Top FDA official: Listing detailed drug risks in pharma TV ads a 'waste of time'
- Bloomberg reports that Richard Pazdur, director of the office of hematology and oncology products at the FDA, has some strong words about detailed lists of side effects in pharmaceutical DTC television advertising.
- "It’s just a waste of time," said Pazdur of the practice, calling it a mere "litany of complaints."
- The FDA has been conducting an extensive study on the effectiveness of side effect lists in advertising, including whether or not patients actually understand those risks.
Could those (sometimes comically) long lists of side effects for a drug become a thing of the past?
It's too early to tell, but it is clear that the FDA and officials like Pazdur want to seriously rethink pharma's approach to risk mitigation in advertising. Pazdur pointed out just one example: "'Don’t use if you have MAE1...' What patient knows what MAE1 is?
"[I] would encourage the agency to look at this whole advertising issue in a much more innovative approach."
It's possible that the FDA, after concluding its DTC study, could recommend that companies only list the most harmful side effects and say of more minor ones that "other harms" are possible with a given drug.