Advocacy at a Glance

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.

• President’s Budget to be Released February 2. The President’s proposed budget for FY 16 will be released on Monday. Based on the President’s decision not to adhere to Budget Control Act (BCA) spending caps, it is possible to see very good numbers for the FDA – certainly we are hoping to have much better numbers than in the past few years.  We know that he will be proposing an end to across-the-board sequestration, an expanded initiative on antibiotics, and a new initiative on “precision medicine” (personalized medicine). Some details of the antibiotic expansion were released by the White House in advance. Notably, of the $1 billion that would go to DHHS, more than $650 million would be given to the NIH and the Biomedical Advanced Research and Development Authority (BARDA) and more than $280 million would go to CDC. FDA’s share, $47 million, would be to support evaluation of new antibacterial drugs for patient treatments and antibiotic stewardship in animal agriculture.  As we review and interpret his request early next week, we will send additional information to Alliance members.

• Please Use Caution in Evaluating the Administration’s Initial FDA Numbers.  While we are hoping for strong numbers for FDA appropriations in the President’s proposal, keep in mind that in past years the President has included unauthorized user fees.  As a result, “the percentage increase” claimed for FDA is likely to be exaggerated in the initial press release.  We will perform an analysis as quick as possible, but keep in mind the initial public numbers are likely to be inaccurate.

• Alliance Members: Two Great Panels are Lined Up for our Quarterly Meeting this Tuesday, February 3, at 1 p.m.  In addition to a previously announced panel of Energy and Commerce Staff, we are pleased to announce that FDA Budget Director Bill Tootle will first present on the President’s FY16 FDA budget request.  Deputy Commissioner for Foods, Michael Taylor, will join for a few minutes on the phone.  FDA will present at 1 p.m., and our original featured guests -- majority and minority staffers from the House Energy and Commerce Committee — will now speak at 2 p.m. and then answer questions from the moderator and audience.  They will be discussing the Energy & Commerce Committee’s agenda for 2015, including the 21st Century Cures Initiative. Special note: This is a members-only meeting, and will be closed to the media. Non-members who wish to attend should e-mail Tony Curry.

• Senate Ag/FDA Appropriations Subcommittee Members Named. While we knew last week that Senator Jerry Moran of Kansas would be the new subcommittee chair and Jeff Merkely of Oregon would be the ranking minority member, the rest of the subcommittee has now been named. In addition to Chairman Moran, the Republicans will be Roy Blunt (R, MO),  Thad Cochran (R, MS), Mitch McConnell (R, KY), Susan Collins (R, ME), John Hoeven (R, ND), and Steven Daines (R, MT). In addition to Ranking Member Merkely, the Democrats will be Dianne Feinstein (D, CA), Jon Tester (D, MT), Tom Udall (D, NM), Patrick Leahy (D, VT), and Tammy Baldwin (D, WI).

• Debt Ceiling Showdown Likely in September, Rather than March.  On March 17, the U.S. government will once again bump up against its borrowing ceiling. The last few times this has happened the U.S. Treasury has undertaken extraordinary means to stretch the deadline and give Congress additional time to authorize a higher ceiling. CBO now predicts that the Treasury Department can extend its borrowing capacity until September or October. This could move the fight into the same timeframe as Congressional action to fund FY 16 — whether by appropriation bills or continuing resolution. Despite this coincidence, House Speaker Boehner and Senate Majority Leader McConnell have repeatedly stressed that they will not leave the government without borrowing authority or allow the government to shut down.

• Commissioner Hamburg Appoints New Deputy.  Dr. Hamburg has appointed Dr. Robert Califf to be FDA Deputy Commissioner for Medical Products and Tobacco.  As such, he oversees the drug and biologic centers, the radiation health and medical device center, and the tobacco center. Dr. Califf is considered a global leader in clinical research.

• CBO: Deficit Will Shrink Through 2017, Then Start Growing Again. The Congressional Budget Office (CBO) has issued a report on the federal deficit, now and in the future. Existing budget restraints and an improving economy will reduce the annual federal deficit in 2016 and 2017. After that, starting in 2018, there is an increasing gap between the federal government’s income and expenditures, with the consequence that the deficit will grow. The increasing cost of entitlement programs is the main driver and the timing reflects the aging of the baby boomers.