For the first time in 25 years, the Food and Drug Administration (FDA) is
requiring a major revision to the format of information in prescription drug
Effective in June, any new agent and any new indication for a drug already
on the market must include the newly reformatted labeling.
Moreover, labeling for all drugs approved within the last five years will
be reformatted according to a phase-in schedule: labels for drugs approved
within the last three years will have three years to conform to the new
format, according to Thomas Laughren, M.D., director of the Division of
Psychiatry Products at the FDA's Center for Drug Evaluation and Research.
Those drugs approved between three and five years ago will have a longer
time before the new labeling will be required, Laughren told Psychiatric
Laughren said the labeling change is the result of several years of
discussion with industry and clinicians about the increasing complexity of
information in package inserts for prescription drugs.
"We have held a number of focus groups with physicians and public
meetings and have solicited written comments from groups including the
pharmaceutical industry," he said. "We have gotten some feedback
that the existing labeling has gotten too complicated, too long, and too
difficult to find important information."
The most prominent change in the labeling requirement is the addition of a
section titled "Highlights."
"This is a half-page summary at the start of the labeling that
summarizes key information, including a black-box warning if there is
one," Laughren said.
In addition, the new labeling will include a table of contents following
the "Highlights" section that will have hyperlinks to the
pertinent text referenced in the table. The latter is an accommodation to the
movement toward e-prescribing.
"The hyperlinks should make it particularly easy for clinicians to
find pertinent information as we move into the electronic era," Laughren
said. "What we have learned from clinicians in their comments to us is
that the way they use the labeling is as a reference source—that is,
they tend to go to the specific section that has the information they need.
The hyperlinks will allow prescribers to do just that."
According to information about the labeling change on the FDA's Web site,
black-box warnings—such as those required on medications for
ADHD—will still appear in the labeling even though the warnings are
summarized in "Highlights."
"As with all information in `Highlights,' the boxed warning... is a
summary, not a duplication of the full boxed warning in the full prescribing
information," according to the FDA. "It typically will be in a
bulleted format, limited to 20 lines, and will refer to more detailed
information, including the complete boxed warning and other sections of the
FPI. Because `Highlights' is one-half page in length and the table of contents
follows, [the boxed warnings in `Highlights'] will rarely, if ever, appear on
the same page of the prescribing information as the full boxed warning. The
FDA believes a summarized boxed warning in `Highlights,' with references to
more detailed information, is the most effective way to communicate critical
safety information to health care professionals."
Laughren said he did not foresee any changes to labeling that were specific
to products for psychiatric patients beyond those changes that will be
applicable to products prescribed by all clinicians.
Other significant changes, in addition to the "Highlights"
section and the table of contents, are easy access to the date of initial
product approval, making it easier to determine how long a product has been on
the market, and inclusion of a toll-free number and Internet reporting
information for suspected adverse events. This is an attempt to encourage more
widespread reporting of suspected side effects.
Other government officials agree with Laughren that the new labeling is
aimed ultimately at reducing medication errors.
"Providing health care professionals and patients with clear and
concise information about prescriptions will help ensure safe and optimal use
of drugs, which translates into better health outcomes for patients and more
efficient delivery of health care," said Mike Leavitt, secretary of
Health and Human Services, in a statement about the labeling change. "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."
More information about the labeling change is posted at<www.fda.gov/cder/regulatory/physLabel/default.htm>.▪