FDA Speeds New Guidance Development to Inform Manufacturing and Research During Pandemic

The imperative to accelerate the development and production of new therapies and vaccines to treat patients infected by the COVID-19 virus has prompted a steady wave of new advisories from FDA on strategies for assessing new therapies and for ensuring quality products. The pandemic has required revisions in how companies maintain safe operating practices and how research sponsors assess and implement changes necessary to fit this new reality.

One result of the coronovirus pandemic is an emphasis at FDA on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future. In recent months, the agency has devised a more streamlined process for guidance development due to pressures to address R&D issues quickly, observed Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), at the June 2020 virtual annual meeting of the Drug Information Association (DIA). In considering likely changes in operations from the pandemic, Marks noted that FDA is moving away from what in the past has been a “challenging and somewhat tortured” process, where it often took two or three years of deliberations to devise a guidance document-with the result that the resulting advisory was “often outdated by the time it is published,” he commented. Now FDA staffers resolve their differences quickly, he said, resulting in a shorter process that often produces fresher and more useful documents.

One timely guidance, for example, outlines how manufacturers should ensure that workers who become infected by COVID-19 do not compromise drug products or quality standards. FDA advises manufacturers to evaluate how the coronovirus increases risk of contamination under existing manufacturing controls and what kind of restrictions should be placed on sick workers.

FDA also updated recommendations for developing drugs to treat bacterial pneumonia, in both community and hospital settings, and for ventilator-associated conditions. These final guidances offer new approaches for study randomization, patient enrollment, primary endpoints, and intravenous drug formulations to treat these conditions.

Also important to manufacturers was a final guidance published in March 2020 in response to concerns about increased drug shortages due to the pandemic. FDA updated policies for manufacturers to notify the agency of any anticipated discontinuance or interruption in product manufacturing. Additional advisories in April 2020 provide more flexibility for pharmaceutical compounders to respond more readily to shortages in needed drugs. And a draft guidance issued in May 2020 contains recommendations for permitted daily exposures to three residual solvents, developed by experts collaborating under the International Council for Harmonisation (ICH). The document solicits comments from manufacturers and other experts as part of the process for updating the ICH Q3C guideline on permitted daily exposures to such substances. 

FDA continues to update an overarching guidance published in March 2020 on how sponsors and researchers can modify clinical trials to adjust effectively to health care realities related to the pandemic. Recent additional guidance address the use of alternative laboratory or imaging centers and implementing video conferencing in ongoing studies. FDA also has advised on how and when sponsors should report serious adverse events related to a trial and on accepted changes to informed consent practices to facilitate the use of e-signatures and remote assessments during the pandemic.