FDA unveils new prescription drug labels that doctors and patients should understand
Thursday, January 19th 2006, 10:04 am
By: News On 6
WASHINGTON (AP) _ A major makeover is coming for the little written inserts that accompany prescription drugs. The new versions are supposed to play up information that's useful to pharmacists and patients while paring down the small-print legal disclaimers.
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, Surgeon General Richard Carmona said Wednesday in introducing the new drug labeling rules.
The rules should make it easier to quickly learn the most critical things about a drug, according to the Food and Drug Administration.
But the FDA's repeated assertions that the federally approved labels pre-empt state law alarmed some activists and legislators, who call that a curtailment of patient rights. The rules come amid a flurry of high-profile drug lawsuits, including cases involving Merck & Co.'s painkiller Vioxx.
The guidelines seek to roll back additions made over the years that have made prescription drug inserts, intended for physicians but useful to patients, dense and difficult to negotiate, acting FDA commissioner Dr. Andrew von Eschenbach told a news conference.
``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 American Medical Association applauded the FDA, saying it had long encouraged the regulatory agency to make labels more useful and user-friendly.
Patients should benefit as well.
``We have hit a point of information overload and the public health message is being diluted,'' Carmona said. ``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. Driven in part by the liability concerns of pharmaceutical companies, labels have turned into ``disclaimers rather than important public health tools,'' said Dr. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
The new rules remove many of the legal warnings and move further to the back the diagrams of each drug's chemical structure that long have introduced the densely written pamphlets.
In their place will be more up-to-date and easy-to-read information, including a box of ``highlights'' that spell out a drug's risks and benefits. The labeling information also will include novelties like a table of contents.
Doctors and pharmacists still should read the inserts to the end, said Frank Palumbo, a pharmacist and attorney who heads the University of Maryland's Center on Drugs and Public Policy.
``I don't think a prescriber should prescribe something unless they've familiarized themselves with a product,'' Palumbo said.
The reduction in warning information had sparked concern among pharmaceutical companies worried it would open them up to greater liability. Apparently to address that, the FDA staked out the agency's position that federally approved drug labels pre-empt state liability laws.
``State law actions also threaten FDA's statutorily prescribed role as the expert federal agency responsible for evaluating and regulating drugs,'' the rule reads in part.
That sparked immediate concern that the FDA was seeking to curtail patient rights. The president of the watchdog group Public Citizen, Joan Claybrook, called it a ``sneak attack.''
Sen. Edward Kennedy, D-Mass., said: ``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.''
All new drugs approved after the rule takes effect June 30 will have to include the new labels. Use of the labels will be phased in for those drugs approved within the last five years, as well as those now under FDA review, Woodcock said.
The new drug labels will also 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.