Recently, the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP), which was formerly the Division of Drug Marketing, Advertising and Communications (DDMAC), announced a process to evaluate promotional materials known as “Launches.”
As OPDP explained, “Launches are draft promotional materials that are voluntarily submitted (unless otherwise required for submission, such as per Subpart H or E regulations) by a sponsor to OPDP during the launch phase (i.e., the first 120 days that an FDA-approved product is marketed to the public) for review and comment prior to first use in the public domain.
This means that after submitting draft launch material, a sponsor should not disseminate the same or similar claims while our review is pending.
A launch submission occurs when a sponsor decides to seek advisory comments from OPDP after the Agency approves a new drug, indication, delivery system, formulation, or route of administration.
Requesting advisory comments on launch promotional materials prior to use is strongly encouraged by OPDP. Review of core launch materials is a high priority for OPDP reviewers.
Sponsors with drugs approved under Subpart H and biologic therapeutic products approved under Subpart E are required by regulation to submit all promotional materials in advance of use, including launches. Any promotional materials intended to be used in the first 120 days after approval must be submitted to OPDP before the product is approved.
Core launch materials
OPDP noted that core launch materials generally include:
- One comprehensive professional labeling piece (e.g., sales aid, visual aid, or detail aid; exhibit panel if there is a major conference within the launch phase) limited to 12 or fewer pages
- One professional advertisement (e.g., journal ad) limited to four or fewer pages, not including the PI or brief summary
- One comprehensive direct-to-consumer labeling piece (e.g., patient brochure) limited to 12 or fewer pages
- One direct-to consumer advertisement (e.g., magazine ad) limited to four or fewer pages, not including the PPI or brief summary
- Professional and direct-to-consumer product web page (limited to 12 printed PDF pages each) that is a derivative of the comprehensive labeling piece, if one was submitted
OPDP noted that “other promotional materials such as slide kits, reprints, and monographs are not considered core launch materials.”
The goal timeline for review within OPDP (minus the time required for medical officer consult) is within 45 days of receiving the submission.
Non-core launch materials
Materials other than those listed above are considered non-core launch materials. Note that non-core materials are a lower priority for OPDP than core launch materials. OPDP recommends applying the comments on the core materials to non-core materials.
Requesting comments on draft launch promotional materials
OPDP noted that manufactures should include the following in the submission:
- Cover letter requesting OPDP comments on draft launch materials.
- Include “Request for Launch Advisory Comments” in the subject line of the cover letter
- List each promotional piece individually in the cover letter and note which pieces are core materials (see definition above)
- Include the material type (2253 code) for each piece in parenthesis on the cover letter. This list of codes is available on the FDA Form 2253. Draft launch materials are not submitted on 2253.
- Draft promotional materials including annotations to references
- Annotated supporting references
- Annotated current Package Insert/Medication Guide/Patient Package Insert. Note that the annotated product labeling should be approved or essentially final at the time of the submission. Do not submit a draft PI that is not essentially final. The submission is not reviewable if the PI is not essentially final.
- OPDP cannot provide advisory comments on claims that are in the public domain. If you want advisory comments, do not use promotional pieces with the same or similar claims and presentations as the claims and presentations in the draft materials submitted for advisory review. If you choose to use promotional materials with the same or similar claims or presentations, please let OPDP know immediately so that we can stop the advisory review.
Number of copies included in the advisory request submission
Sponsors must submit 3 copies of all the materials except for Launch DTC TV ads, which require 17 copies.
These submissions to OPDP should be sent to the FDA central document room at the following address:
Professional Directed Materials:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion
Division of Professional Promotion
5901-B Ammendale Road
Beltsville, MD 20705-1266
Consumer Directed Materials:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion
Division of Direct-to-Consumer Promotion
5901-B Ammendale Road
Beltsville, MD 20705-1266
To help avoid misdirection of promotional materials, OPDP suggests applying a “OPDP” sticker or other prominent directional notation to the package exterior. If it is not possible to add this notation to the exterior of the package, OPDP recommends adding a prominent directional notation (e.g., sticker, rubber stamp, etc.) to the cover letter itself. Please do not submit desk copies to other divisions within FDA.