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.

• Welcome to This Week’s Friday Update. You are receiving this on Thursday because tomorrow is Inauguration Day. We will be back on our regular schedule next Friday, January 27. Meantime, today’s Analysis and Commentary asks the question: "Will next Monday be different than today?" Not surprisingly, the answer is, “Yes.”

• Appropriations Committees Organizing for New Congress. On the House side, new Appropriations Chairman Rodney Frelinghuysen announced that the current Ag/FDA subcommittee chair, Congressman Robert Aderholt (R, AL) will continue in that role for the new Congress. Ranking member Nita Lowey has not yet announced who will be ranking on the Ag/FDA subcommittee. Importantly, Rep. Sam Farr, the previous ranking member has retired, so we know it will be someone new. Further changes may be in the mix: there is some speculation that Representative Aderholt may be appointed to take Senator Sessions (R, AL) Senate seat should the Senator be confirmed as Attorney General. However, it remains speculation at this juncture. On the Senate-side, subcommittee assignments have not yet been made by Chairman Cochran. However, Senator Leahy, the new Full Committee ranking member, has announced that Jeff Merkley (D, OR) will continue as the ranking Democrat on the Agriculture Appropriations Subcommittee.

• Senate HELP Chairman Lamar Alexander Focused on FDA Workforce Issues. At yesterday’s confirmation hearing for Secretary-nominee Dr. Tom Price, HELP Chairman Alexander had an early reference to some of the workforce challenges that FDA faces, and referenced new language meant to address that in the 21st Century Cures bill. Specifically, Chairman Alexander stated: “We made important changes in the Food and Drug Administration, giving them new authority, new responsibility; for example, new authority to hire and pay the experts they need to move products and devices through the FDA at a more rapid rate, saving time and money and getting those devices into the medicine cabinets and the doctors offices.” While the hearing largely focus on ACA-related issues some of other FDA highlights included:
  • Ranking Senator Patty Murray (D, WA) on FDA Gold Standard and Tobacco: In her opening statement, Senator Murray stated, “So I will want to hear from you about whether and how you would uphold the gold standard of FDA approval and for example, how you would approach important programs and rules intended to keep tobacco companies from luring children into addiction.”
  • Senator Pat Roberts (R, KS) on Food Safety and Nutrition: Referencing the Obama Administration, he stated, “I'm concerned that the administration did not prioritize FDA's mission to protect our nation's food supply, instead focusing on nutrition policies.”
  • Senator Al Franken (D, MN) on Tobacco: “As a physician, you may know, I guess you didn't, that smoking kills approximately 480,000 Americans each year and totals $170 billion each year in health care costs. And yet, between 1993 and 2012, you were a shareholder of tobacco -- big tobacco companies, meaning that you personally benefited from tobacco sales. Meanwhile, you voted against landmark legislation in 2009 that gave the FDA the authority to regulate tobacco.”

• Prepping for the New Congress: Macro- and Micro-Budget Considerations for FDA. The Alliance often distinguishes between the macro- and the micro-budget. The macro-budget is the entirety of Federal spending (about $4 trillion), of which just over $1 trillion is spent on discretionary programs (defense, social programs, FDA, etc.). FDA-relevant macro-budgetary considerations include the annual budget deficit, spending allocations provided to each appropriations subcommittee and caps on defense and non-defense spending. In contrast, the micro-budget is all about FDA. How much did the President request? How much will the House and Senate appropriate? And particularly pertinent: Does Congress perceive that FDA monies are well spent and that there is a strong rationale for prioritizing growth at FDA over other pressing demands? While macro-budgetary struggles grab headlines and can dramatically affect how much (or how little) is available to spend, in most years it is Congress’ micro-budgetary judgment of FDA that drives the agency’s appropriation. Because of the limited ability of any interest group to impact macro-budgetary issues, the Alliance’s focus is on FDA’s micro-budget.

• Administrative Item – Dues Payments. In December, we sent a 2017 dues invoice to the primary contact of each Alliance member. Please let us know if you did not receive one. To the extent you can put it into processing as early as possible, we greatly appreciate it.