As medical care rapidly evolves, there’s really no debate over the potential for drug labels to become outdated, particularly in the high stakes world of cancer treatment. The question is how best to ameliorate the problem, while still protecting the process from financial and other conflicts.
Off-label prescribing of cancer drugs is common, occurring 30% of the time, according to a frequently cited 2013 study in the Journal of Clinical Oncology, which looked at 10 chemotherapy drugs. Some drugs, such as gemcitabine and rituximab, were used off-label two-thirds of the time, while pemetrexed and trastuzumab were prescribed off-label less than 10% of the time.1
While cancer physicians can reference various compendia, most notably from the National Comprehensive Cancer Network (NCCN), that’s a lot of drug information for busy doctors treating patients with numerous malignancies to stay on top of, said Jeff Allen, PhD, chief executive officer at Friends of Cancer Research. “What we’ve found is that the discrepancies between the label and the recommended uses may ultimately cause confusion,” Dr Allen told Cancer Therapy Advisor.
The nonprofit organization last year backed S. 3519 to provide Food and Drug Administration (FDA)officials the authority to update generic drug labels with newer treatment insights.2 Dr Allen said that the Washington, DC-based organization is hopeful that the bipartisan legislation will be reintroduced this session with a new cosponsor, following the retirement of Sen. Orrin Hatch (R-UT).
But S. 3519 is not the only sign that federal leaders are looking at ways to better align what’s on the label with the most recent science. In senate committee testimony in the Spring of 2018, FDA Commissioner Scott Gottlieb, MD, pointed out that when the brand-drug sponsor voluntarily withdraws its marketing application, there’s no sponsor responsible for making such updates to the generic version. “The result is that these drug labels get frozen in time,” Dr Gottlieb said.3
While more frequent updating of labels is a laudable goal, the challenge will be how to structure the process so that drug manufacturers, patient advocacy groups, or others with a vested interest don’t wield a disproportionate influence, said Tewodros Eguale, MD, PhD, an associate professor in the pharmaceutical economics and policy department at Massachusetts College of Pharmacy and Health Sciences,Boston. Dr Eguale coauthored a study in 2016 looking at off-label prescribing,which found that 80.9% of off-label prescribing wasn’t backed up by strong scientific evidence.4
“It’s always the dilemma,”Dr Eguale said. “Are you going to go with the science or are you going to go with the testimony by the clinician or the patient?”