- Regulatory & Scientific Affairs
- Government Affairs
- Statistical Task Force
- Ethics & Compliance
- CDC Healthy Contact Lens Wear and Care Project
- Communications and Issues Management
Regulatory & Scientific Affairs Committee
The purpose of this committee is to help assess and develop plans of action on issues primarily related to FDA and Standards that may impact the Contact Lens and Lens Care Industry.
Some current key focus areas include: scheduled periodic face-to-face meetings with FDA and Committee members to discuss industry issues; recommending changes to FDA Contact Lens and Lens Care Guidance Documents; submitting and presenting Comments at FDA Panel meetings; developing a standardized adverse event decision tree for MDR reporting; determine appropriate ways for industry to comply with new UDI labeling requirements and take steps for any needed exemption or exception reporting; and participation in ANSI and ISO by conducting ring tests and publishing new test methods in the E&CL Journal, as well as collaborating on standards development.
The Government Affairs Committee’s focus is on Federal and State legislative proposals that impact the industry’s ability to successfully carry out its business model; and, will proactively respond to prevent/mitigate negative impacts, and support proposals that positively impact the industry’s business model.
The Committee will work closely with the other Contact Lens Institute Committees (primarily Regulatory and Ethics & Compliance) to provide legislative guidance toward potential, realistic legislative solutions to onerous regulations when possible. The Committee will also monitor and coordinate with the work of the AdvaMed Ophthalmic Section, as well as the AdvaMed Government Affairs Committee when possible, appropriate and relevant for the U.S. Contact Lens and Lens Care Industry.
The members of the CLI, together with other participating companies participate in a quarterly statistical program to track manufacturer shipment data of Contact Lens and Lens Care products which is managed by Veris Consulting.
The program’s objective is to provide participants with accurate and timely consolidated market data while maintaining the confidentiality of each participant’s individual data. Each participating company in the CLI Statistical Program has a representative on the CLI Global Statistical Task Force. The Task Force determines all the rules guiding the statistical program, such as what data will be collected, reporting instructions, definitions, disclosure guidelines, etc. The Task Force meets in person on a regular basis, and holds additional conference calls as needed to address program issues. In addition to the Global Task Force, there are Japan and Asia-Pacific Task Forces that may meet periodically, in person or by conference call, to discuss issues and make recommended changes to the procedures and formats pertaining to CLI reports for these regions
This Committee undertakes activities related to ethics and compliance matters that face the U.S. Contact Lens and Lens Care Industry. The Committee is focused on Sunshine Laws, Ethics Code Implementation and Anti-bribery provisions that impact the Contact Lens and Lens Care Industry. The Committee’s initial focus will be on reviewing how AdvaMed and PhRMA ethics guidelines are being interpreted by our industry and the ophthalmic community and, where necessary and appropriate, proactively seeking to clarify how the guidelines apply to our industry and to educate the ophthalmic community with respect to the guidelines.
CLI is currently funding a Center for Disease Control (CDC) project related to Healthy Contact Lens Wear and Care. CDC has hired a health communication specialist and part-time web developer that is guided by a newly created Working Group that includes two CLI members. The specialist will develop contact lens-related health promotion activities and materials for CDC including a new microbial keratitis section on CDC’s vision web area. Creation of such a health promotion focus would elevate this issue to include multiple pathogen specialties and provide needed visibility for microbial keratitis prevention efforts and CL use. This activity will engage partners from the FDA, CL manufacturers, CL solution manufacturers, optometry and ophthalmology organizations, and other health groups in creating and promoting healthy CL hygiene and use. The multi-platform approach is intended to include website content, integration with industry package directions, provider education materials, and media interaction. Health promotion activities will also include promoting media events (e.g., healthy CL use week) that raise awareness of the importance of proper CL care activities for healthy eyes. The working group, including a dedicated health communications specialist, focused on promoting healthy CL use contact lenses could lead to increased understanding of the proper role of hygiene and a reduced risk of microbial keratitis. CDC believes that CL wearers can be made aware of the critical role that hygiene plays in a healthy lifestyle, leading to a better CL-wearing experience. Promoting healthy CL care could be beneficial to the CL lens industry, leading to improving wear experience. CDC is in a unique position to promote healthy CL lens use and hygiene as a non-regulatory, credible, and impartial public health agency.
Communication & Issues Management Committee
The Committee is comprised of representatives from the Professional Affairs, Public Relations and Compliance Officers of member companies. This Committee, through a Core Team, will be involved in the decision-making process related to all issues for which a CLI response is being considered. When deemed necessary or upon request from any Board Member, the Core Team will access the expertise and input of other CLI Board members and advisors. In some cases the Team may decline to respond and defer to the appropriate manufacturer, vendor and/or professional. The definition of a “CLI Related Issue” is provided in the CLI Issues Management Procedure. To ensure rapid, accurate and professional response to media and other inquirers on CLI Related Issues, a standard protocol has been established in the procedure. In some cases, because of the situation or nature of the issue, the protocol may be modified. In these cases, one key member of the Core Team may serve to coordinate the flow of information.