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.

• Barring a Last-Minute Deal, A Partial FDA Shutdown is Likely. While a last-minute deal is still a possibility, the greater likelihood is that a quarter of the federal government, including portions of FDA, will be without funds (by CR or appropriation) at midnight tonight -- December 21. The key questions then become: For how long? and How will if affect FDA? Both are addressed in this week’s Analysis and Commentary.

Topline Alliance messaging on a partial shutdown of FDA: Concern.  The FDA regulates products that make up 20% of consumer spending in the US.  The agency’s responsibilities cannot be fully met when 7,000 employees are furloughed. Further, when the FDA is not fulfilling its critical public health responsibilities, there is no backstop to the agency’s work.

Having said that, we have confidence that Dr. Gottlieb and FDA leadership have ensured that the emergency and critical public health and safety functions will be covered during a shutdown. Consumers should not panic -- the FDA is still on the job.  The immediate problem, quite a serious one, is the slowing of work on longer-term priorities and items that aren’t absolutely essential.  Managing only those items that could turn into an immediate crises is no way to run an agency that is critical to public health.

How many people will be furloughed?  59% (10,344) of FDA employees will be retained and 41% (7,053) will be furloughed, according to HHS documents.

Commissioner Gottlieb Directly Engaged.  Commissioner Gottlieb has sent a note to all FDA employees; he has indicated that each employee will be receiving an informal notice of their employment status later this afternoon, if a lapse in appropriations were to occur.  The commissioner’s communication is available here.

• Alliance to Host FDA Deputy Commissioner for Policy. Alliance members and media are invited to our next meeting -- on Tuesday, January 29 from 2:00 p.m. to 3:00 p.m. Our guest will be Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis at FDA. Her remarks should provide valuable insight into FDA’s priorities for 2019. To RSVP, please click here.

• Farm Bill Signed into Law. On December 20, President Trump signed the 2018 farm bill into law, with two items that affect FDA. The final bill provides for the full legalization of industrial hemp. In Sec. 297D, the Managers clarify that the Secretary of Agriculture has authority to issue guidelines and regulations regarding the production of hemp. However, the legislation also preserves the authority granted to the FDA and HHS to regulate  hemp-derived products. Sec. 12516 of the Farm Bill provides labeling exemptions from section 403(q) of the Federal Food, Drug, and Cosmetic Act for single ingredient foods and products.

• No Friday Update on December 28th.We wish all our readers a happy holiday and a wonderful new year. Our next edition of Friday Update will be on January 4, 2019.