Post-Marketing Commitments / Post-Marketing Requirements
Advancing science and providing quality healthcare options for patients entails comprehensive research demonstrating the efficacy and safety of pharmaceutical products. At times, additional studies are performed to determine supplementary product detail. As part of the U.S. Food and Drug Administration (FDA) Regulatory approval process for marketed products (i.e., drugs or biologics), companies may agree or be required to conduct additional studies and testing following the approval of a medicine. These additional studies are known as Post-Marketing Requirements (PMRs) or Post-Marketing Commitments (PMCs).
PMRs are studies and clinical trials that sponsors are required to conduct under one or more statutes or regulations, and PMCs are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statute or regulation. PMCs/PMRs are used to gather additional information about a product’s safety, efficacy, or optimal use, such as information regarding the product’s pharmacokinetics and pharmacodynamics, new dosage forms, and use in pediatric or other special populations, among other parameters. There may be more than one PMC/PMR for any particular product. The Amgen website lists the clinical and other studies comprising the PMCs/PMRs related to the safety, efficacy and use of Amgen’s products. Also, this site lists PMCs/PMRs only for those products Amgen, or one of its wholly-owned subsidiaries, is the sponsor holding the U.S. regulatory approval for the medicine.
Below are the column headings and explanations of terms found in the attached PDF file of Amgen’s PMCs/PMRs:
|Product Name (Brand Name/Generic Name)||Tradename used in the US market|
|Application Number||FDA assigned number|
|Commitment Date||The date when Amgen has agreed to a final submission relating to the PMC/PMR|
|PMC/PMR Identifier||The PMC/PMR number assigned by FDA|
|PMC/PMR Description||The description of the PMC/PMR|
|Status (Pending, Ongoing, Delayed, Terminated, Submitted, Fulfilled and Released)||The status of the PMC/PMR at the last quarterly update (see definitions below)|
|Explanation of Status||An explanation is provided if the PMC/PMR is delayed and includes the revised date of completion|
Amgen will update PMC/PMR information quarterly on this website. PMC/PMR for recently approved products will be added to the website at the next corresponding update.
Post-marketing Commitments/Post-marketing Requirements
Sponsors must provide annual status reports concerning open PMCs/PMRs to FDA. The annual status report is required until FDA notifies the sponsor, in writing, that all PMCs/PMRs for a given product have either been fulfilled or that the sponsor is released from the requirements/commitments. Consistent with those requirements, Amgen provides ongoing updates to the FDA regarding the status and outcome of its PMCs/PMRs, which are, in turn, posted by FDA at FDA.gov. Information regarding the PMCs/PMRs for Amgen’s products can be obtained through the FDA website by entering the name of the Amgen product in the “Product” box and then clicking on the “Search” button.
FDA.gov: Postmarketing Requirements and Commitments
Due to variations in the timing of updates, differences may occasionally appear between the status of a commitment reported on the Amgen website and the status as reported on the FDA website. In addition, while it is required that certain information concerning PMCs/PMRs be made available to the public, PMC/PMR information that is proprietary, such as information relating to chemistry, manufacturing and/or control (CMC) issues, is not made public and is, therefore, not included here or on the FDA web site.
Other Related Useful FDA links:
Postmarketing Requirements and Commitments Frequently Asked Questions (FAQs)
Postmarketing Requirements and Commitments: Status and Fulfillment Categories
The following terms and definitions are provided by the FDA to describe the status of each PMC/PMR:
Pending: The study/clinical trial has not been initiated (i.e., no subjects have been enrolled or animals dosed), but does not meet the criterion for delayed (i.e., the original projected date for initiation of patient accrual or initiation of animal dosing has not passed).
Ongoing: The study/clinical trial is proceeding according to, or is ahead of, the original schedule. The FDA considers a study/clinical trial to be ongoing until a final report is submitted to the FDA, as long as the activities are proceeding according to the original schedule. If patient accrual or animal dosing has started but is not complete, and the projected date for completion of that milestone has passed, the study/clinical trial should be categorized as delayed.
Delayed: The progression of the study/clinical trial is behind the original schedule. Delays can occur in any phase of the study/clinical trial, including patient enrollment, analysis of results, or submission of the final report to the FDA. While the original schedule—not a revised schedule—serves as the basis for defining a study/clinical trial as delayed, each phase of the study/clinical trial will be considered in its own right. If the applicant has one delayed phase, but gets back on schedule during the next phase, the delayed status will no longer apply.
Terminated: The applicant ended the study/clinical trial before completion and has not yet submitted a final report to the FDA.
Submitted: The applicant has concluded or terminated the study/clinical trial and has submitted a final report to the FDA, but FDA has not yet notified the applicant in writing that the requirement/commitment has been fulfilled or that the requirement/commitment has been released.
Fulfilled: The applicant has submitted the final report for the requirement/commitment, and, upon review of the final report, FDA is satisfied that the applicant has met the terms of the requirement/commitment.
Released: FDA has informed the applicant that it has been released from its requirement/commitment to conduct the postmarketing study/clinical trial because it is either no longer feasible or would no longer provide useful information.Advancing science and providing quality healthcare options for patients entails comprehensive research demonstrating the efficacy and safety of pharmaceutical products. At times, additional studies are performed to determine supplementary product detail. As part of the U.S. Food and Drug Administration (FDA) Regulatory approval process for marketed products (i.e., drugs or biologics), companies may agree or be required to conduct additional studies and testing following the approval of a medicine. These additional studies are known as Post-Marketing Requirements (PMRs) or Post-Marketing Commitments (PMCs).