In its first major overhaul of prescription drug labeling information in 25 years, the Food and Drug Administration (“FDA”) announced last week changes to the content and format of the package insert for human prescription drugs and biologic products. FDA adopted these substantial revisions in an effort to decrease medical errors by providing health care practitioners and patients with current medical information in a concise format. Ultimately, this final rule will require the manufacturers of many drugs to implement significant changes to the package insert.

The most important revision to the prescription drug labeling information is the inclusion of a “Highlights” section in the package insert. This section must present a concise summary of the most important prescribing information about a drug, including Boxed Warning, Indications and Usage, Dosage and Administration, and Warnings and Precautions, and a list of all substantive, recent changes made to these categories within the past year. This section also must include the initial approval date of the original drug product and adverse reaction report contact information, including a toll-free number and Internet address. The Highlights section is expected to be approximately ½ page in length.

Under this rule, drug manufacturers also must include a new “Patient Counseling Information” section in the package insert. This is added to the requirement that all FDA-approved patient information must be reprinted in, or accompany, the drug product’s package insert. FDA believes that this section will enhance the prominence of patient information, which should increase communication between health care practitioners and patients.

This new rule is scheduled to take effect on June 30, 2006. It will apply initially to newly and recently approved prescription drugs and to those drugs that receive approval for new indications. FDA published four guidance documents to assist drug manufacturers in complying with the new content and format requirements. These guidance documents focus on the information that should be presented in the Highlights, Adverse Reaction, Clinical Studies, Warnings and Precautions, Contraindications, and Boxed Warning sections of the package insert.

FDA intends to integrate this new prescription drug information format into its other e-Health initiatives. For example, the National Institutes of Health will add this updated prescription drug information to the DailyMed Web site, a new, interagency online health information database designed to provide the most current medication information free to patients and health care practitioners.

Finally, the most surprising change appears in the Preamble to the Agency’s Final Rule. In this section, FDA indicates that state tort laws concerning the labeling of prescription drugs should, in most instances, be completely preempted. FDA believes that approval of labeling during the NDA process preempts all conflicting or contrary state laws, regulations, or any jury consideration of these matters. The agency states that preemption would include claims against both manufacturers and health care practitioners. For further review of the preemption discussion, please see our earlier client alert at http://www.arentfox.com/legal_updates/content1201.html.

Links to the Final Rule and Guidance Documents:

Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, Effective June 30, 2006.
Part 1: http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1269-nfr0001-01.pdf
Part 2: http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1269-nfr0001-02.pdf
Part 3: http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1269-nfr0001-03.pdf

Guidance for Industry:

• Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products – Content and Format.
  http://www.fda.gov/cder/guidance/5537fnl.pdf
• Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products – Content and Format.
  http://www.fda.gov/cder/guidance/5534fnl.pdf
• Labeling for Human Prescription Drug and Biological Products – Implementing the New Content and Format Requirements (Draft).
  http://www.fda.gov/cder/guidance/6005dft.pdf
• Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products – Content and Format (Draft).
  http://www.fda.gov/cder/guidance/5538dft.pdf

Should you have any questions concerning FDA’s new requirements for prescribing information, please contact Amy Swift, Wayne Matelski, or Brian Waldman of the firm’s Food and Drug Practice:

Amy Swift
202.857.6338
swift.amy@arentfox.com

Wayne Matelski
202.857.6340
matelski.wayne@arentfox.com

Brian Waldman
202.857.8971
waldman.brian@arentfox.com