September 16, 2014. This draft guidance only applies to companies who “voluntarily choose” to correct misinformation that appears on the Internet or through social media platforms from third party entities. However, companies should be held responsible for the accuracy and balance of all information about their product that appears to be promotional, not just for sources they voluntarily choose to correct.
Read More »On Health Policy
Letter to Senate Committee on Generic Labeling Regulations
September 9, 2014. In November 2013, the Food and Drug Administration (FDA) proposed to revise its regulations to allow generic drug manufacturers to initiate safety updates to their products’ labeling. We strongly support the FDA’s proposal.
Read More »Comments on Distributing Risk Information for Approved Prescription Drugs and Biological Products
August 25, 2014. As members of the Patient, Consumer and Public Health Coalition, we strongly urge the Food and Drug Administration (FDA) to withdraw its draft guidance proposing to allow pharmaceutical firms to distribute to health care providers and facilities scientific medical literature suggesting that the risk information for prescription drugs and biological products are less than what is stated in the FDA-approved product labeling.
Read More »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.
Read More »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.
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