Information and Resources

FDA to Simplify Drug Safety Labels

Jan. 18, 2006 -- Doctors will soon see easier-to-understand safety labels on prescription drugs, the FDA announced Wednesday.

New rules unveiled by the agency will force drugmakers to simplify the informational inserts that now come with most prescriptions. Agency officials say the move was designed to simplify use instructions and side effect warnings in a bid to make medications safer to use.

The changes don't directly affect consumer drug information, prompting criticism from an FDA watchdog group.

The move comes as the FDA continues to revamp some of its safety practices for newly approved and already marketed drugs. The shuffles stem from several widely publicized safety problems, most notably an increased risk of heart attacks and strokes that led manufacturers to pull the painkillers Vioxx and Bextra from the market.

Prescription package inserts have faced some criticism for being overly packed with information that was difficult to decipher. FDA officials regularly acknowledged that most doctors rarely read safety labels.

Wednesday's move, due to take effect in four months, will now simplify labels by placing the most important safety warnings and usage instructions at the top of the sheet. New labels will now start by clearly listing contraindications, common side effects, potential drug interactions, and other precautions at the label's start.

"We're dependent upon medical information that is presented in a fashion and a format that is difficult to use effectively and appropriately," says Andrew von Eschenbach, MD, the FDA's acting commissioner. The new rules will "eliminate much of the clutter" found in current drug labels, he explains.

Drugs approved within the last five years and any newly marketed drugs will have to carry the new labels.

"We're launching today a totally new look for the prescription label," says Janet Woodcock, MD, the FDA's deputy commissioner of operations. "This is what doctors ask us for."

Changes Attacked

The American Medical Association, the nation's largest doctor's group, applauded the draft rules but says it will wait to see the final form. "We hope that the new prescription drug information format will help physicians better access and communicate important drug information to their patients," the group says in a statement.

But the changes were attacked by the FDA watchdog group Public Citizen for failing to boost policing of information leaflets targeted to consumers. Those leaflets often don't focus on the most important safety information, the group says.

"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," Sydney Wolfe, MD, director of Public Citizen's Health Safety Group, says in a statement.

The provision also sparked a reaction on Capitol Hill. "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 Kennedy (D-Mass.), the ranking member of the committee with jurisdiction over the FDA, says in a statement.

Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, told reporters that the provision was included because cluttered drug labels had become disclaimers rather than important public health tools and that the labels needed to be "reclaimed" for doctors and patients.

"We haven't relinquished or diminished any of our standards," von Eschenbach says.