Site Engagement Program (SEP)
FDA is establishing a voluntary program which seeks to encourage quality practices at selected drug manufacturing sites with the goal of ensuring the availability of quality pharmaceuticals. FDA is conducting a limited introduction of this concept based on the idea that enhanced interaction between the Agency and identified sites will help to prevent or mitigate shortages of certain finished drug products that, if supply is disrupted, would result in higher risk to patients. The program also offers identified sites an additional opportunity to gain clarification on FDA’s expectations for pharmaceutical quality. Sites identified for this program will be asked to voluntarily agree to one or more meetings with FDA. This program was mentioned in FDA Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations
The following questions and answers provide more details about the program:
1. What is the purpose of the engagement meetings?
The purpose of this engagement meeting is to create an open line of communication between the FDA and the drug manufacturing industry that encourages discussion and resolution of both organizations’ concerns in an effort to mitigate or prevent future CGMP production problems.
2. What is the focus of the program?
The initial introduction of this program is primarily focusing on sites whose quality issues are more likely to disrupt the availability of commercial drug products vulnerable to shortage.
3. Is this program voluntary?
This is a voluntary program, but we encourage participation. The information gained from this program will be documented in FDA information systems.
FDA will not consider a decision not to participate as an inspection refusal.
4. What factors are considered for identifying a site?
The program is limited to sites identified based on the following factors:
- A firm that manufactures finished drug products that, if supply is disrupted, would result in higher risk to patients.
- A firm that was subject to an inspection between FY17 and FY18 and is not currently involved in an adverse regulatory action, e.g., a warning letter.
5. How will firms be notified?
FDA will communicate with identified firms initially by phone followed by a formal invitation letter.
6. Can sites submit questions prior to the meeting?
Yes, we strongly encourage firms to submit questions at least two weeks in advance of the meeting.
7. If my site decides not to participate, will this information be public?
The program is in an introductory stage. During this stage, FDA will not publicize or release any information that would identify a specific site or product. FDA will retain information about the requests and meetings; however, the Agency will protect this information from public disclosure just as we do information gathered on an inspection. FDA does not publicly disclose commercial confidential information, such as via FOIA. FDA will reevaluate what information might be appropriate to make publicly available if this becomes a permanent program.
8. What are the benefits of this program?
A site may benefit from an opportunity for discussion and collaboration on manufacturing issues that could impact drug product quality, availability, and ultimately patient care. Open and comprehensive dialogue leading to effective corrective or preventive action may reduce the frequency and/or the duration of an on-site surveillance inspection.
9. What is the expected timeframe for the engagement?
The timeframe for engagement will be discussed during the initial engagement meeting. The FDA believes that the maximum benefit will be obtained by having mutually agreed upon ongoing communication.
10. Will this impact pending applications?
These engagement meetings are not intended to directly impact pending applications. However, identified sites may benefit from the knowledge gained during the engagement to improve the preparedness of sites named in applications pending approval.
11. Can my firm/site still be subject to regulatory action while in this program/ pilot?
The site engagement program is meant to be collaborative and provide useful guidance consistent with existing FDA policies that are applicable to the sites operations and challenges to ensure that firms remain self-compliant. Participation in this program does not preclude the Agency from using other regulatory means to gain a site’s conformance to quality requirements and recommendations, including advisory, administrative, and judicial actions FDA deems necessary to protect the public health.
12. How will FDA measure success of this program?
Success will be measured initially by participation, level of engagement, evaluation of participant’s feedback, and realized quality improvement related to the efforts of the Agency and the site.