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# Inspections Top Priority After Pandemic: Woodcock
- URL: https://www.fdaweb.com/inspections-top-priority-after-pandemic-woodcock/
- Published: 2021-04-14T12:00:00.000Z
- Updated: 2026-09-14T16:54:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149113

*\[Report by David McFarland\]* As FDA looks ahead to life after the pandemic, recovery phase planning is already underway to prioritize facility surveillance and inspections. Speaking on a 4/14 Alliance for a Stronger FDA Zoom update, acting FDA commissioner **Janet Woodcock** said surveillance and inspections will be boosted by part of the additional $500 million allotted to FDA under the recent Covid-19 stimulus measure.

Last month, the Government Accountability Office (GAO) said FDA needs to use lessons it has learned during the Covid-19 pandemic to improve its foreign drug inspection program, including efforts to identify alternative mechanisms to satisfy foreign inspection requirements and ways to address its growing backlog of inspections. In [testimony](https://www.gao.gov/assets/720/712761.pdf?ref=fdaweb.com) before the House Appropriations Committee subcommittee that oversees FDA, GAO healthcare director **Mary Denigan-Macauley** said her organization found in 12/2019 that FDA faced many of the same challenges overseeing foreign establishments that were identified over the last two decades. “Subsequently, the outbreak of Covid-19 has added a layer of complexity,” she said.

Denigan-Macauley testified that FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused due to the pandemic. Such tools, her testimony said, include relying on inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs. FDA 4/14 released a [guidance](https://downloads.regulations.gov/FDA-2020-D-1136-0057/attachment%5F1.pdf?ref=fdaweb.com) describing how the agency will request and conduct remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring program; and outsourcing facilities during the Covid-19 public health emergency.

In her Zoom update with the Alliance, Woodcock said that the $500 million supplemental appropriation will also fund continued pre-market work, such as increasing emergency use authorization work. “Obviously, more interventions are continuing to be tested,” she said. “We also are going to invest in the supply chain. One of the things that this pandemic made very, very clear is that we don't have enough insight and visibility into various supply chains. We have received some monies to do this, but we have received additional within this supplemental,... and we plan to invest in advanced manufacturing, which also has to do with \[drug\] shortages and the need for surge capacity...”

During the update, Woodcock was asked to comment on concerns based on a recent spate of review delays and complete response letter issuance ([see earlier story](https://www.fdaweb.com/fda-dismisses-concerns-about-whether-approval-bar-raised/)) that FDA is less flexible than previously and may have raised the bar on drug approvals. She said she did not believe that the agency is taking a more stringent approach to reviews or exercising less flexibility than in the past. Woodcock said that what is happening is that science and drug development are “moving into fields that typically haven't seen the kind of advances that we’ve seen in other areas, like cancer. And so I think there is some adjustment that has to be made as people deal with it.”

 Woodcock recommended that those sponsors who believe the approval bar has been raised need to talk to CDER and Office of New Drugs (OND) management. She mentioned that just as the pandemic broke out OND was working to finish its planned reorganization. “So I think they’re cranking out a lot of work and so forth, but I think that that made it very difficult to get that organization to be a coherent fully staffed organization because it finished growing up during a worldwide unprecedented pandemic,” she explained. “So I wouldn't read too much into the tea leaves over this but I do think it’s worth, for those who are interested, having more conversations with the Center for Drugs.”

 Asked about long-term budget priorities, Woodcock said FDA needs to keep up with its obligations, and to have adequate funding to conduct those, including modernization efforts. She said the basic long-term modernization plan is to move legacy systems to enterprise-wide platforms and common data standards so FDA’s systems can talk to one another. The legacy systems cost a “tremendous amount” in maintenance, she said, adding that the planned enterprise-wide platforms will use available off-the-shelf software and then transition processes in databases onto cloud forms.

“So with modern computing, you don't need to have the exact same system doing everything,” Woodcock continued, “and they can talk to each other as long as the data are somewhat compatible... So, we have just kicked this off formally and I was at the first meeting of the Data Council and the good news, from my point of view organizationally, is that everyone gets this... We have a method to move forward now and everybody sees the fact that we can’t continue the way we’ve been doing.”

As to how different FDA will look five years from now, Woodcock said the agency will see increased scientific sophistication and increased use of information and data. “Hopefully, we can move most of our things to the cloud and automate many tasks so our scientists and other staff are working on things where they really can contribute and they don't have to do a lot of busy work,” she said.

Woodcock also told the Alliance that the cell and gene therapies program has one of the most pressing resource needs because the field is poised to explode. “We hope so, because people with rare diseases and genetic diseases, and some cancers, will probably benefit tremendously from this field,” she said. This program is more complex than traditional drug programs and will require a significant increase in the workforce to have the same level or even a slightly higher level of oversight given their complexities amd manufacturing issues, she said.

Asked to characterize agency morale, Woodcock told the Alliance that a November 2020 federal survey found that staff had extremely high morale. “So the fact that during a crisis, people with public health orientations step up to the plate..., and so that we have that kind of esprit de corps,” she said. “I think they’re very proud of what they’ve been able to accomplish, and I am too.”