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.

• Trump Era Begins at HHS and FDA. A beachhead team arrived at HHS and many of its Operating Divisions (including FDA) this week, following a timeline that we described in last week’s Analysis and Commentary. Stat News had previously reported that Jack Kalavritinos, a former HHS political appointee in the George W. Bush years who has also worked in the private sector at Covidien, would be on the beachhead team. Anna Abram, who has been Senator Burr’s (R, NC) longtime health policy director and a member of the Senate HELP committee professional staff, was listed in a Politico report as a beachhead team member. Abram has significant FDA policy and legislative experience. According to Politico, Paula Stannard, a member of the transition team, has been listed as the “senior White House advisor” on the beachhead team. With this title, Stannard appears to be the senior-most staff on the HHS beachhead team. She has significant Food Drug and Cosmetic Act legal experience as a former acting-General Counsel of HHS in the George W. Bush Administration and in her subsequent private practice.

Meantime, Stephen Ostroff, FDA’s deputy commissioner for foods has been named as Acting Commissioner. He is expected to serve in that position until a new Commissioner is nominated and confirmed. Several names are in circulation of possible appointees for Commissioner, but it is hard to know when an announcement will be made. For frame of reference, 8 years ago Commissioner Hamburg was nominated in mid-March and confirmed in mid-May.

• Hiring Freeze Threatens FDA; Critical Details Not Yet Announced. Since the election we have been predicting a federal hiring freeze, so it was no surprise that President Trump issued a Presidential Memorandum on January 23 ordering a freeze. It will remain in effect until OMB submits and implements a comprehensive plan for reducing the federal work force (requested by the President within 3 months). The order freezes all new hiring, except national security, public safety and military. Since FDA has many hundreds of vacancies, the most important question for FDA stakeholders is: will the agency, in whole or part, be exempt from the freeze? The answer is unclear so far and the freeze represents a serious potential threat to FDA -- more than 80% of the agency budget is dedicated to direct and indirect costs of personnel.

As we interpret the Presidential Memorandum, the eventual decider will be the Secretary of HHS, subject to guidance that OMB and OPM have not yet provided to departments and agencies. For a more complete discussion of the Memorandum and its implications for FDA, read this week’s Analysis and Commentary. The Alliance has already begun information gathering and advocacy to raise concern about the potential negative impact of the Memorandum on FDA.

• Regulatory Freeze in Place; Permanent Policy Not Yet Set. After the Inauguration (January 20), White House Chief of Staff Reince Priebus issued a memorandum to all federal department and agency heads. It states that agencies cannot send new regulations to the Office of the Federal Register (OFR) and must withdraw regulations that have been sent to OFR, but have not yet been published. For regulations that have been published in the Federal Register but have not taken effect, their effective date would be postponed to at least 60 days from the date of the memorandum. Excluded from the freeze are any regulations subject to statutory or judicial deadlines, as verified by the OMB Director.

The purpose of the freeze is to assure that “the President's appointees or designees have the opportunity to review any new or pending regulations.” However, what is not mentioned in the memorandum is how the freeze might be used as a bridge to President Trump’s campaign pledge to “eliminate two regulations for every new one proposed.” Nonetheless, this type of regulatory freeze is not unusual as a new Administration begins to examine potential agency activity.

• Appropriations Committee Leadership Updated. On the Senate side, the new chairman of the Ag/FDA subcommittee will be Senator John Hoeven (R, ND). He is a longtime Agriculture Appropriations Subcommittee Member, has been in the Senate since 2011, and previously spent a decade as Governor of North Dakota. Jeff Merkley (D, OR) will continue as the ranking Democrat. The committee will be made up of seven Republicans: Chairman Hoeven, Full Committee Chairman Thad Cochran (R, MS), Majority Leader Mitch McConnell (R, KY), Susan Collins (R, ME), Roy Blunt (R, MO), Jerry Moran (R, KS), and Marco Rubio (R, FL). There will be six Democrats: Ranking Member: Merkley, Dianne Feinstein (D, CA), John Tester (D, MT), Tom Udall (D, NM), Patrick Leahy (D, VT), and Tammy Baldwin (D, WI).As previously reported, on the House side, Congressman Robert Aderholt (R, AL), who was Ag/FDA subcommittee chair in the last Congress, will continue in that role for the new Congress. Subcommittee Ranking members have not yet been yet announced. Importantly, Rep. Sam Farr, the previous ranking member on Ag/FDA appropriations 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.

• 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.