Pandemic Impacts Seen in FDA’s Offices of Pharmaceutical Quality, Generic Drugs

The latest annual reports from the FDA’s Office of Pharmaceutical Quality (OPQ) and its Office of Generic Drugs (OGD) both highlight the impact of the COVID-19 pandemic on their activities in the past year.

OGD approved “more than 660 supplements and 50 original applications … for drug products used to treat patients with COVID-19” while OPQ staff contributed to 11 FDA guidance documents dealing with COVID–19.

Due to pandemic travel restrictions, OPQ had to postpone “non-mission-critical facility inspections,” but found ways around that, “avoiding the need to conduct 153 on-site facility inspections prior to approving applications.”

OGD created a system for “identifying generic drugs that are critical to the treatment of patients with COVID-19” and accelerated reviews of those products. It also supported manufacturers of approved generics who needed to make changes to manufacturing processes or facilities to address disruptions caused by the pandemic, including antibiotics, sedatives used in ventilated patients, anticoagulants and pulmonary medications.

For the current year, OPQ said it plans to focus on “promoting manufacturing innovation and incentivizing manufacturers to strive for mature quality management at their facilities,” including by developing a rating system for quality management maturity at manufacturing plants.

Read the Office of Generic Drugs annual report here: www.fdanews.com/02-11-21-OGD2020AnnualReport.pdf.

Read the Office of Pharmaceutical Quality annual report here: www.fdanews.com/02-11-21-OPQAnnualReport2020.pdf. — Martin Berman-Gorvine