September 18, 2014. We are writing to express our strong concerns about proposed legislation to speed the development of new antibiotic drugs, H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013. Antibiotic resistance is of grave concern, but this legislation will create more problems than it will solve.
Read More »On Health Policy
Letter to Senator Booker Supporting the Securing Assistance for Victim Empowerment (SAVE) Act
September 23, 2014. We strongly support this legislation to end the tax-exempt status of major professional sports leagues and use the money saved for domestic abuse programs. We strongly agree with your statement that “stopping domestic violence is a national priority that requires long-term, meaningful investment.”
Read More »Comments on Draft Guidance for Industry on Internet/Social Media Platforms
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 This draft guidance only applies to companies who “voluntarily choose” to correct misinformation that appears on the Internet or through social media platforms from third party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 »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Patient, Consumer and Public Health Coalition, we strongly urge the Food and Drug Administration (FDA) to withdraw its draft guidance proposing to allow pharmaceutical firms to distribute to health care providers and facilities scientific medical literature suggesting that the risk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.
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