Advocacy at a Glance

Top Line: Hill Day with Senate staff on May 25 and 26, with Alliance members invited to participate. The President’s detailed budget now expected to be released on May 27, with public witness statements due in the Senate on May 28 and the House on June 1. Alliance webinars with CDER Director Dr. Patrizia Cavazzoni on May 25, and FDA’s food and animal health leadership on June 8. Alliance members are encouraged to submit testimony to the Appropriations Committees in support of robust funding for FDA.Hill Day Part 2: Meetings with Senate Staff on May 25 and 26. Please Sign Up. While we 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 looking for participants who can be available at any time between 9:00 a.m. and 5:00 p.m. on those days. While two-hour and half-day availability helps the most, we will have a need to fill out teams for single meetings. The goal is to involve the most members possible, while assuring balanced teams of no more than six people, including the team leader. As a result, some volunteers may have only a few meetings, while others may be involved in a larger number. So, please let us know by May 21 if you expect to have time for one or more meetings on our Hill Days. For more information and to sign up, please contact Reed Diskey.President’s Budget Release May 27/Congressional Testimony Due to Appropriations Committees at the End of May. The White House has just announced that the President’s Budget Request will be released on May 27. In the same timeframe, Senate testimony is due on May 28 and House testimony on June 1. The Alliance will submit its comments on why FDA needs robust support and a significant bump in funding in FY 22. We encourage all our Alliance members (and other FDA supporters) to do the same. Details on submitting testimony can be found here and Alliance members seeking assistance should contact Roger Szemraj.The close timing means that we will write our testimony in advance and then make a few last-minute changes. Some Alliance members will want to coordinate with us on changes, while some groups may want to finalize and submit their testimony without reflecting the President’s request. Both approaches are valuable -- having Congress know the breadth of stakeholder support for the FDA is what matters most. To support our members, this week’s Analysis and Commentary provides guidance that Alliance members can customize to reflect their own point of view.Upcoming Alliance Webinars -- Do Not 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 is available in both video and as a transcript. We have two more such meetings scheduled and will be announcing more soon:

• 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 p.m. to 4:00 p.m. 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 p.m. to 3:00 p.m. ET by Deputy Commissioner 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 tenth anniversary of 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.FDA Releases Report on Resiliency in the Inspections Process. One of the many consequences of the pandemic is that FDA had to curtail its inspections of FDA-regulated products and facilities. FDA has now issued a report, looking backward to what happened and setting out its plan and priorities for catching up. The meaning of the report is contextualized by Bloomberg and a summary is available from our colleagues at OFW Law.Alliance Member Frank Sasinowski Honored With Vatican Award. Frank has been a long-time member of the Alliance, as well as one of the most prominent members of the FDA bar in DC. This past Saturday, Pope Francis awarded him with the “2021 Pontifical Hero Award for Inspiration” for his “unwavering advocacy for those who live with rare diseases.” Congratulations to Frank for this incredible and well-deserved honor.