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.

• LATE-BREAKING. We have been told that President Trump has signed an order today directing every federal agency to convene a task force to review existing regulations and make recommendations on which can be withdrawn or modified to lessen their burden on the economy. We have not yet seen a copy of the text. The order is not a surprise. In last week’s Advocacy at a Glance we wrote: “Because the existing 2-for-1 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.” The long-term impact on FDA will not be known until the agency task force comes back with its recommendations.

• Congress Returns from Recess Next Week; Budget and Appropriations Schedules Slowly Coming Together. It was widely reported this week that the Trump Administration plans to send Congress an FY 18 budget blueprint on March 14. A more detailed budget proposal is likely to reach the Hill in May.

Meantime, President Trump will be addressing Congress on February 28 to lay out some of his priorities. Among them is likely to be significant cutbacks in federal spending, consistent with his message that cabinet departments (presumably excluding Defense and Homeland Security) will need to operate with a lot less money in FY 18. The White House reiterated this week that their priorities are repeal of the Affordable Care Act, budget and tax reform.

For more discussion of this year’s budget and spending struggles and FDA’s place within the debate, please read this week’s Analysis and Commentary.

• No Further Clarification on Hiring Freeze and “2 for 1” Regulatory Policy. Last week’s Advocacy at a Glance represents our most recent analysis of the impact of the hiring freeze and the “2 for 1” regulatory policy initiatives. As described, the impact of the short-term hiring freeze on FDA is unclear, but may not make much difference given its limited duration and the breadth of exemptions for employee categories relating to health, safety and biosciences. The Alliance’s focus is on the longer-term plan being developed by OMB/OPM and due by the end of April. That is the critical one if FDA is to avoid losing employee slots by attrition.

Similarly, we think the impact of the “withdraw two old regulations for every new regulation proposed” is uncertain, but its impact on FDA won’t be as great as first feared. The precise situation won’t become clear until FDA and OMB reach consensus on which regulations are under $100 million in their impact, or required by a specific date specified by Congress or the Judiciary or subject to waiver from OMB. The type of analysis required will look much like this, which covers regulations for drug compounding and was published on the FDA Law Blog.

• HHS Secretary Price Tours FDA. According to an Inside Health Policy story this week, Secretary Price met with FDA leaders and toured the White Oak campus on February 16. His subsequent tweet concluded: “The work @US_FDA does touch the lives of every American.”

• Alliance Member Circulating Letter Calling for Exempting NIH and FDA from the President’s Hiring Freeze. The Everylife Foundation for Rare Diseases, a long-standing Alliance member, is circulating a letter from the patient community to President Trump calling on him to exempt NIH and FDA from the hiring freeze. If you are interested in the letter and want to consider signing on, go to this link or contact Max Bronstein at 415-884-0223.
• Alliance Co-Founder, Wayne Pines, Publishes Op-ed on Prospects for FDA in the New Administration. Wayne Pines, a long-time Alliance Board Member and former President, is out today with a new op-ed, being published in Morning Consult, entitled “FDA Ain’t Broke, Doesn’t Need Fixing.” In the op-ed, he argues for tweaks at FDA, but not a major overhaul. Be sure to give it a read!