Advocacy at a Glance

Top Line: The Alliance has a new date for our meeting with Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response and has submitted Congressional testimony on FDA’s FY 21 funding needs. This week's Analysis and Commentary explores how that testimony changed to reflect FDA’s role in responding to the current and future crises. Finally, we look at the Congressional calendar and how FY 21 appropriations might be addressed (below).Rescheduled: Alliance to Meet (Virtually) with FDA Food Safety Leader, Frank Yiannas. The Alliance’s teleconference meeting with Frank Yiannas, MPH, Deputy Commissioner for Food Policy and Response has been rescheduled to April 15, from 1:00 to 2:00 p.m.. This will provide the opportunity for him to discuss budgetary and resource needs for FDA's food safety programs and other current topics. This meeting is open to Alliance members and media. Please e-mail Reed to attend. If you would like to participate, but are not yet an Alliance member, please contact Steven.Alliance Submits House/Senate Testimony on FY 21 Appropriations for FDA.  An important part of the Appropriations cycle is the submission of testimony to the House and Senate Appropriations Committees. Our testimony is here. In most years, we take our “ask” and explanatory statement from Hill Day and it becomes the core of our testimony. This year, a lot happened between the board’s adoption of our ask on February 18 and the testimony deadlines that fall at the end of March (House) and early April (Senate). This week’s Analysis and Commentary looks at how our testimony was refined to cover the topic of funding for FDA’s coronavirus activities. In addition, we created a placeholder for as-yet-to-be-defined funding likely to be needed by FDA to maintain a higher level of readiness post-COVID-19.The Congressional Calendar …. The House and the Senate are scheduled to return to DC the week of April 20 (despite DC having a “stay at home” order in place until April 24). At least for now, Congress’s “pending legislative calendar” is limited to slowing the pandemic and saving the economy. For those two items, Members of Congress are willing, if necessary, to return to DC and spend time on Congressional business. It is unclear how much beyond those two items they are willing to go. Social distancing is a strong impediment to regular business, given that it requires the interactions of 535 people (and staff).  Members have made clear they would rather stay home in their districts. Also, the optics are not good for Congress -- probably a third of whom are high-risk based on age and other factors -- to be congregating in DC while their constituents are sheltering in place.… and the Fate of FY 21 Appropriations. Because of these several constraints on Congressional action, prospects for the FY 21 appropriations process are uncertain. For several weeks, we have been talking about the potential for a “virtual” appropriations process. We imagined the possibility of appropriations subcommittees and committees marking up bills using a videoconferencing application.  Of course, that approach would not work for the House and Senate floor time that would be needed to consider these funding bills.Not surprisingly then, the sentiment around DC is that the Appropriations Committees will decide upon a Continuing Resolution that might extend into a post-election session or might even fund the government through March of next year. However, to our knowledge, neither Senate Chairman Shelby nor House Chairman Lowey has given any indication that they will seek CR funding for the first portion of FY 21. So, discussion of a CR must be labeled as speculative at this point. In the end, the decision will be made by the House and Senate leadership working with the leadership of the Appropriations Committees.Miscellaneous Items that We Intended to Cover.  Over the last 6 weeks, we have accumulated items that deserved mention ... but were squeezed out by more pressing news. They are a reminder that even in the midst of a pandemic emergency, FDA must still fulfill the rest of its responsibilities, as well as plan for a strong and effective FDA when the crisis has passed. With that perspective, here are two items that caught our attention:

• On February 13, FDA/CFSAN published the completed Food Safety Modernization Act (FSMA) final rule on intentional adulteration of  food, which covers acts of terrorism and other actions intended to cause wide-spread harm through the food supply (text, summary).
• FDA/CBER held a workshop on March 3 to explore the development of medical treatments that would be tailored to just one or a handful of patients. Among other things, this challenges many of the traditional elements of clinical trials by which FDA can determine whether a product is helping patients (FDA meeting materials, news story on the workshop).