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 FY 17 Budget Request to be Released this Tuesday, February 9. In most years, OMB releases the President’s budget request by 10:00 to 11:00 a.m. on the morning of the target day. The Alliance will then be scrambling to find the (often) buried Congressional Justification for FDA funding, which will contain all the details. By early afternoon, DHHS usually does a budget briefing. Afterwards, usually at 2:00 or 3:00 p.m., FDA will do its own public briefing.

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 and inflation-adjusted growth in existing user fees in claiming growth in FDA funding. In particular, “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 significantly overstated. More on this and related topics are discussed in this week’s Analysis and Commentary.

• State Agriculture Officials State FSMA Policy Preferences. The National Association of State Directors of Agriculture met for their winter meeting and reaffirmed their desire to have an expanded collaborative role with FDA during continued implementation of FSMA. One of the keys to FSMA is that states are to play an active role in inspections and thereby avoid needless duplication of resources between federal and state food safety efforts.

• Obama-Proposed “Cancer Moonshot” Includes Monies for FDA. As part of his “cancer moonshot” initiative, President Obama has proposed the creation of a virtual Oncology Center of Excellence to stimulate cross-center and cross-disciplinary coordination of product evaluation and of development of diagnostics and combination products. It is believed that FDA will receive a $75 million increase as part of the President’s proposed initiative. As to the underlying authority behind the requested appropriations, both House E&C Chairman Upton and Senate HELP Chairman Alexander have pointed to the Cures/Innovation legislation as an appropriate vehicle.

• President Obama Will Propose a $1.1 Billion Initiative to Combat Opioid Epidemic. So far, all the proposed funding is likely to go to treatment programs funded through the Public Health Service and CMS. However, given FDA’s prominent role in approving products that are have abuse-deterrent, as well as new painkillers and addiction fighting products, there is a strong case that some of these proposed new monies should go to FDA.

• Califf Nomination: New Opioid Policies May Impact Senators’ Holds. There remain four “holds” on a Senate confirmation vote on Dr. Califf’s nomination to be FDA Commissioner: Senators Murkowski, Sanders, Markey, and Manchin. The White House has signaled their continued strong support for his nomination. Efforts continue to address the issues that prompted the “holds.” As reported by Politico: Sen. Richard Burr, one of Robert Califf's biggest supporters on the Hill, is stressing that FDA “needs a permanent Commissioner.” For the Alliance’s view on the confirmation effort, see last week’s Analysis and Commentary.

At least two of the holds on Dr. Califf’s nomination are premised on FDA actions and inactions related to opioid abuse. In response to those and in keeping with the President’s new opioid initiative, on February 4, FDA released sweeping new policies to combat opioid addiction.