Package inserts that accompany every prescription drug are getting a major makeover that will provide doctors and patients with the clear and concise information they need while cutting down on the small-print warnings that only lawyers seem to understand.
Confusing medical information is behind many of the estimated 300,000 preventable cases of death or injury that occur each year in the nation's hospitals, the Food and Drug Administration said Wednesday in publishing new rules on prescription drug labeling.
"We are making the prescribing information much more targeted and useful for physicians," said Dr. Janet Woodcock, the FDA's deputy commissioner for operations. "The prescribing information over the years, as we learned more and more about medicines, has become very congested and complex. We've heard from physicians it's hard for them to find the information they need."
Patients should benefit as well.
"Americans are overwhelmed with the complexity of health information," Surgeon General Dr. Richard Carmona said in a statement. "We have hit a point of information overload and the public health message is being diluted. This is of great concern when it comes to making sure a patient knows how to use prescription drugs safely and effectively."
Publication of the new guidelines comes more than five years after the FDA proposed retooling the look of the labels for the first time since 1975. Since then, minor changes here and there, driven in part by liability concerns and the urge to divulge everything there is to know about a drug, have conspired to make the labels anything but user friendly to doctors, much less patients, FDA officials said.
The new rules banish many of the legal warnings that have choked the multipage inserts and move further to the back the diagrams of each drug's chemical structure that long have introduced the small and densely written pamphlets.
In their place will be more up-to-date and easy-to-read information about the drug, including a box of "highlights" that spell out the most important information about a drug's risks and benefits, the FDA said. The labeling information also will include for the first time novelties like a table of contents and a consistent method of arranging information.
The guidelines will apply to all new drugs 120 days after Wednesday's publication in the Federal Register. Use of the new labels will be phased in over the next seven years for those drugs already on the market, as well as those now under FDA review, Woodcock said.
Other features that prescription drug labels will begin bearing include:
- The date the drug received initial U.S. approval.
- Recent major changes to information about the drug.
- A toll-free phone number for patients or doctors to report suspected side effects to the FDA.
- Drug interaction information gathered in one section.
- A final section that prompts doctors on what keys facts they should relay to patients.
'Sometimes less is more'
The revised labels should be more concise than labels of old, but FDA officials hope the reduced warning information will have more of an impact.
"Sometimes less is more — less information, but highlighting it in a better way, sometimes better conveys important risk information," said Dr. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
The reduction in warning information had sparked concern among pharmaceutical companies worried it would open them up to greater liability, said Dr. Rachel Behrman, deputy director of the FDA's office of medical policy.
Apparently to assuage that fear, the FDA articulated in its preamble to the rule the agency's previous policy position that federally approved prescription drug labels pre-empt state liability laws. That has upset some state officials.
"This attempt to insert pre-emption language is a thinly veiled attempt on the part of FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling," National Conference of State Legislatures president Steve Rauschenberger wrote Health and Human Services Secretary Mike Leavitt in a letter Friday.