Goal of drug labeling rule is clearer inserts

Washington -- The Food and Drug Administration's long-awaited prescription drug labeling rule was unveiled Jan. 18, and with it came hope that long and complex package inserts will be replaced with physician-friendly inserts that highlight the essentials -- dose, risks, contraindications and potential drug interactions.

The new rule is intended to give clear and concise prescribing information, according to FDA officials. This information is to be provided in an easy-to-read format with the most important data in a prominent half-page "highlights" section at the top.

The rule takes effect June 30 for new drugs. Drugs approved during the previous five years will be gradually phased in, and older drugs will be included only if there has been a major change in prescribing information.

Physicians long have criticized the lengthy package inserts that have morphed over the past decade from useful tools into lengthy and complex legal documents. The superabundance of material they contained often overshadowed the data physicians needed to find quickly.

The AMA applauded the new rule.

"We hope that the new prescription drug information format will help physicians better access and communicate important drug information for their patients," said AMATrustee Edward Langston, MD.

"The AMA has long encouraged the FDA to update the prescription drug package insert to make information more useful and user-friendly to physicians," Dr. Langston said. The Association has testified before Congress and before the FDA about the need for such improvements.

The new labels also are being eyed by the agency as a way to improve patient safety. "By improving the package insert to make it more useful for health care providers in their day-to-day clinical practice, we are making it easier for them to explain the benefits and risks of medications for their patients," said Health and Human Services Secretary Mike Leavitt.

The labels will include a table of contents to allow quick access to detailed information, the date of the initial product approval and a toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects.

In addition, drug manufacturers will be required to include a list of all substantive changes made within the previous year to ensure that physicians are provided with the most up-to-date information about a product.

The new labels also will be coordinated with an FDA requirement instituted last November that drug manufacturers submit prescription drug labeling information in electronic format. Using embedded computer tags and standardized medical terminology, the new format is intended to allow physicians to quickly search and access specific prescribing information that should reduce medication errors, agency documents said.

Critics cite concerns

But not everyone has hailed the rule's arrival. Some groups point to a clause in the rule's preamble that, they say, could negate state product liability laws regarding prescription drugs.

This preemption potentially could leave people who believe they have been harmed by a drug with no legal remedy in state courts, said Sidney Wolfe, MD, director of Public Citizen's Health Research Group, a Washington, D.C., advocacy group.

"This attempt to insert preemption language is a thinly veiled attempt on the part of the FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling," said National Conference of State Legislatures President and Illinois State Sen. Steve Rauschenberger, a Republican, in a letter to Leavitt.

Dr. Wolfe also faulted the new rule for failing to provide the same quality of information to patients as it does to physicians. Currently, patient materials are supplied by the manufacturers without FDA scrutiny, he said, and that will continue.

"The agency has the authority to require agency-approved 'medication guides' for each new prescription and refill but has done so for only about 75 drugs," said Dr. Wolfe.

The IOM examines drug safety

Meanwhile, at the request of the FDA, the Institute of Medicine has been meeting for the past year to assess the nation's drug safety system and provide guidance for improving the agency's safety record.

During a Jan. 19 meeting, the IOM panel of physicians, pharmacists, economists and others heard testimony from representatives of pharmaceutical companies and advocacy groups.

"At its root, the system depends on trust," said Geoffrey Levitt, vice president for regulatory affairs and research at Wyeth Pharmaceuticals. "And it's clear that trust has been eroded."

Levitt recommended looking critically at how the safety issue is being addressed by determining "what went wrong and why."

"Although market withdrawal of an approved drug is always traumatic," he said, withdrawals are rare. The agency gets it right more than 97% of the time, he added, indicating that the drug approval system isn't broken.

"Every time you open the paper, there is something about drug safety," said James Nickas, PharmD, senior director for development at Genentech. When examining recent high-profile cases such as suicide ideation among teens prescribed antidepressants or the withdrawals of Vioxx and the multiple sclerosis drug Tysabri, each had a different problem which requires a different solution, he said.

Frank Burroughs, president of the Abigail Alliance, a Virginia-based advocacy group for cancer patients, urged the IOM panel to consider providing earlier access to investigational drugs for cancer patients who have exhausted FDA-approved therapies. "The issue of safety and risk is very different for cancer patients and others with life-threatening illnesses than for patients with less-serious ailments," Burroughs said.