On Health Policy Archives

Comments on Proposed Order Regarding Cranial Electrotherapy Stimulator Devices

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 cranial electrotherapy stimulator devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.

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

May 6, 2013. 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.

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.

Comments to the FDA on Premarket Approval for Metal on Metal Hip Replacements

April 18, 2013. 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.

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

April 2, 2013. 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.