FDA Announces New Prescription Drug Information Format

Those pages full of tiny type that come along with prescription medication will have to be revised to make them more understandable starting June 30, 2006.

The US Food and Drug Administration (FDA) announced this week that pharmaceutical companies will have to make changes to the "package insert" that has all the legally required information about the drug for physicians, pharmacists, and consumers. It's the first revision in more than 25 years.

The major changes, according to the FDA's press release include:

A new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks.

Table of Contents for easy reference to detailed safety and efficacy information.

The date of initial product approval, making it easier to determine how long a product has been on the market.

A toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects.

The press release also said:

The most notable change is the addition of a summary outlining the most important information about a product, prominently displayed at the top of the page. Designed to help healthcare professionals find the information they need quickly, Highlights will typically be half a page in length and will provide a concise summary of information about specific areas including: Boxed Warning, Indications and Usage, and Dosage and Administration; and will refer the healthcare professional to the appropriate section of the Full Prescribing Information. In addition, drug makers will be required to include a list of all substantive recent changes made within the year, to ensure healthcare professionals have immediate access to the most up-to-date information about the product before prescribing it.

The addition of a new Patient Counseling Information section places greater emphasis on the importance of communication between professionals and patients. This new section is designed to help doctors advise their patients about important uses and limitations of medications. It will also serve as a guide for discussions about the potential risks involved in taking a specific treatment and steps for managing those risks. If FDA has approved patient information for a prescription drug, it will be printed at the end of the label immediately following the Patient Counseling Information section or will accompany the label so it can be easily shared.

More detailed information about the changes can be found at: http://www.fda.gov/cder/regulatory/physLabel/default.htm

Unfortunately, for those of us looking for lactose on the label nothing will change. As far as I can determine, the list of inactive ingredients will not be part of the new Highlights section. You'll still have to search down into the fine print to the section called DESCRIPTION to see the fillers and additives.

Overall, the new format is being hailed as a great improvement in ease of understanding. Other aspects of the reform, especially those limiting patients' ability to sue in state courts, are being widely attacked by consumer groups, though. I'll be monitoring the status of the new rules over the next six months to see if this pressure results in any changes before the revisions go into effect.