Inconsistent regulatory enforcement is a vulnerability in which government regulations are not enforced broadly or evenly, and/or they lack follow-up. These discrepancies allow campaign operators to promote and spread otherwise illicit content regarding scam medical procedures, fraudulent health care opportunities, harmful and unproven therapies, and the like. These inconsistencies could include agencies pursuing certain companies but not others for similar conduct or censuring a company for a violation but never verifying whether that company has remediated as required. The failure of government agencies to consistently enforce regulatory requirements regarding the promotion, sale, or use of specific medical or health-related treatments can result in the spread of misleading or false claims, unauthorized advertising, or other non-government-sanctioned activities.
Political administrations can also be a factor in the prioritization of regulatory enforcement, despite the regulations themselves staying consistent. For example, under former U.S. President Donald Trump, the Food and Drugs Administration, a federal regulatory body, sent 45% fewer “Official Action Indicated” reports (cases in which regulatory and/or administrative actions are recommended) than during an equivalent period under former President Barack Obama, 33% fewer warning letters (where the FDA identifies the violation and makes clear that the company must correct the problem),1 and 26% fewer injunctions (which are a “civil judicial process initiated to stop or prevent violation of the law”).2 The FDA sent fewer letters in Trump’s second year than in his first, indicating a policy of inconsistent enforcement of healthcare regulations even within an administration.3
More broadly, inconsistent regulatory enforcement leads to a risk assessment by campaign operators: If profiteers expect little to no consequences for their actions or believe penalties will not necessarily harm or impede their operations, it disincentivizes adherence to government regulations. This creates a social, economic and/or political vulnerability for campaign operators to exploit.
Inconsistent regulatory enforcement is a Casebook value under the "Vulnerabilities" variable in the code book.
- 1 “About Warning and Close-Out Letters,” Food and Drug Administration, April 29, 2019, archived on Perma.cc, perma.cc/2SAA-NSYS.
- 2“Injunctions,” Food and Drug Administration, March 29, 2019, archived on Perma.cc, perma.cc/F869-BPQW; Charles Piller, “Exclusive: FDA enforcement actions plummet under Trump,” Science, July 2, 2019, archived on Perma.cc, perma.cc/7Y9N-Q5KQ.
- 3 Piller, “Exclusive: FDA enforcement actions plummet under Trump.”