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Advocacy at a Glance

February 21, 2020

Alliance FY 21 “Ask” Set at $120 million above the FY 20 BA Appropriation. The Alliance’s Board of Directors met this week and set the Alliance’s FY 21 budget authority (BA) funding “ask” at $120 million above the FY 20 level for such FDA programs. This would bring the total for Salaries and Expenses (S&E) to $3.278 billion. These numbers do not include $70 million in Cures funding, which comes from savings in mandated programs and is not BA funding. Our numbers conform to OMB budget tables (see attached Alliance chart) but are not the “headline” numbers in the Administration’s summaries.

The Alliance’s “ask” will be used in replying to Congressional requests and is one of the major messages of our March 18 Hill Day. Alliance members and other public health groups also use our numbers in their advocacy on federal funding. Typically, our “ask” is justified by a brief description of what the Alliance regards as funding priorities.  So our document can reflect the breadth of our membership, Alliance members (only) are encouraged to forward their priorities for increased FDA funding to Steven by no later than noon on Wednesday, February 26.  For now, please send us brief points rather than long explanations or documentation.

It All Leads Up to Alliance Hill Day: Join Us on March 18. The Alliance’s most important member activity is our annual Hill Day. This year it will be on Wednesday, March 18. We are seeking to have at least 60 Alliance participants (more would be much better). We will be setting up at least 60 meetings on Capitol Hill (more is likely). This is the day to let Congress know why your organization supports a strong, well-funded FDA and, also, promote understanding of FDA’s far-reaching mission and responsibility. Unlike other Alliance events that are restricted to members, we welcome all FDA advocates to join us for Hill Day. Please mark your calendars and let Reed know if you will be available all day or only in the morning or afternoon. For more information about the Alliance, its activities, or how to join, contact Steven.

Just one additional note: Hill Day will be our fifth member activity of the year. This is an especially tough budget year and we know the Alliance will have to be ultra-proactive as we seek to increase FDA’s budget. We are pleased that already, one-third of our membership has participated in at least one of the first four.  We continue to seek to engage all of our 150+ members in our activities and we welcome any ideas you may have for further participation. And we are especially seeking a big and enthusiastic turn-out on March 18.

FDA Principal Deputy, Dr. Amy Abernethy Tells Alliance About FDA’s Technology Modernization Plans. On an Alliance-sponsored, members-only webinar this week, FDA’s Principal Deputy Commissioner and Acting Chief Information officer, Dr. Amy Abernethy, spoke about the Technology Modernization Action Plan (TMAP) released by FDA this past September. A summary of her comments are contained in this week’s Analysis and Commentary.

As part of FDA’s efforts, the agency will be holding a public meeting on March 27 to discuss possible agency-level approaches to modernizing FDA’s data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics. For more details on attending (in-person or via the web) and for information on submitting comments, please go here.

Enforcement Action in India Illustrates FDA’s Global Responsibilities. FDA’s mission requires it to work far beyond the boundaries of the United States. Globalization of products and source materials is one of FDA’s greatest challenges and one of the reasons why the FDA’s budget must continue to grow. This is illustrated by FDA’s successful bilateral enforcement action with India this week (FDA statement). The work of a joint team of investigators led the government of India to stop approximately 500 U.S.-bound shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices.

Alliance Elects Officers for 2020. The Alliance’s Board of Directors met on February 18 and, among other things, elected officers for 2020. Wayne Pines, President of Healthcare at APCO Worldwide, and Ronald J. Bartek, President and Co-Founder of the Friedreich’s Ataxia Research Alliance, were elected President and Vice President respectively.  Pines is a co-founder of the Alliance and previously served as president. Bartek is a long-time member of the Board.

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