Notes from the Alliance Meeting with CBER Director, Dr. Peter Marks

Topline: We report on the Alliance’s meeting with CBER Director, Dr. Peter Marks, including discussion of the urgent operational challenges brought about by explosive growth in gene therapy development. The FY 21 appropriations process won’t kick off until the President’s February 4 State of the Union address. However, the appropriations committees, as well as the Alliance, are already readying themselves for what could be a fast start on appropriations bills.Notes from the Alliance Meeting with CBER Director, Dr. Peter Marks. Fifteen Alliance members plus Alliance staff met this week at White Oak with Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research. He was very forthcoming in reviewing the opportunities, challenges and priorities at CBER. These are described in more detail in this week’s Analysis and Commentary and in Dr. Marks’ hand-outs.What stood out most were staffing issues, particularly related to the unexpectedly rapid acceleration in gene therapy products that need feedback and review (900 active Investigational New Drug applications -- INDs -- and more than 200 new ones coming in each year). The need for integrated information technology systems also came up several times (FDA has a number of legacy systems that are siloed from each other). Because Dr. Marks stressed the importance of a scientifically-trained workforce, readers may also want to review our January 10 Analysis and Commentary, entitled "FDA Is Its People".Appropriations Process on Hold Until State of the Union and Release of the Budget-in-Detail. The first public step of the FY 21 appropriations process will be the State of the Union (SOTU) on February 4, which will incorporate President Trump's priorities for FY 21 programs. Our understanding is that OMB plans to follow the usual pattern of releasing the President’s FY 21 budget request (the budget-in-detail) on the following Monday, February 10. Subcommittee hearings will probably start soon thereafter, which could be late February or early March. As we noted previously, some slippage or acceleration of these dates might occur for practical or political reasons.Is Anything Going on in DC Besides the Impeachment Trial? These types of events can be mesmerizing and, undoubtedly, many Hill offices have their televisions tuned to CSPAN or one of the cable news networks. Appropriations staffers may take a peek at the TV, but we feel certain they are busy preparing for the upcoming FY 21 appropriations cycle. We already know that senior appropriators have vowed not to let “other business” (such as the trial) delay completion of the FY 21 appropriations process.Our Hill Day, Your Hill Day: Both Are Important. The Alliance’s Hill Day will be Wednesday, March 18. Please mark your calendars and sign up by contacting Reed Diskey. 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.Many of our Alliance members also hold their own Hill days and we encourage you to include FDA’s increased funding needs among your “asks.” If you plan to do so, let us know the date and your needs (a one-pager, a paragraph, a chart, etc.) and we will be happy to support your efforts with regard to FDA funding. To follow-up on this, please contact Elizabeth Stower.Upcoming Alliance Member-Only Activities; Just a Few Slots Remain. Having completed our meeting with Dr. Marks of CBER this week, our next meeting is at White Oak on February 4 (afternoon) with Dr. Jeffrey Shuren, Director of CDRH. A few slots remain -- Alliance members only. In the next few weeks, we expect to announce additional Center meetings. On February 12, we have meetings scheduled with staff of members of the House and Senate Agriculture Appropriations Subcommittees and Subcommittee Clerks. Again, a few slots remain -- Alliance members only. The next large event will be the Alliance’s Hill Day, described above. To be considered for either the Shuren or the February Hill meetings, contact Reed Diskey.