Advocacy at a Glance

Top-Line: CDRH Director, Dr. Jeff Shuren’s remarks at an Alliance webinar are summarized in this week’s Analysis and Commentary. The Alliance joined other advocacy organizations in urging Congress to increase funding for key public health agencies (including FDA). Congress must come to some resolution of FY 21 funding before December 11. Representative Rosa DeLauro is elected chair of the House Appropriations Committee for the 117th Congress.CDRH Director Presents at Alliance Webinar. The CDRH director, Dr. Jeffrey Shuren, presented at an Alliance webinar on December 3. His remarks are summarized in this week’s Analysis and Commentary and also received an excellent write-up in RAPS' Regulatory Focus publication (here).Alliance Joins Research!America Letter Urging Substantially Increased Funding of Public Health Agencies. The Alliance signed onto a Congressional letter (here) organized by Alliance member, Research!America. A number of Alliance members signed on, as well. The letter urges Congress to increase FY 21 funding for NIH, CDC, FDA, AHRQ, and NSF, stating

the significance of these research and public health agencies has never been more apparent; their works saves lives, fuels solutions for societal challenges; creates jobs; and contributes in multi-faced ways to individual and national security.

The letter asks for $2 billion more for NIH; $380 million more for CDC; and $250 million more for FDA.Appropriations: Compromises Difficult in September May Be No Easier in December. The current Continuing Resolution runs through December 11, at which point there are three options: (1) action on funding bills has to be completed, or (2) another short term CR passed to allow additional time to finish the FY 21 package, or (3) a longer-term CR will be adopted to take us into a new Congress and Administration in 2021. It is hard to imagine that even the easier 10 appropriations bills could pass Congress and be signed by the President by next Friday. However, the Appropriations Committees have a track record of being able to resolve and move legislation quickly. It also is possible that COVID-19-related relief legislation may move forward as part of the FY 21 appropriations package -- each may make the other more likely to pass.If the Ag/FDA funding bill becomes law -- either as stand-alone or more likely as part of an omnibus -- the agency is most likely to get about a $40 million increase. With a few slight differences, this is the number in the Administration request for FY 21 and the House and Senate bills. The likely distribution of those funds is discussed in a recent Analysis and Commentary (here).Representative Rosa DeLauro to Chair House Appropriations Committee. Representative DeLauro of Connecticut has been elected to chair the House Appropriations Committee in the 117th Congress, succeeding Representative Nita Lowey of New York, who is retiring. Representative Kay Granger of Texas will continue as the ranking member of the full committee. Given that Representative DeLauro was previously chair of the Ag/FDA Appropriations subcommittee, the Alliance has received press inquiries about what we think of her elevation. We have responded:

Representative Bishop as Ag/FDA subcommittee chair and Representative Fortenberry as ranking member are the keys to FDA support in the House appropriations process. However, there is no down-side to having the full committee chaired by a Member who has been a long-time champion of the agency.

Digital Media RFP Released by Alliance, Bids Are Welcome. The Alliance is seeking assistance in overhauling its website and improving its digital media visibility. Accordingly, the Alliance released an RFP earlier this week. The deadline for responses is December 30; however, proposals will be reviewed on a rolling basis as they come in. If you are interested in receiving the RFP, please contact Reed Diskey.Alliance 2021 Invoices Sent to Members. By now, every current Alliance member should have received an invoice for their 2021 dues, allowing payment with either 2020 or 2021 funds. If you have not received an invoice, please contact Reed. If you have questions about your invoice or would like to join the Alliance, please contact Steven Grossman.

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CDRH Update and Future Priorities

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Time to Give Thanks -- Once Again