CDER’s Office of Compliance Reports on its Activities in 2020

The Center for Drug Evaluation and Research (CDER) highlights efforts to deal with drug shortages, sham COVID-19 products and poorly compounded drugs, as well as its enforcement successes amidst the pandemic, in its latest annual report from its Office of Compliance, released yesterday.

After the March 2020 postponement of most foreign and domestic routine inspections, CDER turned to evaluating facility compliance mainly through records or information requests in lieu of or in advance of inspections. Using those new methods, it placed 12 manufacturing facilities that were prioritized for a surveillance inspection on import alerts, according to the annual report.

The FDA also leveraged its mutual recognition agreement with the EU to obtain information on drug inspections, using the information to place one manufacturing facility on import alert during the year.

Throughout 2020 and the coronavirus crisis, the agency took enforcement actions against individuals and companies selling products with unproven claims to prevent or treat COVID-19, issuing 99 warning letters. In addition, it sent 11 warning letters to internet pharmacies selling unapproved drugs they claimed could treat the virus. It also worked with the Department of Justice to obtain injunctive relief against two companies that failed to take appropriate actions.

The agency also issued 45 enforcement discretion decisions to boost supplies of key drugs amidst the pandemic, including for remdesivir, heparin, albuterol, etomidate, midazolam, propofol and many other drugs. Additionally, it published guidance that temporarily allowed registered outsourcing facilities to compound 13 drugs essential for hospitals.

The Office of Compliance also took significant actions to improve the quality of compounded drugs in 2020. For example, it released a final guidance document detailing the insanitary conditions it has observed during inspections of compounding facilities and the corrective actions facilities should take to address them. It also issued a revised draft guidance on applying current good manufacturing practices (CGMPs) requirements based on the size and scope of a facility’s operations.

The report also notes the finalization of a memorandum of understanding (MOU) between the FDA and states designed to give states a greater ability to regulate compounding pharmacies and the quality of their products. States have until Oct. 27, 2021, to sign the MOU before they face a five percent limit on compounded drugs distributed out of state by physicians, pharmacists and pharmacies in states that don’t sign the memorandum.

Read the Office of Compliance annual report here: www.fdanews.com/03-23-21-OCAnnualReport2020.pdf. — James Miessler