June 23, 2014. As members of the Patient, Consumer, and Public Health Coalition, many of whom have worked with your staff for years, we are writing to express our concerns that you have not worked with us in your role as a leader in the 21st Century Cures project.
Read More »On Health Policy
Lawmakers Respond to Advocates’ Concerns About Innovation Initiative
FDA Week, July 17, 2014. Lawmakers appeared to respond to concerns that the House Energy & Commerce Committee is receiving a one-sided, industry-backed patient perspective as part of its 21st Century Cures Initiative by soliciting comments July 11 from other groups and calling for a balance between the push for more expedited approvals and public health safeguards.
Read More »NCHR Testimony at the Advisory Committee on Minority Health, Department of Health and Human Services
July 8, 2014. Racial and ethnic minorities are rarely included in sufficient numbers in clinical trials used as the basis of FDA approval of drugs and medical devices. And yet, these are the medical products that all patients — including millions of people of color — rely on.
Read More »Patient, Consumer, and Public Health Coalition Concerned that Proposed Regulatory Framework for Health Information Technology Will Undermine FDA’s Mission
July 7, 2014. Health care providers and patients rely on the FDA to establish that a device is reasonably safe and effective. If FDA does not carefully scrutinize health IT products to evaluate evidence that those that are devices have benefits that outweigh the risks, patients may be seriously harmed.
Read More »Hill Briefing — Reforming the FDA: The Impact of Proposed Changes on Patients and Health Policy
June 12, 2014. Hill Briefing to learn more about the research, physician, and patient perspectives on proposed legislation aimed at improving FDA policies for the approval of drugs and devices.
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