Friends of Cancer Research (Friends) recognized Senators Orrin Hatch (R–UT) and Michael Bennet (D–CO) for responding to a recently identified public health issue and proposing a solution to an issue impacting patients and their physicians. Senators Hatch and Bennet jointly introduced the Making Objective Drug Evidence Revisions for New Labeling Act, or MODERN Labeling Act.
The legislation addresses the prevalence of outdated labels for drugs by giving the U.S. Food and Drug Administration (FDA) the authority to require updating labels to reflect new information relevant to the drug and its use when the approved label has been withdrawn. This Act also determines a process by which the FDA can identify labels to be updated and notice label holders as well as the label holders can submit modifications to the notice.
“We are truly grateful for the work Sen. Hatch and Sen. Bennet, along with their staff, did to translate a study that was conducted by Friends into a legislative solution in such a short amount of time,” said Jeff Allen, President and Chief Executive Officer of Friends. “We commend their bipartisan action to improve public health and urge Congress to pass the MODERN Labeling Act into law.”
Outdated Prescription Drug Labeling
Earlier this year, Friends hosted a congressional briefing on the topic of outdated labels. At the briefing, new data were presented showing a number of out-of-date FDA-approved prescription drug labels. The study was published in the peer-reviewed journal Therapeutic Innovation & Regulatory Science.1 The article showed that most FDA-approved cancer drug labels are missing critical information on drug effectiveness.
The authors of the report analyzed information on 43 drugs approved during a 12-year period, from 1999 to 2011, comparing the number of FDA-approved indications visible on labeling to the number of uses recommended in the National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium® (Compendium). The report found there were more than four times as many uses on the Compendium than on drug labels, a huge discrepancy considering both purport to offer prescribers guidance on the appropriate uses of cancer drugs. The report also found that 56% of the uses included in the Compendium were not approved by the FDA.
Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research at the FDA, expressed concern over outdated prescription drug labels and their potential effect on physicians prescribing drugs outside of their area of expertise, who may look to labels to inform their decisions and may come away with incomplete or incorrect information. “My main fear is that outdated recommendations on labels wind up harming patients,” noted Dr. Woodcock. ■
1. Shea MB, Stewart M, Van Dyke H, et al: Outdated prescription drug labeling: How FDA-approved prescribing information lags behind real-world clinical practice. Ther Innov Regul Sci. January 1, 2018 (early release online).