Advocacy at a Glance

Top-Line: Congress continues to work on a bill that includes both FY 21 appropriations and a COVID-19 relief package. FDA benefits if a funding bill passes, rather than a CR. This week’s Analysis and Commentary looks at how the potential $40 million increase in agency funding is to be allocated. Innovation and FDA expertise are a match that is needed for progress in medical products and food.House-Senate Near Completion of Combo Appropriations/COVID-19 Relief Bill. As of press time Friday morning (December 18), the following are true:

• The appropriations and COVID-19 negotiations are well-advanced and there is widespread optimism.
• As negotiators get closer to a final agreement, the last few remaining issues are the most difficult to resolve, which is reason for pessimism.
• Congress will likely not pass another short-term CR, preferring to vote this weekend and keep pressure on the negotiators.

Without another short-term CR, the federal government will go into shutdown mode at midnight on December 18. Fortunately, most government employees who work on Saturday and Sunday are in categories exempt from a shutdown. As a result, the real deadline for Congressional action is probably about 3:00 a.m. on Monday or whatever time OPM must provide direction to the federal workforce before they head to their offices.

Continuing Resolution vs. Omnibus Legislation: How Does FDA Fare? If negotiators fail to pass funding bills, the most likely outcome would be a CR that runs through February or, possibly, until the end of the fiscal year. If that occurs, FDA will be able to keep spending, but at the FY 20 level. This might affect new initiatives and programming and personnel planning. If the Ag/FDA appropriations bill becomes law—either as a stand-alone or more likely as part of an omnibus—the agency is most likely to get about a $40 million increase. This week’s Analysis and Commentary describes the projects most likely to be funded if the agency receives that amount of new funding.

Innovation and FDA: The Need to Support and Expand Expertise. FDA needs to constantly expand its expertise to keep pace with the increasing sophistication of the products and processes being advanced for the agency’s review. For example, FDA cannot knowledgeably evaluate products based on artificial intelligence without having its own AI experts on staff. The same could be said of cell and gene therapies, where additional reviewers are needed in the face of hundreds of IND’s in this specialized area. This week’s example comes from the Center for Veterinary Medicine and its Veterinary Innovation Program. FDA announced, in Dr. Hahn’s words:

the first ever approval of an animal biotechnology product for both food and as a potential source for biomedical use.

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 month. The deadline for responses is December 30. 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.  
 
The Friday Update will not be published on December 25 and January 1. We will be back on Friday, January 8, 2021. In the interim, Alliance staff will be working and available if you have questions or if we can be of service to you.