The US Food and Drug Administration (“FDA”) recently published a notice in the Federal Register seeking to find out more about how drug manufacturers promote to consumers drugs that have received approval under the accelerated approval pathway. The FDA is concerned that such advertisements can be misleading.
The accelerated approval pathway allows for early approval of drugs that treat serious conditions, and that fill an unmet medical need, based on data generated from surrogate endpoints, such as laboratory measurements, radiographic images or physical signs. Surrogate endpoints are not themselves measures of clinical benefit, but are thought to predict clinical benefit.
The FDA, through its Office of Prescription Drug Promotion (“OPDP”), intends to conduct a study, through the use of internet panels, to determine if direct to consumer (“DTC”) marketing of accelerated approval drug disclosures are confusing to the public. Drug manufacturers are required to include prescribing information (“PI”) for accelerated approval drugs which provides to healthcare providers the limitations of usefulness of the drug, as well as any uncertainty about clinical benefits. The PI is typically complex, containing sophisticated and technical language. Often, the drug manufacturers simply repeat this highly-technical PI language in their DTC marketing campaigns.
The OPDP study will focus on oncology products as they are often granted accelerated approval, and because they are often the focus of DTC campaigns. The study will consider whether the participants notice and understand disclosures for a fictional oncology drug, and whether they understand the fictional drug’s risks and benefits. The study will also determine if varying the presence and prominence of the disclosure will affect the participants’ perceptions of the drug, as well as the effects of using consumer-friendly language as compared to technical PI language.
This study follows a prior study conducted by OPDP, the results of which were published last fall. In the prior study, the OPDP examined 26 DTC advertising websites for accelerated approval drugs to determine whether and how accelerated approval is communicated to consumers. The study found that, while 73% of the websites contained accelerated approval disclosures, most conveyed the information in “medical terms.” The authors concluded that DTC websites for accelerated approval drugs “do not consistently communicate the accelerated approval information for the product to consumers in a prominent, comprehensive or readable manner.”
The Trump administration has repeatedly called for increasing the speed of the drug approval process, so issues like DTC marketing for accelerated approval pathway drugs are likely to be remain a focus of the FDA in the coming years.