FDA postpones meetings and inspections, grounds staff to combat COVID-19
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FDA is postponing meetings, cancelling most travel and halting most foreign inspections as part of U.S. government-wide steps to contain the COVID-19 outbreak.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), told staff in an email Tuesday, “We plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”
Woodcock stressed the need for CDER to “maintain continuity of operations and accomplish as much of our work as possible" while adding that all “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”
FDA postponed a Nonprescription Drugs Advisory Committee meeting that was scheduled to take place Wednesday, and is "canceling or postponing all non-essential meetings through the month of April," an agency spokesperson told BioCentury. "Where possible the agency will leverage technology to host meetings allowing for remote participation."
FDA has not yet announced whether it plans to postpone any of the five advisory committee meetings on its April calendar, including an April 21 meeting of the Pulmonary-Allergy Drugs Advisory Committee to discuss an sNDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol to reduce mortality in patients with chronic obstructive pulmonary disease (COPD).
Grounding FDA staff, postponing foreign inspections
FDA's COO Jim Sigg told all agency employees Tuesday that “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.”
Sigg also announced that FDA has “postponed all foreign inspections that are not determined to be mission critical for the months of March and April 2020," adding that the agency “will continue to conduct foreign inspections that are determined to be mission critical.”
FDA did not respond to BioCentury's inquiries about the effect of travel and inspection limitations on drug application timelines, but Chad Landmon, chair of the FDA practice at law firm Axinn, Veltrop & Harkrider LLP, told BioCentury, “It will have an impact, both delaying approvals - particularly on the generic pharmaceutical side - and potentially having an impact on the supply of products.”
While generics will be most heavily affected because they rely to a great extent on China and India for supplies and manufacturing, new drug applications could also face delays.
Delays are particularly likely for companies that manufacture drugs overseas and that are in the midst of resolving compliance issues, Landmon said. “Any companies that are dealing with compliance issues that they think they’ve resolved and that are waiting for a final inspection from FDA could see an impact.”
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