenol A (BPA). Continue reading

Statement of Diana Zuckerman, Ph.D., Regarding Senate Bill 213 “Child Care Articles and Toys Containing Bisphenol-A – Prohibition”

February 17, 2010 — Bisphenol A (BPA) is a chemical used to make plastics, and is frequently used in baby bottles, water bottles, and medical devices. It is also used in an epoxy coating on the inside of almost all food and beverage cans-including infant formula cans. Continue reading

Letter to U.S. Senator Harry Reid (Majority Leader) requesting that he introduce or cosponsor legislation to remove the HPV vaccine from the U.S. Citizenship and Immigration Services (USCIS) requirements

December 4, 2009 — I am writing to inform you of an outrageous new requirement by the U.S. Citizenship and Immigration Services (USCIS) for women applying for visas to enter the United States or adjustment of resident status. Continue reading

Testimony of Dr. Diana Zuckerman to the FDA Public Hearing on Promotion of Medical Products via the Internet and Social Media

November 12, 2009 — Those of us who are here know that our concerns are shared by many other public health, patient, and consumer organizations. However, most do not have the staff or resources to set aside two days of unscheduled time for a meeting, especially non-reimbursed time, and especially in the middle of the health care reform negotiations. Continue reading

Letter to Dr. Margaret Hamburg, FDA Commissioner, urging that immediate attention be brought to appropriately regulate tanning devices

November 5, 2009 — Members of the Patient and Consumer Coalition urge your immediate attention to appropriately regulate tanning devices. As you know, currently, tanning devices are Class I devices (the same as bandages), which is the U.S. Food and Drug Administration’s (FDA) lowest risk device class and does not require comprehensive safety data. Continue reading

Comments to the U.S. Consumer Product Safety Commission on “Statement of Policy: Testing of Component Parts With Respect to Section 108 of the Consumer Product Safety Improvement Act”

September 16, 2009 — Given that phthalate concentrations can be diluted in large toys, we agree with Commission staff that testing phthalate content as a percentage of the entire toy or child care article is less effective than testing materials and component parts that may contain phthalates. Continue reading

Comments to the FDA on “Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket”

September 14, 2009 — The National Research Center for Women & Families submits the following comments regarding the laser-assisted in situ keratomileusis (LASIK) and the post market experience associated with the use of LASIK devices. Continue reading