On Health Policy Archives

NCHR Testimony at the Nonprescription Drugs Advisory Commitee on OTC Antiseptics

September 3, 2014. We are all aware of the important role that OTC antiseptics play in reducing the risk of infection, particularly in the healthcare setting. That is why it is crucial to ensure that the ingredients in these products are as safe and effective as possible.

Patient, Consumer, and Public Health Coalition Comments on the Up-Classification of Flu Detection Tests

August 20, 2014. Members of the Patient, Consumer, and Public Health Coalition strongly support the up-classification of influenza detection devices. We support moving the devices from class I to class II with special controls and into a new device classification regulation (from 21 CFR 866.3330 to 21 CFR 866.3328). We agree with the FDA that “the accuracy of these devices has serious public health implications,” since influenza can cause serious illness and death.

NCHR Testimony at 2014 National Antimicrobial Resistance Monitoring System Scientific Meeting

August 13, 2014. We urge the participating agencies to ensure that NARMS receives the funding that it needs to maintain and build upon these vital efforts. Antibiotic resistant infections are estimated to cost the U.S. healthcare system between $21 and $34 billion dollars every year.

Statement of Dr. Diana Zuckerman Regarding Deadly Water at Camp Lejeune in North Carolina

August 14, 2014. A new study shows that the contaminated drinking water at USMC Base Camp Lejeune from the 1950s to 1985 was deadly to civilians working there as well as the active military and their family members living there.

Patient, Consumer, and Public Health Coalition Comments on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

August 11, 2014. Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance for the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.” We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.”