FDA Revises Prescription Drug Information Inserts

The Food and Drug Administration said Wednesday that it was overhauling the inserts packaged with prescription drugs to make the information easier to understand.

Officials hope that the new emphasis on “highlights” about a drug’s risks and benefits, along with simpler language and clearer graphics, will decrease confusion that can lead to errors in prescribing and administering medication. Such mistakes result in about 300,000 instances of preventable death and injury in hospitals each year, according to the FDA.

“Over the past decade, prescribing information has grown more and more complex, more and more dense and more difficult to negotiate,” the acting FDA commissioner, Dr. Andrew C. von Eschenbach, said Wednesday at a news conference.

Dr. Janet Woodcock, the FDA’s deputy commissioner for operations, compared the package inserts to the food labels that helped make nutritional content easier for consumers to understand.

Surgeon General Richard H. Carmona said the changes were needed to cut down on small-print warnings that made labels unreadable.

“Prescription drug information reads like drug disclaimers. We can’t do that anymore,” Carmona said.

But state officials are upset that the revision -- the first change in package inserts in more than 25 years -- includes language stating that federally approved labels preempt state product liability laws.

FDA officials said they included that language to allay the concerns of pharmaceutical companies, which worried that removal of some of the fine-print warnings on the revised inserts would open them to legal action.

Democrats and consumer advocates fear that the FDA’s language could undermine lawsuits against pharmaceutical companies. They said that companies could argue they did not have to warn consumers about certain risks if the FDA decided that those risks did not warrant inclusion on the insert.

“It’s a typical abuse by the Bush administration -- take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry,” Sen. Edward M. Kennedy of Massachusetts said Wednesday in a written statement.

Anticipating the rule, the president of the National Conference of State Legislatures, Steven J. Rauschenberger, wrote to Health and Human Services Secretary Mike Leavitt on Friday, calling the language a “thinly veiled attempt” by the FDA to “confer authority it does not have.”

“Where is the authority to preempt state law?” Joy Johnson Wilson, the conference’s health policy director, said Wednesday. “It is not settled law.... They put it in this rule to make it look like it’s settled law.”

The changes in the package insert, which will be phased in over the next seven years, take effect in 120 days and will apply to all new drugs and those approved in the last five years.