Disease-awareness advertisements may be slipping through the regulatory cracks at the expense of patients and to the advantage of the pharmaceutical industry. Despite FDA’s focus on drug labeling to help protect patients from drugs that may not be safe and effective for them by controlling what drug companies can say in advertisements, disease awareness ads that don’t mention a drug name are not as tightly regulated. Recent FDA actions on testosterone products revealed the power of these advertisements and the consequences of the government’s hands off regulatory approach. I set out to explore what, if any, government agency has the authority to regulate disease-awareness ads and how the regulation, or lack thereof could have led to the unintended consequence of the prescribing of drugs for patients for whom the FDA did not intend their use. I found that while FDA pushed off much of the responsibility for disease-awareness ad regulation at an advisory committee meeting, agency documents indicate it has more regulatory authority than it let on. I also found that while FTC does have some jurisdiction over the topic, it was unlikely to investigate such communication unless prompted by direct complaints; yet FDA refused to tell me whether it had passed any complaints or its concerns over to FTC.
