January 20, 2006
FDA unveils new prescription drug label format
Package inserts are getting a major makeover in an effort to give doctors and patients more concise prescribing information, the FDA announced Wednesday.
“The new label design makes it easier for doctors to get access to important information about drug safety and benefits, and this in turn will help them have more meaningful discussions with their patients,” said Andrew von Eschenbach, acting FDA commissioner. However, the reduction in label warning information has sparked concern among pharmaceutical companies worried that the new format could open them up to greater legal liability.
To quell this fear, the FDA stated in its preamble statement to the changes that it would retain its policy that federally approved prescription drug labels pre-empt state liability laws.
That move has upset some state lawmakers.
“This attempt to insert preemption language is a thinly veiled attempt on the part of FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling,” said Illinois state senator Steve Rauschenberger, president of the National Conference of State Legislatures, in a letter to US Department of Health and Human Services secretary Mike Leavitt.
The new drug labeling requirements will be phased in gradually applying to newly and recently approved prescription drugs and those that receive approval for new uses, the FDA said.
“This redesigned label is a big step in our commitment to giving health professionals the tools and information they need to optimize their clinical practice and choose among a growing number of effective treatments to make more personalized prescribing decisions for their patients.”
The new format, the first in more than 25 years, requires that the prescription information for new and recently approved products meet specific graphic requirements and includes the reorganization of critical information so physicians can find the information they need quickly.
Highlights from the changes include:
*A new “highlights” section provides immediate access to the most important prescribing information about benefits and risks.
*A table of contents gives easy reference to detailed safety and efficacy information.
*The appearance of the date of initial product approval makes it easier to determine how long a product has been on the market.
*A toll-free number and Internet site is listed for reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects.
According to the FDA, the new initiative will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources.
“This revised prescription information format, in combination with new requirements for electronic labels announced earlier this month and requirements for bar codes on drugs, will dramatically improve the way healthcare professionals and consumers obtain information about prescription drugs,” added von Eschenbach.
The agency is encouraging drug makers to consider complying with the new labeling requirements earlier on a voluntary basis. All drugs approved within the past five years are included, and they will gradually be converted to the new format.