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.

• Appropriations Action by December 8 Unlikely; New CR Being Discussed. As discussed in prior updates, Congress cannot finish appropriations until it has resolved the conflict between proposed defense spending levels for FY 18 and the much lower budget ceiling on defense spending provided in the Budget Control Act of 2011. With tax legislation pre-occupying Congress, we have been told there has been little progress on resolving the cap situation and virtually no chance of an omnibus (or minibus) appropriations bill by the time the current CR expires on December 8. At this point, there seems to be a split between those who want week-to-week extensions of the CR to keep the pressure on ... and those who feel that a CR through February is more realistic.

• Why Does the Alliance Advocate for Funding All of FDA? From the beginning, the Alliance has advocated for increased funding for all of FDA. We believe that “a rising tide lifts all boats.” However, the reasons behind our broad advocacy run deeper. This week’s Analysis and Commentary explores some of the thinking that has guided the Alliance to advocate for the entire agency.

• ORA Reorganization: Built on Increased Specialization and Expanding Foreign Inspections As reported by FDANews, FDA's Assistant Commissioner for Medical Products and Tobacco Operations (in the Office of Regulatory Affairs) recently spoke about the reorganization of ORA and how that will change inspections and field operations. She pointed to ORA’s efforts to hire more experts from outside the agency and build the inspection process around more sophisticated IT systems. She also spoke of foreign inspections as an increasingly important function of the renewed ORA organization.

• Something to Watch: Commissioner Gottlieb’s Evolving Approach to Nutrition Policy. Commissioner Gottlieb has expressed his commitment to broader initiatives in the area of nutrition policy, based on what he feels are strong linkages with disease and death. This week, he unveiled new Congressionally-mandated menu labeling guidance in draft form, using an approach he termed “practical, efficient and sustainable.” Based on press accounts, it seems the guidance was well received. Even for those not interested in nutrition policy, there may be reasons to watch: it could be a way to understand how the commissioner intends to carefully carry out the agency’s public health responsibilities in an anti-regulatory environment.