Commentary Discusses Importance of Communicating Drug Information to Clinicians
SUMMARY: The most direct way that the Food and Drug Administration (FDA) communicates prescribing information to clinicians is through the drug label. However, critical information that the FDA has at the time of drug approval may not appear on the drug label or in relevant journal articles.
Data on harms may be lost, as in the case of missing mortality data for a higher dose of the drug Zometa.
Data on efficacy may be lost, as in the case of Lunesta, in which patients in drug trials still met the criteria for insomnia while taking the drug, even though they reported falling asleep faster and sleeping longer than those on placebo.
FDA approval means only that the agency deemed the benefits of a drug to outweigh its harms; clinicians cannot distinguish between drugs that reviewers endorsed enthusiastically and those that they viewed with great skepticism, for which approval may have been a “close call.”v
The FDA has not issued new guidance about its drug-review documents, which are often lengthy and inconsistently organized. Authors suggest that a standardized executive summary including data tables of the main results of phase 3 trials, highlights of reviewers’ uncertainties, and notes on whether approval was conditional on a post-approval study would be an improvement.
When companies apply for drug approval, FDA reviewers may spend as long as a year evaluating the evidence, and publicly available review documents record the reasoning behind approval decisions. However, in many cases, information is lost between FDA approval and the approved drug label, which is written by the drug company. This commentary reviews several instances of information not included on drug labels and suggests the importance of better communicating this information to clinicians.
Both authors are part of the VA Outcomes Group at the White River Junction VAMC, Vermont.
Schwartz L, Woloshin S. Commentary: Lost in Transmission – FDA Drug Information that Never Reaches Clinicians. New England Journal of Medicine 2009 Oct 29;361(18):1717-20.