Federal regulators are planning to launch a new study to determine whether consumers and doctors are able to successfully detect deceptive drug websites.
The investigation was announced last month by the FDA, in a posting in the Federal Register (PDF), indicating that the agency’s Office of Prescription Drug Promotion (OPDP) will conduct the study.
The project will actually involve two different studies conducted concurrently. Both will involve consumers and health care providers (HCPs) reviewing mock drug websites. One of the studies will focus on consumers suffering from chronic pain, and the health care professionals who serve in either primary care, internal medicine or direct patient care roles at least 50% of the time.
The other study will focus on patients who suffer from obesity, and the same types of health care providers as in the first study. Obesity will be self-reported by the consumers and defined as having a body mass index of 30 or greater.
“The ability of consumers and HCPs to identify deceptive prescription drug promotion has important public health implications,” the notice states. “If unable to identify deceptive promotion, consumers may ask their HCPs to prescribe specific drugs that they would not otherwise request. Likewise, HCPs who are unable to identify deceptive promotion may prescribe specific drugs that they would not otherwise prescribe.”
At about the same time, the FDA issued new guidance (PDF) for the pharmaceutical industry, giving direction on the requirements for product name placement, and the size, prominence and frequency of promotional labeling and advertisements. The guidance consists of non-binding recommendations for how drug companies should interpret FDA regulations on drug advertisements.
FDA Weighing Shorter Side Effects Lists
The studies come as the FDA weighs changes to drug labeling and advertising rules proposed in 2015, which would allow drug manufacturers to get rid of lengthy lists of all drug side effects in commercials and print ads. Instead, they would only be required to publish the most important potential side effects, while keeping the complete risk information on the drug label.
The FDA proposed this guidance as a result of several findings that indicate consumers are often unable to retain lengthy lists of side effects and typically miss the more serious and severe potential adverse health consequences. Other claims have included consumers often ignore the lengthy side effect list during commercials, or are deterred from wanting to use the medications.
According to the proposed FDA guidance revising direct-to-consumer ads, the inclusion of minor risks “detract from, and make it difficult for, consumers to comprehend and retain information about the more important risks.”
If the guidance is finalized, the FDA says it will not object if, in the future, drug manufacturers fail to include every specific side effect and contraindication in promotional print advertisements. However, these changes will not affect the requirements for the actual drug labels themselves.