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Advocacy at a Glance

February 7, 2020

TOPLINE: This week’s Advocacy at a Glance announces a number of Alliance activities to which our members are invited to participate. This includes both Hill and FDA events, as well as a webinar on modernization of FDA’s technology. Guidance is provided on the President’s budget release scheduled for February. Finally, this week’s Analysis and Commentary reviews the Alliance’s meeting with Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health.

UPCOMING ALLIANCE EVENTS

  • FEBRUARY 19: For Medical Products Stakeholders. February 19 webinar with Dr. Amy Abernethy, FDA Principal Deputy Commissioner and Acting Chief Information Officer. In September, the FDA released its Technology Modernization Action Plan (TMAP), which is intended to guide the multiple technological infrastructure needs of the agency and affects every consumer, patient, and company that looks to the FDA for scientifically-based decisions. To discuss the report and its implementation, Dr. Abernethy, will participate in an Alliance webinar, starting at 4:15 on February 19. The webinar is open to Alliance members and the media. If you would like to join in, please contact Reed Diskey for call-in directions.
  • MARCH 18: For All FDA Stakeholders. March 18 (Wednesday) is the Alliance’s Hill Day. Please mark your calendars. We will be setting up dozens of Hill meetings, so we can use participants all day or just in the morning or the afternoon. You do not have to be an Alliance member to be part of our Hill Day.
  • APRIL 1: For Food Safety Stakeholders. April 1 meeting at FDA with Frank Yiannis,  Deputy Commissioner for Food Policy and Response. This will be an Alliance members-only meeting. This is the third of our FDA meetings this year.

Please let Reed know if you would like to participate in any of these events.

FY 21 President’s Request to Be Released on Monday, February 10. The President’s FY 21 budget request will be released on February 10 by OMB and more detailed documents are likely the same day or soon thereafter.  Last week’s Analysis and Commentary (here) looks at the timing of that process and the key steps that must take place before enactment. Also described are the main Alliance activities designed to make the case to Congress that FDA needs additional resources. Our theme is: FDA’s growing responsibilities require a budget that grows.

Under FY 21 Budget Caps, Little Room for Growth in Non-Defense Spending. The FY 21 budget ceiling for non-defense discretionary (NDD) programs is only $5 billion above the actual FY 2020 spend. This is less than 1% growth and not nearly enough to cover just the increased costs and initiatives at VA and for homeland security. This suggests that the President’s budget will have to propose cuts to a broad swath of NDD spending.  Congress could respond in many ways, including a budget work-around for VA costs or an increased NDD budget ceiling.

Next Week, Media Will Circulate Inflated OMB “Headline Numbers” for FDA; Wait for Alliance Analysis. Regardless of who is in the White House, OMB tries to place the President’s request in the best light. As a result, OMB’s “headline numbers” for the FDA, which are widely used by media, overstate the amount of funds being proposed. Here are just some of the reasons: proposed user fees are counted as actual funding, even though they are unlikely to become law; annual increases built into the user fee agreements are treated as new dollars proposed by the President; and more than $700 million of user fees are for the tobacco center and not available for FDA’s traditional responsibilities (see: tobacco fees distort the FDA’s budget, here.)

We urge our readers to wait for the Alliance’s analysis of increases (or decreases) in FDA funding proposed by the President. For those not inclined to wait: once the Congressional Justification document becomes available, I compare information in the All-Purpose Table and the Summary of Changes with the numbers in the Budget Authority Crosswalk and Budget Authority by Activity tables.

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