FY23 Appropriations Continuing Resolution; User Fee Status Unchanged

Top-Line

• Appropriations Action in September: Continuing Resolution Likely.

• User Fee Legislation Status Unchanged.

• Just Announced: September 27 Alliance Webinar on “FDA and One Health.”

• Medical Product Inspections Mostly Back on Track.

• Operation Lascar, International Cooperation for Combatting Illicit Medicines.

• Friday Update to Next Publish on September 2.

Analysis and Commentary answers FAQ’s About FY 23 Funding. This is part 2 on this topic, a continuation of last week’s Analysis and Commentary (here).

Appropriations Action in September: Continuing Resolution Likely. The new fiscal year starts on October 1—meaning some action on funding bills is essential, whether appropriations bills or a Continuing Resolution (CR).

 The key to moving the appropriations bills would be agreement on top-line amounts for defense and nondefense spending. Theoretically, there is enough time to reach an agreement and move the bills in September. However, there are no reports of negotiations and commentators seem unanimous in predicting a CR will be required.

This week’s Analysis and Commentary answers FAQs about timing, duration, and consequences of a CR in an election year.

User Fee Legislation: Status Unchanged. The House-passed and the Senate HELP Committee-passed bills both include non-user fee provisions. There is a prevalent view within Congress that House-Senate conferees can work quickly to resolve the differences. Staff is probably working this month to reach agreements on as many provisions as possible. However, there is a dissenting view that the best option is to pass clean user-fee reauthorizations and to address the non-user fee provisions separately and later.

We have seen no reports of negotiations to break the impasse. However, all the Representatives and Senators involved in these negotiations understand the need for timely action. However, the precise deadline is unclear because of the apparent availability of some carryover monies.

Just Announced: September 27 Alliance Webinar on “FDA and One Health.” The Alliance is pleased to announce the first of its fall webinars: September 27, at 11:30 a.m. Register here (this is a corrected date and time from last week’s Friday Update).

“One Health” is an approach to solving health problems by recognizing the interconnection of people, animals, plants, and the environment. FDA is one of many federal agencies that support this approach and encourages its use. The webinar will explain the concept in more detail and feature presentations on how FDA’s work utilizes One Health. Subsequent program announcements will include more on the speakers and agenda.

Medical Product Inspections Mostly Back on Track. The FDA Law Blog reported highlights of a conference on FDA inspections, featuring Douglas Throckmorton, CDER Deputy Director for Regulatory Programs, and Alonza Cruse, the Director of the CDER Office of Pharmaceutical Quality Operations. They reported that inspection of domestic facilities is back to normal and that foreign inspections are likewise normal, except China. So far, Remote Interactive Evaluations have been infrequently used but CDER is preparing to do more of them.  

Operation Lascar, International Cooperation for Combatting Illicit Medicines. This FDA website discusses the focus, past accomplishments, and future plans for Operation Lascar. This is a vehicle for FDA, its regulatory counterparts in the UK and elsewhere to jointly combat illicit medicines. The operation has “revealed how increasingly sophisticated criminal networks were exploiting regulatory, legal, and other gaps to ship and transship…products,” and has been used to support a “range of criminal investigations.”

Friday Update to Next Publish on September 2. We will be taking a week off, skipping the August 26 edition of Friday Update. If there are any breakthroughs on appropriations or user fee legislation before September 2, we will send out a special edition on that.  

While Friday Update will not be publishing again until September 2, Alliance staff will be available if you need information or assistance from us.