Office of Prescription Drug Promotion (OPDP) Launches
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 for drugs approved under Subpart H and biologic therapeutic products approved under Subpart E intended to be used in the first 120 days after approval must be submitted to OPDP before the product is approved.
Core launch materials
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) or electronic Sales Aid that is a derivative of the comprehensive labeling piece, if one was submitted
- 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
Requesting comments on draft launch promotional materials
- Please consolidate draft core launch materials into a single submission for each intended audience (i.e. one submission for professional materials and one submission for consumer materials) rather than sending the material piecemeal in several submissions over the course of a few days/weeks.
- Submit non-core draft launch materials in a separate submission from the draft core launch materials. Submit separate submissions for each intended audience.
- In cases when professional and consumer core launch materials will be submitted around the same time, please submit both submissions on the same day. This will allow both submissions to have the same 45 day goal.
- 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. Note whether the submission is a submission of core launch 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.
- Include contact name, title, address, phone, fax, and email of the person that OPDP should contact about issues related to the submission
- 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.
- Do not disseminate the same or similar claims and presentations prior to or while OPDP review is pending. If OPDP learns that the submitted materials, or substantially similar claims and presentations, are in the public domain, OPDP will generally not review the materials under the advisory process. 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
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion
5901-B Ammendale Road
Beltsville, MD 20705-1266
To help avoid misdirection of your promotional materials, OPDP suggests applying a "OPDP" sticker [example sticker (PDF)] 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. If you would like to provide additional copies, please include them directly in your submission to OPDP.
Note: For any time sensitive materials, please confirm receipt of the submission by OPDP with a phone call to the OPDP project manager at 301-796-1200.For questions regarding this information, please email CDER-OPDP-RPM@FDA.HHS.GOV.