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Shutdown- and BA-Related Q&As Continued

January 26, 2019

Q. Why does FDA’s headcount seem to shift almost daily, along with frequent changes in what activities are being continued or phased out?
A. What happens during a lapse in appropriations is complex, particularly so at FDA, given its vast responsibilities and multiple funding streams. The key OMB document defines “excepted employees” as normally paid from the appropriation but whose job is necessary to protect public health and safety. “Exempt employees” are those whose work is paid for by funds apart from the budgetary appropriations. Examples would be commissioned corps officers (fully exempt) and those funded by user fees (who may be fully exempt, partially exempt or furloughed, depending on available dollars and priorities). Finally, if an employee is neither excepted nor exempt, then they are furloughed.

Conceptually, the number of fully exempt user fee employees at FDA will decline over time, depending on available funds and the impact of triaging funds to extend activity on the highest-priority programs. At the same time, the number of excepted employees is increasing as “public health and safety” becomes defined more broadly. An example has been Dr. Gottlieb’s success is moving more inspectors from furloughed to excepted status.

Q. Are the House-Senate Conference numbers (+$268 million for FDA in FY 19) likely to prevail when the shutdown ends?
A. Our understanding is that the Ag/FDA appropriations bill and conference report were all-but-finished by mid-December, before the shutdown occurred. Nonetheless, some of the first efforts to break the overall budgetary logjam would have resulted in FDA being funded by Continuing Resolution (explained further here). That would be a particularly bad result for FDA because the CR would have been at the FY 18, bypassing large increases for FDA that were part of both the House and Senate appropriations bills. At the start of the new Congress, the House proposed legislation that would have used the Senate number (+$159 million), rather than their own bill text (+$307 million).

Finally, the House-Senate conference numbers have been released (+$268 million) and the latest batch of bills have been incorporating the conference numbers. With the shutdown continuing, there is no guessing what the final result will be. However, the fact that House and Senate bills — both Republican and Democratic — are incorporating  the conference numbers is encouraging.

Q. Once we are past the shutdown and the FY 19 cycle, what are the prospects for a smooth FY 20?
A. Congress passed the Budget Control Act of 2011 to constrain discretionary federal spending over the following decade. Later negotiations have altered, or bypassed, caps in a number of years. Notably, FY 18 and FY 19 had higher ceiling caps than in law. FY 20 and FY 21 are not covered by any such arrangement. Based on FY 19 spending levels, meeting the FY 20 caps would require Congress to spend $71 billion less on defense programs and $54 billion less on non-defense programs. So, there is every reason to the think the FY 20 process will be contentious.

Advocacy at a Glance

January 26, 2019

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!

The Shutdown: Media Snippets and Commentary

January 18, 2019

The New York Times
Government Shutdown Curtails F.D.A. Food Inspections

“We have a deep concern about those employees who were furloughed, their inability to fulfill their public health functions, and the tremendous personal impact that it has on them,”said Ladd Wiley, executive director of the Alliance for a Stronger F.D.A., a nonprofit advocacy group. “We are also grateful to the roughly 10,000 employees who are retained and working.”

But Mr. Wiley added, his organization also was concerned about nonemergency functions that the F.D.A. has had to put aside. Among the important work being delayed right now, he noted, are manufacturing inspections, technical assistance and advice to the produce industry — especially guidance for preventing contamination — and activity related to food additives.

“There is a whole list of things that are not getting done,” he said.

The Washington Post
FDA directs dwindling resources toward reviewing new drugs

Ladd Wiley, executive director of the Alliance for a Stronger FDA, an industry and consumer advocacy group, agreed that “there’s no easy way for the FDA to quickly make up lost time.”

Medical Design & Outsourcing
FDA adds back some workers during partial government shutdown

No one from FDA was available for further comment on the agency’s work during the shutdown, but an official from the Alliance for a Stronger FDA said that the agency has constantly been evaluating what it needs to prioritize as the shutdown drags on.

About 50% of device reviews are paid for by user fees, and those are continuing during the shutdown because they’re on a separate funding track from the rest of the FDA, said Steven Grossman, deputy executive director of the alliance, an organization of patient groups, consumer advocates, biomedical research advocates, health professionals and industry representatives. FDA surveillance staff is tracking medtech company recalls and will call agency staffers abck to work in the event of a serious recall, Grossman added.

The alliance is also updating an FDA shutdown toolkin on its website because of members’ ongoing concerns.

“I think Dr. Gottlieb and his crew are doing absolutely the best job, and doing this iterative process is the best way to be sure that the American public is safe,” Grossman said.

Bloomberg Law
FDA Hiring of Scientists Hampered by Government Shutdown

Steven A. Grossman, of the Alliance for a Stronger FDA, said the agency “undoubtedly” loses recruits at an early stage, particularly in more specified fields that are already highly competitive for new talent.

New Food Economy
From the farm bill to grocery bills, the government shutdown is affecting how America eats

In a primer first reported by Food Safety News, Alliance for a Stronger FDA (ASFDA), a nonprofit advocate, explained that the shutdown may significantly affect oversight of the food supply. During the current “lapse period,” ASFDA wrote, the Food and Drug Administration (FDA) will be hobbled, though still able to perform “activities necessary to address imminent threats to the safety of human life.”

According to the document, 41 percent of FDA’s employees will be furloughed (about 7,000 people). While the agency’s most critical public health responsibilities won’t be affected — with staff on hand to handle key duties like emergency inspections and drug shortages — other, more routine work will be suspended. That could cause issues.

“Food safety will be particularly hard-hit, including the furloughing of workers in charge of routine inspections,” according to the document, though FDA will still be staffed to handle urgent and high-risk recalls and outbreaks of foodborne illness.

Mass Live
Federal shutdown stops FDA inspections, not production, with USDA still on the job

A nonprofit advocacy group, Alliance for a Stronger FDA, raised concerns about the lack of FDA inspections earlier this week. The partial government shutdown has left 800,000 employees furloughed or working without pay across multiple federal agencies.

Xconomy
Uncertainty grows for biotech as government, FDA shutdown drags on

On Jan. 7, the Alliance for a Stronger FDA assessed the possible impact for companies in its “shutdown toolkit”. Here are some of the highlights:

“Those companies that have filed and paid the product user fee at the time of a regulatory filing and prior to the shutdown, can expect FDA to continue the agency’s review.”

“We believe that while reviews will continue, there is a risk that agency timeframes may slip because review teams are smaller and some ancillary services may be missing.”

“Our understanding from past shutdown threats is that user fee monies will be prioritized to later stage projects — closer to benefitting patients –and then on to earlier stage products.”

“We do not know where the precise lines are being drawn in every instance and cannot provide assurance that any given user-fee funded activity will be fully continued (or partly continued or not continued) during a shutdown.”

The Alternative Daily
Food Safety Threatened by Government Shutdown

According to Wayne Pines, Vice President of the Association for a Stronger FDA, “The FDA regulates products that make up twenty percent of consumer spending. Despite that, forty percent of FDA’s workforce has been shut down because of an unrelated issue in an appropriations bill that doesn’t involve FDA. The Alliance will now redouble our efforts to make sure that policymakers and the public understand the FDA provides public health services that are core functions of government. When FDA is unable to perform them, the public is at unnecessary risk.”

Nature
Scientists despair as US government shutdown drags on

If the shutdown continues for long enough, the agency could be forced to send more workers home, says Ladd Wiley, executive director of the Alliance for a Stronger FDA in Silver Spring, Maryland. “We’re moving into fairly unprecedented territory if this goes beyond a couple of weeks,” he says.

POLITICO
Prescription Pulse — January 7th

The agency can continue work considered essential to public health, but that doesn’t mean all public health work continues, explained Steven Grossman, executive deputy director of the Alliance for a Stronger FDA, “When you get past the people who are on the front lines because of an emergency” or near to it, he said, a lot of routine public health work is on hold. Standing down when FDA can’t say “people will die tomorrow” could leave the country more vulnerable to future emergencies, he added.”

MedPage Today
Shutdown Impact: Food Inspections Get Spottier

Steven Grossman, JD, deputy executive director of the Alliance for a Stronger FDA, told MedPage Today what interrupting routine inspections means for consumers. “Farmer Jones gets inspected every second or third year,” he said. “It’s essential, but if it occurs in March instead of January … it’s hard to argue that it’s so immediate that it can’t wait till March,” he said.”

Grossman added, “I think they’re doing a great job with the staff and the responsibilities that they’re allowed to undertake, but inherently if FDA isn’t running at full tilt … it’s a riskier environment than it needs to be.”

The FDA oversees regulation for about 20% of all consumer spending, including food, drugs, dietary supplements, radio-emitting devices, and medical devices, Grossman said, and most of the work employees do is “essential.”

However, in the case of this shutdown, “the standard that’s being applied is not essential, it’s immediacy,’”said Grossman.

“If the absence of you or your job activities creates an immediate threat, you’re asked to come in and work,” he explained.

Grossman used air traffic controllers as a comparison. “Of course, they’re all working is because their absence would pose an immediate threat to public health and safety,” he said.

Advocacy at a Glance

January 18, 2019

Alliance Works to be a Leading Source of Concern on Shutdown.  This week, in lieu of Analysis and Commentary, please click here to find a few of the news headlines and stories, the Alliance has been quoted in.

Call for social media ambassadors: Our Twitter feed is one of our best resources to disseminate information during the Shutdown, if you would like to become a social media ambassador and help us spread our message and the latest news, then please e-mail Samantha Beard to be added to our list of social media ambassadors.

Are you keeping up to date with the latest? If you’d like to be privy to the latest updates from the Alliance, then be sure to follow us on Twitter @strengthenFDA. We are constantly posting the latest news and information pertaining to the Shutdown, the Alliance, and the FDA.

Anna Abram event likely to be impacted by the shutdown. On Tuesday, January 29th, Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis at FDA was scheduled to visit with Alliance members. However, due to the partial government shutdown the likelihood of the event moving forward is slim. We will continue to monitor the situation and will provide a status update once we know more.

Join Us on Feb. 13 for Meetings with FY 2020 Appropriators. On February 13th, the Alliance will be meeting with personal staff of members on the House and Senate Ag/FDA Appropriations subcommittees. If you are available for a half day — either morning or afternoon — to help, e-mail Samantha Beard to RSVP.

Annual Alliance Lobby Day — Mark Your Calendars — March 18. On March 18, 2019, the Alliance will storm the Hill for our Annual Lobby Day.

The Shutdown Continues: More Qs; More As

January 11, 2019

Q.  What distinguishes essential personnel who continue to work from other important people and functions that are furloughed? … READ MORE …

Advocacy at a Glance

January 11, 2019

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. … READ MORE …

Alliance Releases FDA Shutdown Toolkit

January 7, 2019

As indicated last Friday, The Alliance for a Stronger FDA has just released its promised FDA Shutdown Toolkit. … READ MORE