For the first time in more than 25 years, the Food and Drug Administration is revamping the format of prescription-drug labels, a move designed to make it easier for physicians and consumers to get clear information about medications.
Drug labels—sometimes called the package inserts—are notoriously complicated documents, printed in tiny script that can stretch on for dozens of pages. Written primarily for doctors, they contain FDA-approved information on dosage and side effects. But patients and doctors alike have complained that the inserts are confusing, and there is evidence that physicians don’t always follow the labels’ recommendations.
The new label rule, which has been in the works for several years, reorganizes the inserts into a more easy-to-follow, standardized format. The plan also includes a government database that will ultimately allow people to search for the information online at dailymed.nlm.nih.gov1.
The changes come as the $250 billion pharmaceutical industry is facing a number of challenges regarding the dissemination of information about drugs, from side effects to clinical-trial data. The industry has closely monitored the development of the new labeling rule. Labels often play a key role in lawsuits brought by people claiming to be injured by a medication. Product-liability lawsuits, such as the high-profile cases brought against Merck & Co. over its withdrawn painkiller Vioxx, have become a huge problem for drug makers.
The drug industry had warned that the new labeling might pose risks to manufacturers facing litigation from plaintiffs claiming they weren’t warned about side effects of medicines, because not all risks would be equally emphasized in the new format. The FDA said that in response to the companies’ complaint, the rule includes a statement that the content of labels should pre-empt state liability laws. (See related article2.)
The biggest change to the labels will be a new summary at the beginning called “Highlights.” Like the nutrition box that appears on food packages, the new highlights section is designed to telegraph the most important information at a glance, using a standardized format. It will summarize the major uses and side effects of the drug, as well as dosing.
The new label format will add some navigational tools, such as a table of contents. It will have the date when the drug won FDA approval, an important piece of information for doctors who are often more comfortable with medicines that have been on the market for several years. The change takes effect in 120 days for all new drugs and new approved uses, and phases in over seven years for medicines approved in the past five years. The changes will be voluntary for older drugs.
The new label layout will also affect advertising, because the string of safety warnings that drug makers must include in print and broadcast ads is based on what’s in the medicine’s label. Drug makers will now be allowed to use the sometimes-shorter list of risks from the highlights section as a basis for their ads.
Physicians say the label changes are important, because the inserts are meant to be the main source for doctors to get information about how to use a drug, as well as potential safety problems. But the old format was often difficult to read and—perhaps because safety information was too easily missed—warnings haven’t always had an effect. A number of drugs, including the diabetes treatment Rezulin, have had to be pulled from the market after physicians didn’t follow label recommendations. One study, published last year and based on patient prescription databases, found that even when drug labels had very strong “black box” warnings and recommended tests for patients starting the medicine, those tests were done only about half the time.
The old layout is “terrible,” says Rebecca Jaffe, a family physician in Wilmington, Del. “The science behind it comes first, and the clinical comes at the very end, but most of us are looking for the clinical information.”
FDA officials said that one goal with the new layout was to ensure that doctors wouldn’t overlook the most important safety information, which now can be buried deep in the document. The new format will “alleviate much of the clutter” on labels and make them “more concise and coherent,” said Andrew von Eschenbach, acting FDA commissioner.
Whether individual consumers get copies of drug labels often depends on if the drug they get comes in its original packaging. If so, it will include the insert. But if the pharmacist has put the pills into a new bottle, as is typical, a consumer won’t always see the official label. Some pharmacies staple summaries based on the labels to customers’ bags.
Patients who don’t get drug labels from their pharmacist will eventually be able to look up the documents in a new DailyMed online library being developed by the government. It is available now but doesn’t yet include all drugs. The labels also can be found at drug makers’ own Web sites. The FDA’s current Web site also features drug labels, though it may turn up an older version of the label.
Doctors say that the new format should make it easier for patients to glean some important facts. One key thing is the medicine’s major potential risks, to be featured in the highlights section. Patients should check these “so they know what they should be looking for while they’re on that medication,” says Ruth Murphey Parker, a professor at Emory University whose research focuses on health communications.
Drug labels also detail another serious safety issue: potentially dangerous side effects that can occur if a drug is taken at the same time as a different medicine. These so-called interactions are also noted in the new highlights section of the label. Less-important and less-frequent risks are also listed farther down in the label, but doctors say that patients shouldn’t overreact to them.
Just as important to patients is information about a medicine’s FDA-approved uses, which are listed in highlights under “Indications and Usage.” Doctors can prescribe drugs “off-label,” or for uses that the agency hasn’t approved. Patients who don’t see their condition under the approved uses section may want to quiz a doctor about such prescriptions. “The evidence is often rather thin” for off-label uses, says Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health at Tufts University.
Labels also lay out the evidence for a drug’s efficacy, typically in the “Clinical Studies” section. Consumers may want to examine the data that got the drug approved, which will help the patient have realistic expectations for “the magnitude of the benefit,” says Steven Woloshin, a researcher at a Department of Veterans Affairs medical center.