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.

• Senate Appropriations Marks-Up Ag/FDA Funding Bill. The Senate Appropriations Committee held its mark-up of the FY 16 Ag/FDA funding bill this week and advanced the bill. FDA received a net increase of $40 million in BA appropriations. Food safety activities are to receive an additional $45 million and medical product programs an additional $5 million. These additions are offset by acceptance of FDA’s proposal for $10 million in administrative savings. The total BA funding for FDA would be $2.628 billion under the House bill. Senator Durbin offered an amendment to increase food safety spending by $69 million, which was rejected by the committee. He has vowed to continue his efforts. To see how each FDA Center and line item fares under the Senate bill, please read this week's Analysis and Commentary.

• FSMA: Hearings in the Senate/In-Depth News Coverage. According to Politico, Sen. Jerry Moran, the chairman of the Senate Appropriations Ag/FDA Subcommittee's expects to hold hearings on the FDA and FSMA after the fiscal 2016 spending bill advances. Politico also published a lengthy article analyzing the FDA/FSMA budget situation and why FSMA has not been fully funded.

• New FDA Report on Targeted Drug Development; FDA Deputy Commissioner Califf Provides Highlights. In an FDA Voice column entitled "More Collaboration, Research Needed to Develop Cures", FDA Deputy Commissioner for Medical Products and Tobacco, Robert Califf, MD, describes a new FDA report analyzing why certain disease areas are advancing faster than others. Dr. Califf highlights improvements to regulatory science, such as biomarkers, that have made the drug review and approval process more efficient. He calls for greater efforts to support translational science that will help fill the pipeline in disease areas that are less well developed.

• House Appropriations Process Grinds to a Halt, At Least Temporarily. The House’s goal of passing all 12 appropriations bills hit a snag when House Republican leadership pulled the Interior and Environment appropriations bill just as it was scheduled for floor action. The immediate cause was a dispute over restrictions on display of the Confederate flag on federal lands. As has been the case on several occasions, Republican leadership faces dissent from a conservative minority, leaving it without sufficient votes for passage of legislation unless leadership compromises with House Democrats. As of this writing, no other appropriations bills are likely to be considered until the Confederate flag issue is resolved. Many commentators have suggested that the appropriations process is now over for FY 16, which we think is a premature conclusion.