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.

• OMB Clarifies Some Details on the President’s Federal Hiring Freeze. A week after the President announced a federal government-wide hiring freeze, OMB and OPM issued a guidance document to help agencies determine which, if any, of their vacancies are subject to the freeze or exempt from it. Overall, the guidance document seems to be encouraging from an FDA perspective, but is not definitive on a number of points. For example, mention of safe food and drugs as being within exempt categories is extremely helpful, but someone, presumably at OMB or HHS, must still decide whether FDA can interpret this exemption broadly or must implement it narrowly. One clear positive: vacancies in the Commissioned Corps at FDA are now officially exempt.

The position of the Alliance for a Stronger FDA is that all FDA vacancies should be considered part of protecting public safety and therefore exempt from the current hiring freeze, as well as any long-term reduction by attrition that might be contained in a forthcoming OMB long-term plan for reducing the federal workforce. For more on the hiring freeze and other initiatives of the Trump administration, please read this week’s Analysis and Commentary.

• Freeze on New Regulations Morphs Into Policy to Eliminate Two Regulations for Every Proposed New Regulation. Following up on his campaign promise to cut federal regulation by 70% to 80%, President Trump, through OMB, announced the details of his program for federal agencies to eliminate two regulations for every new one they propose. Broad rules are laid out in the announcement, such as that agencies will not be required to eliminate the two regs at the same time as they propose the new one.

However, there is still significant additional detail needed before it becomes clear what impact the policy will have on FDA. For example, it appears that regulations required by statute may be exempt. On the other hand, the White House told Politico that: “guidance documents — which the FDA has issued in lieu of formal rules — apply to Trump's order if they interpret or implement law or policy.” For more on the President’s new regulatory policy, please read this week’s Analysis and Commentary.

• House and Senate Ag/FDA Appropriations Subcommittee Leadership Now Fully in Place. 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. There also continues to be speculation that Representative Aderholt may be appointed to take Senator Sessions’ (R, AL) Senate seat should the Senator be confirmed. That continues to be speculation at this point. Rep. Sanford Bishop (D, GA) has been announced to be Ranking Democrat on the Subcommittee. He is a longtime Agriculture/FDA appropriator, and he replaces Rep. Sam Farr (D, CA) who recently retired. On the Senate Side, the new Ag/FDA Appropriations Subcommittee Chair is Sen. John Hoeven (R, ND). Sen. Jeff Merkley (D, OR) continues as Ranking Member.

• Trump Administration/Some Members of Congress Interested in Sweeping Budget Cuts to Reach a Balanced Budget Within a Decade. As described recently in Roll Call, the Trump Administration has been talking to two conservative organizations -- the Heritage Foundation and the Republican Study Group -- about their budgetary blueprints for long-term deficit reduction. According to the article, the new Administration is expected to submit an FY 18 budget outline to Congress in late February with a target for a complete budget proposal by May. Early indications are that the President, with support from within Congress, will be looking to make major cuts in spending, focusing on domestic discretionary programs and possibly on entitlements.

• Commissioner Appointment Watch and Trump Administration at FDA. Prior to meeting with pharmaceutical executives earlier this week, President Donald J. Trump stated, “We have a fantastic person that I think I'll be naming fairly soon who's going to streamline the FDA." Should the President announce an appointment this month, he will be slightly ahead of the Obama Administration, which announced Commissioner Hamburg’s nomination in March of 2009. While the Alliance won’t speculate on the names being floated in the media for the Commissioner position, two members of HHS Beachhead Team have landed at FDA. Anna Abram (longtime FDA policy advisor for Sen. Richard Burr [R, NC]) and former Bush 43 HHS Alumnus Jack Kalavritinos have office space at FDA headquarters at the White Oak Building.