FDA to study how drug promotion affects doctors' decisions
- The Food and Drug Administration is planning to survey 2,000 healthcare professionals to better understand how prescription drug promotion affects the decisions they make.
- Promotional activities include meetings with pharmaceutical sales representatives, presentations given at industry-sponsored events, and journal or direct mail advertisements. In 2012, drugmakers spent north of $24 billion marketing their products to physicians, according to data cited by the FDA.
- "Although HCPs are learned intermediaries, like most people, they may rely on heuristics in making decisions and may have cognitive biases in the type of information they attend to at any given time. They may be persuaded by strong statements and may not have the time to ascertain accuracy of such information," the FDA wrote in a notice posted on the Federal Register on March 15.
Pharmaceutical companies know the arduous process of bringing a drug from bench to bedside doesn't mean much if doctors don't end up prescribing it. Ergo, marketing strategies are a vital tool to ensure a return on investment.
It's therefore no surprise that these companies invest tremendously to get their products in front of HCPs. That $24 billion spent on promotional activities in 2012 was around eight times what drugmakers spent on direct-to-consumer advertising.
Such investments are problematic for regulators, who worry they might be swaying doctors prescribing habits — or at the very least providing them with incomplete profile of a drug.
"Several studies indicate that data presented in promotional materials may not be fully comprehended and may even potentially be misleading due to a variety of causes, such as insufficient information, unsupported claims, or a failure to disclose limitations of the information presented," the FDA wrote in its notice.
To be fair, there's still a great deal not known about the dynamic between drug promotion and HCPs' decision-making. A World Health Organization report from 2005 noted that studies really hadn't identified any significant generalizations for doctors' attitudes toward promotional activities. What's more, many of studies relied too much on quantitative data, according to WHO.
"There is little qualitative research on people’s attitudes to promotion, and this is a major gap," the organization said. "In order to understand people’s perspectives and values more clearly, in‐depth interviews are needed. People should be express themselves in their own way about what they think about promotion and how it affects them."
Along a similar line, the FDA plans on surveying 700 primary care physicians, 600 specialists, 350 nurse practitioners and 350 physician assistants. The general questions touched on in the surveys include:
- What methods and/or channels are used to disseminate prescription drug promotional information to health care professionals/prescribers?
- How knowledgeable and interested are HCPs in clinical trial data and its presence in prescription drug promotion?
- How familiar are HCPs with the FDA approval of prescription drugs and how does this translate into practice?
"The proposed survey will provide further insights about how professionally targeted prescription drug promotion might influence health care professionals' decision-making processes and practices and how information may be communicated more effectively," the agency wrote.
- Food and Drug Administration Proposed survey
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