Do you ever look at the labels of the prescription medications you take? Or do you simply rely on your physician to read them to understand the medications’ appropriate uses and side effects? Either way, there’s a good chance that these labels — the detailed instructions for use that accompany every drug approved by the Food and Drug Administration — are out of date and lacking essential new information for appropriate use and safety.
Accurate drug labeling is fundamental to safe and effective prescribing and use. It’s also something most of us take for granted. Yet many labels have been steadily falling out of date, to the point where this has become a serious public health problem.
Congress must fix this problem — and fast. As part of its reauthorization of the Prescription Drug User Fee Act this summer, Congress should broaden the authority of the FDA to actively encourage drug manufacturers to develop a mechanism to more readily incorporate high-quality information into drug labels over time.
How does something so basic and important to the safe and effective use of medicines fall out of date? For starters, it is impossible to know everything about a drug when it is first approved. What a drug is used for, and information about its safe use, evolves based on clinical experience and data from new clinical trials. Information gathered over time can help identify new populations that can benefit from the drug, such as children, or reveal an entirely new use of a drug, like a drug initially approved for colon cancer that’s now used against kidney cancer. New information can also help physicians modify dosing and offer modernized instructions for safe use.
Unfortunately, information contained in the label often lags far behind the evolution of a drug’s use. Drug makers can update product labels to include additional uses when new data supports such modifications. In many cases, though, they don’t do this because there’s little incentive to do so, especially when a drug is no longer being actively marketed or when its patent has expired and it faces generic competition.
The problem is widespread. An investigation by my organization, Friends of Cancer Research, found that leading oncologists recommended additional uses beyond those listed on product labels for 79 percent of cancer drugs approved between 1999 and 2011. This means that a large number of well-accepted uses of cancer drugs that emerge over time are completely absent from drug labels.
Since many of these recommended uses are supported by strong evidence of effectiveness, patients may wind up receiving outmoded care if their physicians rely solely on labeling to guide prescribing decisions. To prevent this from happening, drug labels should be updated to ensure that patients don’t miss opportunities to benefit from new treatments or receive the safest, optimal doses. A process to readily add new information to the label would reinforce the uses of the drug supported by high-quality evidence.
Outdated labels aren’t just a problem for cancer drugs. The American College of Rheumatology has cited numerous examples of drugs that are used widely in arthritis and other joint-related diseases but lack updated labeling. Take the drug methotrexate. Despite being the standard of care for a large number of rheumatologic conditions, the drug label lists only three. When labels are missing critical information like this, particularly regarding diseases other than cancer, insurers often refuse coverage, putting added strain on patients.
Recent policy debates related to drug labels have focused on the communication of unapproved or “off-label” uses of drugs already on the market. This topic has been debated for decades, including by the U.S. Supreme Court. It’s an important and complex issue, and updating labels is not intended to resolve this debate. However, the information in the drug label serves as an unbiased and factual basis from which communication about a drug’s use is derived. Identifying and incorporating safety data and effective uses into outdated labels would allow this information, when supported by high-quality evidence, to be more readily available to patients and care providers.
The absence of up-to-date information about safe and effective use on drug labels raises serious concerns. It also contributes to the erosion of public trust in prescription drugs and the FDA approval process they represent. Some argue that labels don’t need to contain information about new uses of already approved drugs because other sources of drug-related information, such as clinical guidelines or drug compendia, can sufficiently provide assurances of safety and effectiveness in the absence of FDA approval. While these resources are and will continue to be essential, we should not neglect FDA-approved labeling as an indispensable source of information.
In the long run, letting labels fall out of date will do a lot of damage by undermining reliance on the drug approval process, which was put in place to protect patients and safeguard public health.