Public Policy
Comments to the FDA on “Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis”
The National Research Center for Women & Families and the TMJ Association oppose the reclassification of Temporary Mandibular Condyle prosthesis, a preamendments class III device, into class II. The proposed special controls are not rigorous enough to provide a reasonable assurance of the device’s safety and effectiveness. Read More
Comments from Members of the Patient, Consumer, and Public Health Coalition Re: 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. The Coalition provided comments on how to improve the draft to better protect the American public. Read More
Testimony of Dr. Diana Zuckerman at the FDA meeting on Juvederm Voluma XC
Testimony on Juvederm Voluma XC FDA Advisory Committee on General and Plastic Surgery Devices, Caitlin Kennedy, Senior Fellow, May 2, 2013 Read More
Testimony by Jennifer Yttri, PhD, senior fellow to the Oncology Advisory Committee of the FDA on tivozanib for kidney cancer
Dr. Jennifer Yttri testified at the FDA that more information is needed on the safety and benefits of the drug tivozanib before it should be considered for treatment of advanced kidney cancer. Read More
NRC and Patient, Consumer, and Public Health Coalition comments to FDA: Don’t need a new pathway for limited populations!
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. Read More
NRC Comments to the FDA on Premarket Approval for Metal on Metal Hip Replacements
The NRC strongly supports the FDA’s proposed order to require that metal on metal hips be approved through the premarket approval (PMA) process, which requires more rigorous testing of the devices than the current 510(k) process. Read More
Letter to Key U.S. Senators in Support of Funding for the Affordable Care Act
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. Read More
Letter supporting Delivering Antimicrobial Transparency in Animals Act
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. Read More
Letter to Senator Tom Harkin in Support of the “Healthy Families Act”
We strongly support the “Healthy Families Act.” Thank you for sponsoring this important legislation, which would create a national standard for paid sick days. Read More
Letter to Congresswoman Rosa DeLauro in Support of the “Healthy Families Act”
We strongly support the “Healthy Families Act.” Thank you for sponsoring this important legislation, which would create a national standard for paid sick days. Read More