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.

• Hiring Freeze Guidance Circulated by HHS; FDA’s Status Uncertain. HHS has distributed a guidance to agency heads and staff that provides significantly more information about which vacancies are exempt from the current, short-term hiring freeze. The list includes physicians, pharmacists, consumer safety officers, and other job categories that are familiar to those interacting with FDA. Further, based on review of an FDA webpage of jobs that have been advertised in the recent past, there appears to be good alignment between the series numbers on HHS’s list of exempt employment categories and many of FDA’s personnel needs. However, the Alliance is intentionally being cautious in interpreting what seems like good news. The federal employment system is arcane and complex, and without expert knowledge, there may well be distinctions that we might not recognize in reviewing the HHS list. For example, we are not positive that a series 401 biologist (listed in the HHS memo as exempt) would cover all, some, or none of the biologist vacancies at FDA.

While the details of the short-term hiring freeze are being worked through, the key to FDA’s future will be in the long-term hiring plan being put together by OMB and OPM over the next 90 days. With upwards of 1000 vacancies, FDA’s situation may be among the most dire in the entire federal government. Further, as the Alliance often points out: FDA carries out core responsibilities of government, no one will carry out its functions if the agency is not there, and, importantly, FDA is the only federal regulatory agency with support of consumers, patients and industry. For those reasons, we will continue to advocate for all vacancies to be exempt from short- and long-term hiring freezes. For more on the hiring freeze and other initiatives of the Trump administration, please read this week’s Analysis and Commentary.

• Capitol Hill Wants FDA Vacancies to be Filled. Lawmakers understand that FDA needs to be able to fill vacancies and make new hires to implement its many statutory responsibilities. On January 30, eight Senators voiced these concerns through a letter to Acting Commissioner Ostroff. Then on February 7, a letter was sent to OMB by Representatives Fred Upton (R, MI) and Diana DeGette (D, CO) emphasizing the Congress’ commitment to FDA through the 21st Century Cures legislation, as expressed in provisions to improve FDA recruitment and by giving FDA new and additional responsibilities.

• White House Plan to Cut Regulations Has Been Clarified But Impact on FDA Still Uncertain. The scope of the White House plan for cutting regulations is starting to take shape and the impact, while large, may be less than many have feared. While government agencies can trim existing regulations on their own initiative, the immediate focus is establishing a quid pro quo for new regulations to be issued in FY 17. Further, Interim Guidance issued by OMB says the “2 for 1” program applies only to "significant" regulations (defined in a 1993 Executive Order as costing $100 million or more). Also, there is no guidance yet on the meaning of the exemption for regulations “required by law,” which may be relevant to FDA. Other considerations are raised here.

Taken altogether, it is possible that much of FDA’s consolidated regulatory agenda may not be covered or can be delayed beyond the end of FY 17. With specific regard to food safety, Food Safety News has reported that the bulk of FSMA regulations, as well as the more complex ones, have already been promulgated. Pending items would be “proposed rules for food lab accreditation standards, requirements for posting recall notices, and traceability for high-risk foods -- all under FSMA. It not clear whether that work will occur in 2017 or also wait until next year.”

• Tom Price Becomes New HHS Secretary. The Senate has confirmed Tom Price as the new Secretary of HHS and he will be sworn into office today. Many believe this will be a turning point in the naming of other senior HHS officials who themselves will require Senate confirmation. During last week’s meeting with representatives of the pharmaceutical industry, President Trump indicated that a decision had been made about a new commissioner. The presumed hold up was the confirmation of Representative Price to be HHS Secretary. If so, the logical progression would be for an announcement of the Deputy Secretary of HHS then sometime afterward the Commissioner of FDA.

• New Senator from Alabama: Luther Strange. Alabama Governor Robert Bentley appointed Luther Strange, Alabama’s Attorney General, to fill the vacancy left by Jeff Sessions upon his confirmation as United States Attorney General. There had been some speculation that Rep. Robert Aderholt (R, AL) might be appointed, but with this decision made, we look forward to continuing to work with Mr. Aderholt as Chair of the House Appropriations Ag/FDA Subcommittee.