Possible Temporary End to Shutdown Announced.
Possible Temporary End to Shutdown Announced. On Friday afternoon, President Trump announced a possible 3-week halt in the shutdown, allowing he and Congress to work out a deal on border security. Assuming a deal happens, it is unclear how quickly Congress will vote and FDA programs will be restored.
Shutdown Status: Things Are Rough; It has been reported that 95% of CFSAN and 70% of ORA are still furloughed, although we understand from elsewhere that some callbacks continue (e.g., high-risk inspections of compounding facilities). We have also been told that the PDUFA carryover funds will only be available until mid-February and compounding funds are no longer available. There is enough carryover funding for the generics and medical device process for the foreseeable future, but new applications requiring a fee cannot be accepted. This will create a backlog of product reviews once FY 19 funds become available.
House-Senate Conference Agreement Would Boost FDA by $268 Million in FY 19. We have long known that both House and Senate intended FDA to receive a large increase in FY 19. The House had passed a bill that put FDA at +$307 million, while the Senate bill would have given the agency +$159 million. The unknown has been what was in the House-Senate conference agreement.The conference report was released this week and FDA will receive a $268 million increase if (and only if) an FY19 appropriation bill becomes law (not a continuing resolution). Notably, the conference number is about $35 million more than an even split, indicating that FDA enjoys strong support in both the House and Senate. For the most likely outcome, see the answer to the second Q&A in this week’s Analysis and Commentary (below).
Program with Anna Abram to be Rescheduled. Just a reminder, next week’s presentation by the FDA’s Anna Abram will be rescheduled for some time after the shutdown is over.
Commissioner Gottlieb's Tweets; We Have the Details. Dr. Gottlieb has always used Twitter to communicate with FDA stakeholders. During the shutdown, his Twitter feed has become the primary source of information about the agency’s status. To help our members, media and the stakeholder community, we have appended an edited and reorganized version of Dr. Gottlieb’s tweets since just before the shutdown began. We have eliminated non-shutdown information and most repetitive parts. Hopefully, we have captured everything that is immediately relevant. The tweets are now in chronological order and split into three rough categories: programs continuing through the shutdown; programs slowed by the shutdown; and programs that have ceased under the shutdown. The first Q&A in this week's Analysis and Commentary describes why those categories are shifting as the shutdown enters its 35th day.
This week's Analysis and Commentary Contains New FAQ. The three questions cover the shutdown situation, the post-shutdown prospects for FY 19 appropriations, and an early look at funding issues in FY 2020.
New Appointments on the House Senate Ag/FDA Subcommittee. The House Ag/FDA subcommittee announced that Sanford Bishop, Jr. (D-GA) will be the new chair and Jeff Fortenberry (R-NE) the new ranking minority member. New additions to the subcommittee are Reps. Barbara Lee (D-Calif.), Betty McCollum (D-Minn.), and Henry Cuellar (D-Texas).
Be Part of the Alliance’s Social Media Action Squad! The Alliance is increasingly using our Twitter handle, @StrengthenFDA, to broadcast our concern for FDA and its critical public health responsibilities. Please e-mail Samantha Beard if you are interested in helping. Samantha will send e-mail alerts when there are important Alliance tweets that need amplifying. Thanks for all the “favorites” and “retweets” that we have received so far!