November 29, 2011. NCHR signs on to a letter opposing the Regulatory Accountability Act (RAA) (H.R. 3010/S. 1606) and the Regulations from the Executive in Need of Scrutiny (REINS) Act of 2011 (H.R. 10/S. 299) to protect a safe food supply, clean air and water, and a variety of consumer protections for American families.
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NCHR Testimony at the Public Meeting on Prescription Drug User Fee Act (PDUFA) Reauthorization
October 5, 2011. “Everyone in this room agrees that we want safe and effective drugs to be on the market in the U.S. as soon as possible. Where we don’t always agree, however, is what is appropriate evidence of what is safe or effective, and how to weigh the potential risks and potential benefits.”
Read More »Institute of Medicine Report: Medical Devices Lack Evidence of Safety and Effectiveness
July 29, 2011. The prestigious Institute of Medicine (IOM) released a report on the Food and Drug Administration’s 510(k) medical device clearance process stating the system is “flawed” and should be revised. The report echoes the National Research Center for Women & Families’ concerns about the lack of evidence that these devises actually work and are safe.
Read More »Testimony of of Dr. Diana Zuckerman at Senate Special Committee on Aging Hearing on Medical Devices
April 13, 2011: Dr Diana Zuckerman of NCHR testified at a Senate Special Committee on Aging Hearing on medical devices, explaining FDA low standards for approval. She said lives could be saved and patients would spend less time in the hospital if FDA implemented the law as required. Billions of Medicare dollars could be saved.
Read More »NCHR Comment to the FDA on Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process
March 19, 2010. Many people in the medical device industry claim that stricter standards for clearing or approving medical devices will stifle innovation.
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