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Prescription Drug Labels Get User-Friendly Overhaul

January 19, 2006

FDA action is designed to help doctors and consumers, officials say

U.S. health officials announced Wednesday a major overhaul of the package inserts that accompany prescription drugs.

It’s hoped that the changes, designed to be easier to read and understand, will benefit not only doctors and other health-care workers, but consumers as well, officials said at a news conference.

“We see this as a platform whereby we can build much better consumer information,” said Dr. Janet Woodcock, deputy commissioner for operations at the U.S. Food and Drug Administration. “This is just one step in getting better prescribing information to the people who need it.”

The revisions, the first since 1975, will require that package inserts include a “prominently displayed summary of key information including indications, usage, dosage and administration,” said FDA acting commissioner Dr. Andrew von Eschenbach. This summary, or “Highlights” section, will be about half a page in length, he said.

Health-care professionals can also expect to see a table of contents, patient-consulting information to ease communication between doctor and patient, as well as a toll-free number and Internet reporting information for suspected side effects. Drug manufacturers will also be required to provide a list of all substantive changes made to the product during the past year.

Updated prescription information will also be incorporated into DailyMed, an online health information clearinghouse.

The initiative is intended to reduce the number of preventable “adverse events” — now estimated at 300,000 annually — that occur in hospitals in the United States, officials said.

“As the future of medicine moves toward patients taking more complex and multiple medications, it will matter how we present and how we utilize this important information,” said von Eschenbach. “This initiative is a significant step toward facilitating that future.”

The new format should also simplify the legal minutiae that currently clutters most package inserts.

The guidelines will take effect in about 120 days. New drugs will automatically be covered by the new format, von Eschenbach said. Drugs approved within the past five years will ultimately be required to abide by the changes. Drugs older than that will not be subject to the requirements, but manufacturers are being “encouraged” to update their inserts, he said.

“This is going to be a rolling timeline going forward,” von Eschenbach said.

The move should also prove useful as medicine continues its transition into the electronic realm, Woodcock said.

“FDA believes we are moving the prescribing information into the information age,” she added. “These changes will not only enable better access to paper information, but will enable the revolution in electronic prescribing information that we hope will revolutionize the safety and ability to use medication in the best possible way.

The new rules were first proposed five years ago.

According to the Associated Press, the pharmaceutical industry is concerned that less warning information will expose companies to greater liability. Apparently in response, the FDA has reaffirmed that federally approved drug labels preempt state liability laws, which, in turn, has upset some state officials.

Von Eschenbach said new rules involve “no relaxation in any of the standards.”

For patients and health-care providers, the new format is intended only to make things easier, officials said.

“Labels need to be reclaimed for patients and physicians,” said Dr. Scott Gottlieb, deputy commissioner for medical and scientific affairs at the FDA.

The public advocacy group Public Citizen said the insert revisions are a good first step but don’t go far enough to protect consumers.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said the revisions will simplify and prioritize the labeling information that doctors receive. But the vast majority of patients will not get that information unless they specifically request it. Instead, they will receive patient information leaflets that are commercially produced but whose content is not scrutinized by the FDA.

“It is time to end the double standard where doctors and other health professionals are informed by FDA-approved labeling, but patients are treated like second-class citizens, receiving whatever the out-of-control purveyors of patient information leaflets choose to dispense,” Wolfe said. “This is a dangerous situation, made worse by the FDA’s poor record of approving harmful drugs based on limited, and even fraudulent, clinical trials performed by the drug companies.”

More information

View updated prescription drug information at DailyMed.




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