FDA Meets Congressional Deadline for Publication of Abuse-Deterrent Opioid Guidance 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.
FDA Meets Congressional Deadline for Publication of Abuse-Deterrent Opioid Guidance. In the final FY 15 appropriation bill, Congress demanded that FDA publish its final guidance on evaluation and labeling of abuse-deterrent opioids. Failure to do so by June 30 would have resulted in the FDA losing $20 million in funding. With FDA’s April 1 publication of the final guidance the threat has been eliminated.
Congress to Return Next Week. After a 2-week recess, the House and Senate will come back into session the week of April 13. For more about the Congressional schedule and its impact on appropriations and FDA, read this week’s Analysis and Commentary.
Dr. Hamburg to Continue as an Advocate for FDA; Becomes Foreign Secretary at IOM. In her last public address and a radio interview, outgoing FDA Commissioner Hamburg made clear that she will continue to be an advocate for the agency, including its resource needs. Also, it was announced that Dr. Hamburg has been appointed as the next foreign secretary of the Institute of Medicine, the health arm of the National Academy of Sciences. In this capacity, Hamburg will advise the IOM president and council and serve as “liaison to foreign academies of medicine and science.”
FDA to Hold Symposium on Extramural Research and Regulatory Science. FDA’s Office of Regulatory Science and Innovation (ORSI) is holding a one-day scientific symposium on April 27 to showcase extramural research collaborations to advance FDA's Regulatory Science Initiative. The symposium will highlight progress in ORSI-supported research projects such as those funded through FDA's Centers of Excellence in Regulatory Science and Innovation and through the Agency's Broad Agency Announcement. The Symposium will give stakeholders the chance to further scientific collaboration with FDA in its scientific priority areas.
Hill Briefing: Advancing Research & Treatments for Parkinson’s Disease. Alliance member, Parkinson’s Action Network (PAN), will be holding a Hill briefing at 4 p.m. on April 22 in the Rayburn Building. They have invited Alliance members to attend. For more information, please e-mail Jennifer Sheridan Palute at PAN.
Chairman Moran to Visit FDA Facility. Senate Ag/FDA appropriations subcommittee chair, Jerry Moran (R, KS), will be visiting the FDA’s Kansas City District Office next week. Among other things, the office is responsible to the Office of Regulatory Affairs for “the planning, receipt, preparation, and analyses of approximately 280 food items common in the American diet, including infant/toddler foods.”