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 »On Health Policy
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.
Read More »Letter to Congressman Cooper Strongly Supporting the Research for All Act of 2014
June 5, 2014. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Research for All Act. It would require the FDA to develop policies to ensure that clinical trials for medical products granted expedited approval are sufficient in design and size to determine the safety and effectiveness for men and women, using subgroup analysis.
Read More »Letters to Senate Leadership Supporting the Medical Device Excise Tax
June 4, 2014. We thank you for being an outstanding champion of the Affordable Care Act (ACA), and we strongly support your position that a repeal of the 2.3% excise tax on medical devices should not be included in the Tax Extenders Act.
Read More »NCHR Testimony at the FDA Pregnancy Registries Meeting
May 28, 2014. Pregnancy exposure registries tend to be too small and have often not recruited sufficient numbers of racial and ethnic minorities. The biggest challenge is obtaining information on a drug’s safety during pregnancy as quickly as possible after a new drug is marketed.
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