Deteriorating Situation at Shut-Down FDA, Despite Commissioner Gottlieb’s Best Efforts
Deteriorating Situation at Shut-Down FDA, Despite Commissioner Gottlieb’s Best Efforts. At week’s end, FDA has made food safety one of its priorities by investigating outbreaks, carrying out recalls, and continuing to inspect food imports during the shutdown. Commissioner Gottlieb was successful in getting permission to recall enough inspectors to handle high-risk inspections. Nonetheless, the agency is still thinly staffed on the food side and needs the capacity to resume routine food safety inspections, which ensure Americans’ safety and bolster their confidence in our food supply.On the medical products side, the agency has retained front-line personnel, somewhat parallel to the food situation, by continuing: post-market surveillance, recalls and non-routine inspections. In addition, FY 18 carryover user fees are available and have allowed the continuation of many medical product review activities (for more details (see the Alliance’s FDA Shutdown Toolkit). However, the carryover funds available are limited and FDA is using triage and cash management techniques to preserve funds for the most critical product- and safety-related services. Although nothing definitive has been said by the agency, it seems unavoidable that this will create delays in medical product reviews and could affect review deadlines. We know that Dr. Gottlieb has been focused on preserving as much as possible of the user fee-set procedures and timelines at CDER, CBER, and CDRH.Today’s Analysis and Commentary explores who are “essential personnel” in a shutdown, will OMB soften the rules for services that most impact Americans, and other questions we are being asked.
House Passes Stand-Alone Appropriations Bills at Senate Levels. On January 3, the House passed an omnibus appropriations bill that would fund all of the agencies affected by the shutdown. To exert additional pressure on the Senate to vote, the House bill used the appropriations levels that had previously passed the Senate. This week, the House continued this strategy, voting on each of the four appropriations bills separately and at the Senate-passed levels. On January 10, the House passed H.R. 265, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019. No action is expected in the Senate at this time. However, should the shutdown impasse get resolved, the Senate would be in a position to quickly fund and re-open the government.
First Round of FY 2020 Appropriations Meetings: Join Us. The Alliance meets with Hill staff year-round. Traditionally, our first outreach of the year is in early February when we talk with the personal staff of members of the House and Senate Ag/FDA Appropriations subcommittees. We will start these FY 2020 cycle meetings on February 13. If you are available for a half day -- either morning or afternoon -- to help, we would appreciate your participation. Let Samantha Beard know you are available.
Senate Ag/FDA Appropriations Subcommittee Leadership Announced. The Senate Appropriations Committee has announced that the Ag/FDA subcommittee will again be chaired by Senator John Hoeven (R-ND). The ranking member will continue to be Senator Jeff Merkley (D-Ore).