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Advocacy at a Glance

May 8, 2021

Top-Line: Hill Days focusing on Senate staff on May 25 and 26. Alliance webinars upcoming with CDER Director Cavazzoni and FDA’s food and animal health leadership. AI is expected to supplant telehealth as the top health investment priority. FDA’s technology and data modernization needs present a challenge and opportunity.

Hill Day Part 2: Meetings with Senate Staff on May 25 and 26. Please Sign Up.While we continue to wait for the key details in the President’s Budget Request, the Alliance completed a round of House meetings and has scheduled Senate meetings for May 25 and 26. We will refresh Senate staff on FDA’s enormous and diverse responsibilities, its many successes, and its growing resource needs to fulfill its mission. Our key points are here.

We are scheduling virtual meetings across two days — May 25 and 26. We are looking for participants who can be available at any time between 9:00 a.m. and 5:00 p.m. ET on those days. While two-hour and half-day availability helps the most, we may have a need to fill out teams for single meetings. So, please let us know if you expect to have time for Hill Day, even if you cannot yet be certain when on each day. For more information and to sign up, please contact Reed Diskey.

Upcoming Alliance Webinars — Don’t Miss Any of Them. We continue to invite FDA leadership to address the Alliance membership and media. Last month’s webinar with Acting Commissioner Janet Woodcock was an enormous success — more than 200 participants and at least 15 reporters filed stories. The video is here and the transcript is here. We have two more such meetings scheduled and will announce more in the future:

  • CDER Director Cavazzoni. For Alliance members and media: please join us for a virtual presentation by newly-permanent CDER Director, Dr. Patrizia Cavazzoni on May 25 from 3:00 to 4:00 PM ET Dr. Cavazzoni will discuss CDER’s priorities and resource needs, as well as data modernization, regulatory science, and product safety. To sign up, please register here.
  • FDA’s Food and Animal Health Leadership. For Alliance members and media: please join us for a virtual presentation on June 8 from 2:00 to 3:00 PM ET by Deputy Commissioner for Food Policy and Response Frank Yiannas, CFSAN Director Susan Mayne, and CVM Director Steven Solomon. They will discuss priorities and resource needs, including the New Era of Smarter Food Safety, the Food Safety Modernization Act, and One Health initiatives. To sign up, please register here.

If you are not an Alliance member and want to participate, please contact Steven Grossman to be our guest at these special events.

Survey Says: AI Expected to Supplant Telehealth as Top Health Investment Priority. In a survey of the priorities of 3,000 healthcare leaders worldwide (here),

investing in predictive technology like AI and machine learning jumps up the [investment priority] list, with 80% of U.S. respondents saying it will be a top priority by 2024. Countries with emerging economies like Saudi Arabia, India, and Russia will prioritize AI investment the most in three years, with 98%, 94%, and 85% of respondents, respectively, saying it’s a priority.

This supports the need for FDA to invest heavily in its capability to evaluate products using AI, as well as strengthening its ability to integrate such tools into its own work. This is described further below and in this week’s Analysis and Commentary.

FDA’s Technology and Data Modernization Needs: Challenge and Opportunity. The Alliance has prioritized funding and implementation of the FDA’s Technology Modernization Action Plan (TMAP) and the Data Modernization Action Plan (DMAP). This was validated and expanded upon by Acting Commissioner Woodcock’s remarks to the Alliance on April 14. While we cannot be certain, there is a good chance that FDA’s FY 22 budget request will include monies for technology and data modernization, as well as integration of AI and other emerging technologies.

This week’s Analysis and Commentary looks at Dr. Woodcock’s remarks from April (on data modernization) and FDA’s FY 21 budget request from last year (on use of AI and other emerging technologies). Both sources provide valuable insights but are not necessarily predictive of what will be requested this year.

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