Friends of Cancer Research Congressional Briefing
Safeguarding the Public Health: Enhancing Information About Prescription Drugs

Patients and their caregivers need access to high quality information about the prescription drugs they use. While many sources of information exist, none can deliver as strong assurances of reliability and scientific rigor as FDA-approved product labels. Labels are the most carefully-vetted sources of prescribing information available today and play a critical role in safeguarding the public health.

“My main fear is that outdated recommendations on labels wind up harming patients.” – Janet Woodcock, FDA

A new study by Friends of Cancer Research (Friends) shows that most cancer drug labels are considerably out of date, despite the critical role they can play in promoting informed treatment decisions. The study, “Outdated Prescription Drug Labeling: How FDA-Approved Prescribing Information Lags Behind Real-World Clinical Practice,” which was published in the peer-reviewed journal Therapeutic Innovation and Regulatory Science, presented new data showing 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 over 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. The NCCN Compendium is a resource created by practicing oncologists to guide treatment decisions with cancer drugs. The report identified more than four times as many uses on the Compendium than on drug labels (99 uses on labels vs. 451 uses in the Compendium), a staggering difference between two sources that 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 “off label,” meaning that these uses were not approved by the FDA.

“Our research shows that FDA-approved labels are woefully out of date.” – Jeff Allen, Friends of Cancer Research

To highlight the issue and release this new research, Friends hosted a briefing on Capitol Hill on March 20, 2018. The ninety-minute event was comprised of a panel of experts, including Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, the opportunity to discuss the importance of FDA-approved prescription drug labels and react to the findings of the Friends study.

The primary concern over outdated prescription drug labels is that physicians prescribing drugs outside of their area of expertise who look to labels to inform their decisions may come away with incomplete or incorrect information. Asked by the briefing’s moderator, Kate Rawson of Prevision Policy, about how outdated labels may harm the public health, Dr. Woodcock noted that a lot of medicine is practiced outside a physician’s specialty, and patient harm can result from prescribers using outdated labels to learn about drugs they don’t typically use. She gave several examples of drugs with outdated labels that may be used in this way: lithium, methotrexate, as well as many antibiotics currently on the market.

“Labels do not age like fine wine—new data constantly comes out that is not readily incorporated.” – Angus Worthing, American College of Rheumatology

Other members of the panel weighed in on how outdated labels are currently used in clinical practice. Dr. Angus Worthing, a rheumatologist and member of the American College of Rheumatology, noted that labels are most useful at the time of approval, but quickly become outdated as new information emerges. He also noted that reimbursement for many uses of rheumatology drugs is contingent on FDA approval, and thus only labeled uses are covered. Dr. Angela Green, an oncologist at Memorial Sloan Kettering Cancer Center, noted that labels form the basis for many other sources of information that physicians use to make prescribing decisions, and outdated information can lead to poorer treatment decisions.

“Under the current regulatory and legal framework, there are significant disincentives to keeping labels up to date.” – Josephine Torrente, Hyman, Phelps, & McNamara PC

The legal and regulatory causes of outdated labeling are complex and varied, according to Josephine Torrente, a partner at the law firm Hyman, Phelps & McNamara, and another participant at the briefing. She noted that the crux of the problem may very well be in the generics space, where generic drug labels are often “frozen in time” due to quirks in the current regulatory system. She also noted the significant lack of incentives for drug manufacturers to update labeling on a regular basis.

Following the briefing and the release of the study on outdated labeling, Friends will gather consensus around a set of proposals to ensure that important information is added to labels where it is currently absent. Furthermore, due to the significant disincentives to updating labels under the current framework, Friends will propose ways for FDA to play a more active role in facilitating timely inclusion of new information on labels, particularly for generic drugs and older, off-patent products.