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.

• Alliance Board of Directors Sets FY 18 “Ask” at $2.8 Billion. The Alliance for a Stronger FDA’s Board of Directors met on February 16 and, among other things, discussed and decided how much the Alliance should ask for in the FY 18 appropriations cycle. Their conclusion: $2.8 billion in budget authority appropriations. This is $78 million above the amount appropriated in FY 16 and available to the agency under the FY 17 continuing resolution. This “ask” is a 3% increase and is separate and apart from the $60 million in off-budget monies that we hope will be available to FDA to implement specific provisions of the 21st Century Cures legislation. More details about the Alliance’s board decision is contained in this week’s Analysis and Commentary.

• Uncertain Effects on FDA of Hiring Freeze and Regulatory 2-for-1; Second Phases to Come. As reported in last week’s Advocacy at a Glance, the clarifying memo from HHS on the hiring freeze lead us to believe that much, if not all, of FDA vacancies will exempt from the short-term freeze. We are still waiting for further clarification to be certain of this conclusion. Meantime, the Alliance will be working hard to have FDA exempted from the long-term OMB/OPM plan for reducing the federal workforce. The report is due by the end of April. The freeze will continue until the long-term plan is implemented.

Also, as reported last week, the latest OMB guidance -- explaining the new requirement that two regulations must be eliminated for every new one proposed -- is likely to have some effect on FDA, but not the dramatic sweeping change that was feared. Among other things, the order applies only to major regulations, defined as in excess of $100 million in impact. In addition, the latest guidance does not define the exemption for regulations that are “required by law,” which might cover a number of upcoming FDA efforts. Further clarification will be needed, but we do not know whether it will take the form of additional public guidance from OMB or case-by-case determinations negotiated between FDA and OMB’s Office of Information and Regulatory Affairs (OIRA).

Because the existing order is only triggered by new regulations, we anticipate a phase 2, in which agencies will be asked to identify and trim existing regulations beyond what would be needed to carry out the 2-for-1. This is speculative since the terms and timing of such a directive have not been publicly discussed, but it is the logical extension of the President’s stated goal of large-scale reduction in regulations.

• Update on HHS Secretary Price. This was Secretary Price’s first full week, one that he appears to have spent focused on repeal of the Affordable Care Act (Obamacare). We are unaware of any actions he might have taken with regard to FDA. Within the next few weeks, we expect the appointment of a Deputy Secretary of HHS, which is a Senate-confirmable position. Only after that occurs do we expect that there will be announcements about leadership for agencies within HHS, notably FDA Commissioner. For comparison purposes, in 2009, Dr. Hamburg was nominated mid-March and was confirmed by mid-May.

• Alliance Member Circulating Letter Calling for Exempting Public Health Service Agencies from the President’s Hiring Freeze. The Infectious Disease Society of America (IDSA), a long-standing Alliance member, is circulating a letter to the Administration calling on them to exempt the following agencies from the hiring freeze: CDC, NIH, HRSA, and FDA. If you are interested in the letter and want to consider signing on, contact Amanda Jezek at IDSA either by e-mail or by phone at (703) 740-4790.

• GAO Report Updates Their Call for Consolidation of Federal Food Safety Programs. In a report released on February 13, GAO updated its findings on the “high risk” represented by multiple federal agencies having food safety responsibilities. The report finds that:

  the fragmented federal oversight of food safety has caused inconsistent oversight, ineffective coordination, and inefficient use of resources. The safety and quality of the U.S. food supply is governed by a highly complex system stemming from at least 30 laws that are collectively administered by 15 federal agencies. We added federal food safety oversight to the High Risk List in 2007 because of risks to the economy, to public health, and to safety.

• Development Around FDA/White Oak Advances. As reported by the Washington Post, the Montgomery County Council has voted to go forward with the sale to a developer of 110 acres adjacent to FDA’s White Oak campus. This will be combined with other parcels owned by the developer and eventually become a life sciences campus, commercial space, and housing. Yet another nearby site under development will become the new Washington Adventist Hospital. From past briefings by FDA, we know that they are interested in ways of developing synergies once the development around the perimeter of the campus -- both the hospital and the life sciences center -- becomes a reality.