Advocacy at a Glance

Reminder to Media: Friday Updates (comprising "Advocacy at a Glance" and "Analysis and Commentary") is on-the-record. Further, we are always available to both our members and media to answer additional questions.Top-Line: The House completed action on the FY 21 Ag/FDA appropriations bill, in which FDA would receive a $41 million increase. The next step would involve Senate mark-ups, which could be in September, but are more likely to be post-Election Day. This week’s Analysis and Commentary has another series of Q&As that clarify aspects of the current funding situation, overall and for FDA.House Appropriations Minibus Containing FY 21 Ag/FDA Funding Advances. Sometime today (July 24), the House will pass the first minibus package (H.R. 7608) that contains four appropriations bill, including Ag/FDA. Overall, there were few changes from Committee-reported bills and none affected FDA funding. The proposed FDA budget authority (BA) appropriations in the House-passed bill is $3.212 billion in discretionary funding, an increase of $40.8 million above the 2020 enacted level. A description of the purposes for which the additional monies are intended, along with the Alliance’s response statement can be found here.House Passes FDA Amendments that Reflect Priorities, Leave Dollars Unchanged. The Appropriations process in the House allows amendments that increase a program by a certain amount and then simultaneously decrease it by an equal amount. These are similar in effect to floor colloquies. Three such non-binding FDA-related amendments passed as part H.R. 7608. They support FDA efforts to: (1) further implement the Food and Veterinary Medicine Program Strategic Plan to enhance the security and reliability of U.S. supply chains during COVID-19 for food, pharmaceuticals, and other essential medical equipment and supplies; and (2) enforce dairy standards of identity. There is a third one concerning CDER for which we don’t yet have details, but which would also be non-binding.Senate Unlikely to Move on Appropriations, Despite House Votes. The Senate is now enmeshed in considering the next pandemic-economic support legislation. That is expected to take 2 to 3 weeks and the Senate will adjourn for its August recess once that is completed. Prospects for Senate action on appropriations in September are poor and, most likely, the government (including FDA) will be funded under a Continuing Resolution until after Election Day. This was discussed at length in last week’s Analysis and Commentary and confirmed by a Roll Call analysis this week.Continuous Pharmaceutical Manufacturing Gets New Focus. On July 15, the House Energy and Commerce Committee marked up and reported H.R. 4866, a bill sponsored by Committee Chairman Frank Pallone. The bill would provide for the creation of National Centers of Excellence in Continuous Pharmaceutical Manufacturing. The bill significantly broadens and upgrades a much smaller, narrower program that was created by the 21st Century Cures Act.Public Hearing Slated on FDA Hiring and Retention Assessment. FDA has scheduled a virtual hearing on July 30 to review and receive comments on the report “FDA Hiring and Retention Interim Assessment.” Details on the hearing and links to the report and other relevant documents are here.