Recently, the attorneys at Ropes & Gray wrote an article reviewing the United States Food and Drug Administration’s (FDA) 2020 enforcement priorities, including protecting patients from those who attempted to exploit the COVID-19 pandemic through marketing phony products and treatments. As the alert notes, most of the enforcement actions were focused on the pandemic, but there were also “noteworthy developments in more traditional areas of FDA enforcement.”
COVID-19 Enforcement
The article notes that the FDA created a COVID-19 Fraud Task Force to “share and analyze consumer complaints and reports about” the marketing of unapproved medical products as safe and effective for either the treatment, cure, or prevention of COVID. In addition to the task force, the FDA launched “Operation Quack Hack,” which resulted in thousands of product that made potentially violative claims about COVID-19 being identified – including teas, botanical oils, and chlorine dioxide products. Throughout the year, FDA issued almost 150 warning letters for unapproved, adulterated, or misbranded products intended for COVID use, with the majority of those letters focused on products marketed with drug claims.
The Department of Justice (DOJ) and Department of Homeland Security (DHS) also stepped in to help the FDA in varying enforcement actions.
Moving Forward
Going forward, it’s likely that the government will continue to target companies and individuals who are making unsupported and/or misleading claims about unapproved or unauthorized medical products related to COVID-19. Ropes & Gray also suggested that future enforcement is likely to target noncompliance with emergency use authorizations or enforcement discretion policies by new and veteran industry entities alike. It’s also possible that entities that received “significant federal funding may also find themselves under the microscope, especially if problems are identified in connection with the products they have been funded to produce.”
Opioids
Not surprisingly, opioids continued to be a focus for the FDA in its enforcement activity. In 2020, the FDA launched a 120-day pilot program with the Department of Commerce’s National Telecommunications and Information Administration to target unapproved opioids that were illegally being sold online. Under the program, the FDA flagged website operators that received, but not timely and adequately responded to, FDA warning letters. By flagging those operators, it allowed the internet registries to decide whether to suspend or block certain domain names.
The FDA also sent warning letters to 17 website operators in September 2020 for distributing unapproved and misbranded opioids.
Medical Products and Devices
Ropes & Gray believes that misleading promotional practices are likely to continue to be a target for both the FDA and the DOJ into 2021 – especially in connection with fraud related to COVID-19.
In 2020, the FDA Office of Prescription Drug Promotion (OPDP) sent four warning letters related to the inappropriate promotion of approved drugs and two untitled letters, which took issue with promotional materials distributed by companies that OPDP found to be either false or misleading due to inadequate risk presentation.
The FDA also continued its scrutiny of homeopathic drugs, with 21 homeopathic drug-related warning letters issued in 2020 – up from 14 similar letters issued in 2019.
Regenerative Medicine
In 2020, Ropes & Gray noted that the FDA continued to focus policymaking efforts on cell and gene therapies as well as human cells, tissues, and cellular and tissue-based products (HCT/Ps), though neither the agency nor the DOJ took any significant enforcement actions in that realm.
Last summer, the FDA issued a consumer alert on unapproved regenerative medicine products and revised its regenerative medicine policy framework. The agency also extended its enforcement discretion policy with respect to Investigational New Drug (“IND”) and premarket approval requirements for certain HCT/Ps.
This Year
As indicated above, Ropes & Gray expects that the FDA and the DOJ will both continue to focus violations of law involving COVID-19 fraud in the coming year. They also noted an expectation of a renewed focus on medical product manufacturing and quality issues when FDA inspections return to their pre-pandemic volume.