FDA/Medical Innovation Policy Development Efforts Multiple 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.
Commissioner Hamburg Resigns, Effective March 30. All our readers are aware that Commissioner Hamburg announced her resignation this week. We will miss Dr. Hamburg’s willingness to speak publicly regarding the resource needs of the FDA. Her many accomplishments -- across the entire spectrum of food and medical product programs, as well as her response to globalization -- are a legacy that any FDA commissioner would be proud to claim. FDA’s chief scientific officer, Stephen Ostroff will become acting commissioner upon Dr. Hamburg’s departure.
FDA/Medical Innovation Policy Development Efforts Multiple. The House Energy and Commerce Committee’s 21st Century Cures initiative has garnered the most attention, but is not the only effort to look at FDA issues. On the Senate side, HELP chairman Lamar Alexander (R, TN) and Sen. Richard Burr (R, NC) have released a report identifying areas in need of improvement within FDA and the National Institutes of Health and soliciting feedback from stakeholders on ways to improve drug and medical device development. Yet another effort is being undertaken by the Bipartisan Policy Center with former Republican Senator Bill Frist leading a one-year FDA modernization initiative. The BPC is describing the project as a “new bipartisan initiative to examine the time and cost currently involved with medical product discovery and development, and how to better align public policies to support medical innovation.”
House and Senate Ag/FDA Appropriations Subcommittees Planning Quick Start. According to Politico, but still unofficial: FDA Commissioner Margaret Hamburg will testify before the House subcommittee on March 4. Similarly, Dr. Hamburg is expected to testify before the Senate subcommittee on March 11, although that has not yet been announced. In addition, the House subcommittee has sent around a “Dear colleague” letter asking Members to submit requests for appropriations funding to the subcommittee before March 23. Members are cautioned not to submit requests for specific program earmarks.
President Releases His FY 16 Budget Request for FDA. The President requested $148 million in additional budget authority (BA) appropriations for FDA. Specifically, $109.5 million is requested for food safety, $33.2 million for medical products, and $5 million to update the White Oak Master Plan. The Alliance welcomed the request, which came to nearly a 6% increase (see press release). The Administration has issued an informative 1-page highlight summary and a fuller description of the food safety program funding. The full Congressional Justification can be found here. In this week’s Analysis and Commentary, Alliance deputy executive director, Steven Grossman, provides some further reflections on the content of the budget request and the context in which it will be considered.