As FDA makes coronavirus adjustments, some regulatory approval activities could be disrupted

To contact the author of this analysis, please email Alec Gaffney.

The Food and Drug Administration is suspending in-person meetings, non-essential travel and many external meetings, according to agency communications shared with AgencyIQ.

The Food and Drug Administration is suspending in-person meetings, non-essential travel and many external meetings, according to agency communications shared with AgencyIQ.

“In thinking about what is best for FDA staff, and to ensure FDA maintains its response readiness, effective immediately we are canceling official agency travel through April except mission-critical and COVID-19 response-related travel, and will reassess on an on-going basis for future months,” wrote Jim Sigg, the FDA’s Chief Operating Officer, in an email to FDA staff.

Among the biggest disruptions will be travel related to inspections. All foreign and domestic inspections that are not “mission critical” are set to be postponed until after April 2020. Instead, the FDA said it would increase its use of inspections when products enter the country, as well as cooperative measures with other global regulators. However, it’s unclear to what extent other regulators are postponing the same inspections, which could increase risks to the supply chain.

Immediately, FDA staff are being permitted to telework, and FDA officials said they are “evaluating and actively testing” its IT systems to ensure that a large volume of its staff can tele-work at the same time. Staff are being encouraged to take their laptops home on a daily basis “in case of events that may impact access to their duty station.”

“Meetings are also being postponed, cancelled or reconfigured,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), told staff.

“CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April,” Woodcock wrote in a statement to CDER staff. “To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible.”

What’s Next

The FDA did not explain if all advisory committee meetings are being postponed or cancelled. Already, it has postponed one meeting of the Nonprescription Drugs Advisory Committee and another meeting of the Blood Products Advisory Committee.

Other advisory committee meetings still scheduled include ones meant to consider:

  • the approval of GSK’s Trelegy Ellipt;
  • the approval of Avid Radiopharmaceuticals’ (a subsidiary of Eli Lilly) Alzheimer’s disease positron emission tomography imaging product, flortaucipir F18;
  • ways to reduce the risk of transmission of Zika in the blood supply;
  • the reclassification of facet screws systems, noninvasive bone growth stimulators, semiconstrained toe (metatarsophalangeal) joint prostheses, intracompartmental pressure monitors, and intra-abdominal pressure monitoring devices;

The moratorium on external meetings may make it somewhat difficult for companies to continue to meet with the FDA as part of the regular new product submission process. For example, many companies use pre-submission meetings to answer critical questions about their applications in the hopes of increasing their chances of approval during the first cycle of review. Most of those meetings may soon take place over the phone instead of in person.

“Where possible the agency will leverage technology to host meetings allowing for remote participation,” FDA spokesperson Jeremy Kahn told AgencyIQ.

However, the reductions in inspections could also have a major impact on product approvals. Most products require pre-approval inspections to ensure that the product is able to be safely manufactured.

“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” FDA Commissioner Stephen Hahn wrote in a statement. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government.”

The increased use of telework by agency officials may also negatively affect regulatory capacity. FDA review timelines for product approvals depend on the work of many FDA staffers. For example, the approval of Balversa (erdafitinib) involved 44 individuals on the FDA review team. While most review work can be done remotely, coordination for these large groups may pose a challenge. This loss of efficiency could have ramifications for the timely review for a range of products, including new drugs, generics and other medical products that are currently under review or expected to be submitted shortly.

Some FDA work, such as materials testing, also requires access to laboratory equipment, though it’s unclear how much of that work is considered essential.

As of October 2019, the FDA employed 17,600 full time equivalents, of which about 60% are considered by the FDA to be essential. However, unlike a government shutdown, it seems likely that the outbreak of a virus could cause significantly more staff to be kept home out of an abundance of caution.

Industry impact

Life sciences companies, too, could see their operations affected. As one FDA staffer told AgencyIQ, some companies may find it difficult to submit regulatory applications to the FDA depending on their staffing. Issues faced by the FDA—teleworking capacity and deadlines—are just as likely to be experienced by life sciences companies.

There is also a concern about companies’ ability to maintain ongoing operations, such as drug manufacturing. If workers are sick, they will be unable to conduct their normal duties, including staffing drug manufacturing facilities.

This is a longstanding concern for the FDA. In March 2011, the agency published a draft guidance document for producers of “medically necessary” drug products clarifying how manufacturers can plan for the effects of high absenteeism during a crisis event, such as a pandemic:

“For example, in an influenza pandemic, widespread human outbreaks of illness would be expected in the United States and around the world, resulting in widespread high absenteeism that could hinder normal production activities and cause shortages in the supply of drug products, packaging materials, and drug components. It is therefore vital for industry to prepare before an emergency situation occurs and to develop plans to ensure continuity of operations during emergencies (including, for example, an influenza pandemic, natural disaster, or personnel issue) that would prevent a significant portion of the work force from reporting. It is especially important for manufacturers of finished drug products to be aware of their suppliers’ and contractors’ responses to personnel shortages and, when appropriate, work with them to ensure the availability of high quality materials and services that contribute to the manufacture of [medically-necessary products] MNPs.”

Those plans are a vital safeguard, given that under federal regulations (21 CFR 211.28(d)) persons who are sick “shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products.”

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