July 30, 2013. As members of the Patient, Consumer, and Public Health Coalition, we recognize the need for new drugs to reach patients with serious or life-threatening diseases. The pipeline for new antibacterial drugs is shrinking. However, we have grave concerns about proposals to change the standards for meeting FDA’s requirement of two “adequate and well controlled” trials.
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NCHR Testimony at FDA Advisory Committee on Reclassification of Blood Lancets
June 26, 2013. Blood lancets, used to test blood sugar levels in diabetics or to obtain blood samples from finger pricks, have been considered a low risk medical device, like band-aids. However, FDA and CDC have found that blood lancets being used on multiple patients have resulted in increasing numbers of hepatitis outbreaks. In a statement to the FDA, NRC made the claim that blood lancets are medium and high risk devices, that require more regulation than low risk devices.
Read More »Coalition Comments on Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System
June 24, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA proposed order that will require the premarket approval application (PMA) for Automated External Defibrillators systems (AEDs). However, we oppose the FDA exercising an enforcement discretion that would allow 510(k) cleared AEDs to remain on the market for 15 months after FDA issues a final order requiring a PMA for these devices.
Read More »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.
Read More »Letter to Congressman Markey in Support of VALID Act About Compounding Pharmacies
May 22, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2013. This bill would significantly strengthen FDA oversight of compounding pharmacies and help ensure patients get safe and effective life-saving medical products.
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