FDA Office of Compliance Issues Annual Report

Recently, the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Compliance (OCC) released its annual report, outlining the enforcement activities the agency took last year, such as those involving decisions to increase supplies of medicines for COVID-19 and the use of inspection alternatives. As Donald D. Ashley, JD, notes in the Director’s Message of the report, part of the agency’s responsibilities last year included shielding patients and consumers from unsafe hand sanitizers and products fraudulently claiming to prevent, treat, or cure COVID-19.

Ashley further noted what he might consider the “most significant [achievement] in 2021,” taking action to remedy data integrity violations at two contract research organizations in India — Panexcell Clinical Lab Pvt. Ltd., and Synchron Research Services Pvt. Ltd. Both contract research organizations had falsified data submitted to the FDA in support of more than 100 new and generic drug applications; CDER has since requested new bioavailability and bioequivalence studies from sponsors.

In 2021, the agency issued 149 warning letters across compliance programs, obtained two injunctions, oversaw good clinical practice inspections and issued clinical inspection summaries for more than 122 new drug and biologic applications. The agency also2 assisted in preventing or mitigating shortages for 59 different medications.

Reorganization

In 2021, OCC implemented several organizational changes, including the creation of the Office of Compounding Quality and Compliance (OCQC), which brings together the Office of Unapproved Drugs and Labeling Compliance and the Office of Manufacturing Quality.

In addition to the creation of the OCQC, the Office of Unapproved Drugs and Labeling Compliance (OUDLC) now combines functions of the Drug Registration and Listing Staff with similar functions of OUDLC, specifically the labeling component. This realignment establishes the Division of Labeling, Registration and Unapproved Drugs, which includes the Drug Registration and Listing Branch and the Over-the-Counter Drugs Branch. Additionally, the Division of Unapproved New Drugs is renamed the Division of Unapproved Drugs and Labeling and maintains the Fraud Drugs Branch and the Prescription Drugs Branch.

The Office of Drug Security Integrity and Response also changed its operations, dividing the Import Export Compliance Branch into two branches — Imports Compliance Branch and Exports Compliance Branch — within the Division of Global Drug Distribution and Policy. Additionally, within the Division of Supply Chain Integrity, the Supply Chain Strategy and Policy Branch is renamed to the Supply Chain Security Branch.

COVID-19 Response and Alternative Tools

The agency kept the COVID-19 pandemic front and center throughout 2021. Historically, a large percentage of the compliance and enforcement actions have been based upon inspection results. However, given the impact the pandemic had on feasibility of inspections, the agency had to use alternative tools to support compliance and enforcement actions.

One of the alternative tools was collecting samples of imported drug products at the borders. FDA analyses of the collected samples identified products that contained contaminants or did not meet quality standards for potency. This is how the agency found that 84 percent of hand sanitizers imported from Mexico between April and December 2020 were not in compliance with FDA regulations. Therefore, in January 2021, the agency put in place an import alert for all hand sanitizers from Mexico, marking the first time the FDA has issued a countrywide import alert for any category of drug.

With respect to COVID and enforcement actions, the agency issued 15 enforcement discretion decisions to increase supplies of albuterol, oxygen, propofol and many other critically needed medications. One request regarding industrial grade oxygen for medical use due to significant shortages and increased demand due to COVID-19, was considered and approved in less than eight hours on the condition that oxygen distributors met several key quality and safety conditions, including testing for impurities prior to distribution and immediately reporting any serious adverse events.

Compounding

The agency issued several Compounding Risk Alerts throughout the year, including one on October 25 to ensure that medical offices and clinics were aware of the risks of compounded drug products prepared under insanitary conditions as well as their obligation to comply with federal and state regulations.

Opioids

As one might expect opioids remained front and center at the agency’s focus – in 2021, the agency expanded its focus to include controlled substances sold illegally online on the same sites that sell opioids.

The agency issued two warning letters in 2021 to companies that were selling fraudulent opioid addiction treatments, bringing the total number of warning letters to more than 50 for websites that illegally sell opioids over the internet since 2017.

The agency also virtually hosted the third Online Opioid Summit on September 9, which brought together internet stakeholders, government entities, academia and other partners. Topics discussed include the evolving landscape of online opioid purchasing, including that younger and more vulnerable populations are exposed to dangerous opioids via social media. The summit also discussed ways to enhance cross-industry and global collaboration, successes and novel solutions implemented since previous summits, and new ways to continue to prevent the illegal sale of opioids through internet platforms and services.

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