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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.

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.”

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.

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.

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