The FDA is keeping its biologics labs shuttered far longer than other government research labs, according to internal FDA documents obtained by STAT.
FDA officials told staff last month that it will keep the labs, which research ways to improve the safety of existing vaccines and gene therapies, closed until there are fewer than 10 coronavirus cases per 100,000 people in the counties surrounding the agency’s White Oak, Md., campus. Currently, just 16 states meet that metric.
That stands in stark contrast to the reopening guidelines at other federal research labs in the Washington area. The National Institutes of Health, for example, let many of its researchers back into their labs in June and July.
Ashish Jha, faculty director of the Harvard Global Health Institute, suggested the biologics’ lab plan was unnecessarily restrictive, even given the public health concerns associated with the spread of the coronavirus.
“These are scientists: They are going to be compliant. I believe that with good masking, reasonable ventilation, unless you’re in the super hottest of the hot zones you can probably open labs up safely and get people working on critical issues,” said Jha. “You’ve gotta open up labs, you have to let scientists get back in again.”
Jha, who created the metrics the FDA adopted for its reopening standards, said he was surprised to learn the labs were currently shuttered.
One of the scientists who works in the labs said they and their colleagues are frustrated by the closures.
“The prolonged shutdown of many labs implies that our research and our researchers are ‘non-essential,’ and that’s distressing – not to mention demoralizing,” said the FDA scientist who runs one of the shuttered FDA labs and who requested anonymity because they are not authorized to talk to reporters. “Many of our lab-based people are really eager to get back to the bench, of course incorporating new safety practices. We just want to make a contribution to protecting the public health.”
The FDA’s reluctance to open labs underscores the lasting impact that the coronavirus will have on the progress of science for years to come. FDA’s biologics center conducts experiments focused on improving the safety of biologic products, like vaccines and gene therapies. Labs in FDA’s biologics center are currently studying new ways to detect potentially deadly pathogens in blood donations; design safer gene therapy vectors; and improve vaccines for anthrax.
Jesse Goodman, who led the FDA’s biologics center from 2003 to 2009, emphasized that not only does the FDA’s research help the agency better understand how to regulate biologic products, like vaccines, it helps speed the development of those products. Goodman told STAT he once contemplated the possibility of cutting the budget of the biologic labs, early in his tenure as director, but quickly thought better of it after seeing the impact of the work the labs do.
“I ended up feeling that it’s a very good investment, and that it was underinvested in, in fact,” Goodman said. “I was impressed by the niche that FDA research could fill.”
FDA’s decision is unlikely to impact the agency’s work on Covid-19 vaccines: FDA scientists working on Covid-19-related experiments can request exemptions from the reopening policy.
The FDA’s strikingly restrictive approach toward reopening the biologics labs comes as the FDA, more generally, is beginning to reopen its Maryland campus.
FDA began its “Return2Facilities” campaign on Aug. 3, FDA Commissioner Stephen Hahn announced in an FDA-wide email on July 30, which was obtained by STAT. Under the new plan, FDA employees can volunteer to return to in-person work on FDA’s campus, subject to supervisor approval.
“The effort is a culmination of months of detailed planning that includes prudent precautions to continue to keep employees working at FDA facilities as safe as possible,” Hahn wrote.
The FDA did not answer most of STAT’s questions about the reopening plan, but in a statement it explained why the FDA was opening some of its facilities, while keeping certain labs closed.
“Our laboratory spaces are unique workspaces that required some additional planning and preparation for returning to onsite work in as safe a manner as possible,” the statement said.
While the FDA writ large encourages staff to come back to work, biologics labs aren’t able to open until the counties around Washington, D.C., have a seven-day rolling average of new cases below 9 per every 100,000 people.
Those figures are based on metrics from the Harvard Global Health Institute, which ranks a community’s “Covid risk level” based on how many cases of Covid-19 are detected per 100,000 people. Jha, the Harvard doctor who created the metrics, said a community with that rate of transmission could likely open up schools safely. Any prevalence above 9 out of 100,000 is considered “accelerated spread.”
The spokesperson did not confirm nor deny the metric being used by biologics labs.
Jha predicted the D.C. area may not meet the FDA biologics labs’ metric “for months, if not for the rest of the pandemic.”
“I’m not at all sure that they’re going to [meet that metric] any time super soon unless there’s real policy action,” Jha said. “I don’t think that I would have picked a hard target like this.”
When asked to confirm the metrics being used by his center,Peter Marks, director of FDA’s biologics center, told STAT that the centers’ reopening policies are being continually reevaluated.
“We have not yet expanded laboratory operations, though we continue to do essential work in our laboratories for things like influenza and COVID-19,” Marks said. “Given the epidemiology of an upward slope in cases in Maryland recently, as well as the limitation [placed] on the need for social distancing in our labs, we choose not to expand operations just yet, though we will reevaluate continually, and indeed our criteria will evolve, as appropriate.”
The FDA’s reopening guidelines are strikingly different from the policies at the National Institutes of Health.
The NIH’s Maryland campus shut down in March but most bench scientists are already back at work, according to NIH spokesperson Renate Myles. Some never stopped working — their work was deemed “mission critical,” meaning they could remain on campus while it was closed.
The NIH has since moved through two “phases” of reopening, which brought more lab workers back on campus. The NIH began its group A, which covers “work that cannot be done remotely,” on June 22 and group B, which covers “work that is difficult to complete remotely,” on July 20.
The likely reason for a large portion of NIH bench scientists getting back in the lab: The agency is using different metrics for deciding when to reopen.
Myles told STAT that the agency is monitoring five to seven days of Covid-19 community spread when determining whether to bring additional groups back on campus. The agency, however, is not using a hard metric like the Harvard metric.