Science Board Issues Latest Report on FDA and Regulatory Science and more
Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.
Alliance Quarterly Meeting -- Conference Call Only. The Alliance’s third quarter member meeting -- scheduled for Tuesday, August 4 at 1 p.m. will be a conference call. This will be a relatively brief call to discuss the status of appropriations for FY 16, as we move into the August recess.
Appropriations Update. The Senate Committee on Appropriations cleared its final appropriations measures, marking the first time since 2009 that all 12 appropriations bills have been approved by the full committee. The House hit this same milestone in mid-July and, in addition, several appropriations bills have passed the full House. The Senate is not expected to take up the appropriations bills until/unless there is a deal to raise the budget caps. The House is stalled for now, as well. The attached document provides an overview of the proposed numbers for FDA from each committee. For the prospects for this year’s appropriations bills, especially Ag/FDA, please read today’s Analysis and Commentary.
Science Board Issues Latest Report on FDA and Regulatory Science. In 2007, the FDA Science Board released a report, FDA Science: Mission at Risk. This catalogued the many ways in which FDA funding had fallen behind and jeopardized the scientific mission of the agency. It served as a catalyst for increased funding. As an eight-year follow-up, the FDA Science Board has released a progress report, FDA Science Moving Forward. It concludes that both organizational changes and program accomplishments have improved the scientific infrastructure, management, and application of regulatory science to enhance FDA’s regulatory mission. While informative, the progress report had a more limited mission than the original report and the adequacy of FDA’s funding is not commented upon.
Bipartisan Policy Center (BPC) Report on Advancing Medical Innovation. The BPC released a report, Advancing Medical Innovation for a Healthier America. The focus is on the discovery phase of innovation and the FDA’s role in providing an efficient and effective regulatory process. The report takes no position on whether additional funding will be necessary, only noting that implementing its recommendations might require it.
NIH Has Third “Bypass Budget” for Alzheimer’s Disease. One of the unique aspects of NIH funding is that the agency’s cancer and HIV research budgets are sent to Congress without being altered by HHS or OMB. (They can comment only.) The idea has now spread, to Alzheimer's, with NIH fulfilling a Congressional directive to produce a “bypass budget” for research above baseline to meet the goal to treat and prevent the disease by 2025. NIH’s estimate is that it will take $323 million dollars extra in FY 17 to meet this goal.