Excerpt: Thank you for your letter of July 7, 2015, cosigned by three of your colleagues, concerning ongoing efforts by the Food and Drug Administration (FDA or the Agency) to combat the opioid abuse epidemic and to more effectively incentivize the development and broadened use of evidence-based practices and treatments.
On September 19 2014, we wrote the commission to express concerns about the inappropriate use of “qualitative factors” by Nuclear Regulatory Commission (NRC) staff in the development of cost benefit analysis for regulatory decisions. The expansion of this practice threatens to undermine NRC’s long established practice of conducting rigorous, quantitative, cost-benefit analysis to justify its regulatory decision-making. Increased reliance on the subjective judgments also undermines NRC’s core
Letters to Planned Parenthood, Advanced Bioscience Resources, Inc., Novogenix Laboratories, and StemExpress Regarding Human Tissue Sale and/or DonationAugust 7, 2015 | Letter
Excerpt: As you know, in several recent videotapes made public, these individuals have made statements concerning the manner in which fetal tissue is procured. We are examining whether these statements accurately reflect PPFA’s position on the acquisition and disposition of fetal tissue, and whether their statements, if accurate, are consistent with existing laws.
Excerpt: On June 4, 2015, the NIH Clinical Center suspended operations of its Pharmaceutical Development Section after the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. This followed an inspection conducted by the FDA from May 19-29, 2015, which found a series of deficiencies in the PDS physical facility.
EPA’s pending rule threatens serious economic harm and is being proposed as the nation continues to face major fiscal and employment challenges, including stagnant wages and a low labor participation rate.
Excerpt: The mismatched seasonal influenza vaccine and the high death rate among the elderly and other high-risk populations in the U.S. during the 2014-2015 influenza season highlight the need for an improved response, including making seasonal influenza vaccines more effective and promptly available. We believe understanding the lessons from the 2014-2015 influenza season could improve the U.S. public health response in the future and possibly save thousands of lives.