Over-the-counter (OTC) drugs – from raw material supply through product manufacturing and distribution – remained a central concern at the FDA Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) during 2019.
The shift of attention onto CGMP compliance in the OTC arena, which began with the agency’s FY 2017 (ending September 30) and continued through FY 2019, reflected the impact of the FDA Safety and Innovation Act (FDASIA), passed by Congress in 2012.
FDASIA gave FDA the authority to move from a strict two-year inspection mandate for US drug facilities – a mandate which consumed a significant amount of resources – to determining its inspection coverage on a risk-based schedule globally.
In the wake of FDASIA, FDA did a more careful assessment of its previously uninspected facility inventory. The assessment found that there were about 1,000 facilities overseas in this category – heavily weighted on the OTC side. FDA made a commitment to the Government Accounting Office (GAO) to complete these inspections between FY 2017 and FY 2019.
However, at the end of FY 2018, OC was reporting that these foreign inspections were nearly completed – a full year ahead of the commitment – allowing FDA to shift attention onto the previously uninspected domestic part of its inventory during FY 2019 [See IPQ October 22, 2018 for a review of the CDER compliance activity and developments during FY 2018).
Altogether about 25% of these foreign drug manufacturing inspections were classified as “official action indicated” (OIA) – meaning that CDER’s compliance office would now be involved in working out the appropriate follow-up enforcement action.
About 80% of the previously uninspected inventory found non-compliant and receiving a warning letter were OTC firms, with about 15% API and 5% other finished dosage form facilities.
The overall result of the initiative was a significant rise in warning letters and import alerts during the three years, as well as in the relative percentage of OTC firms in the drug CGMP warning letter totals.