Healthcare professionals and patients depend on Bausch + Lomb to promote its products properly and in full compliance with FDA regulations and other industry standards. All promotional claims, activities, and communications must be truthful, accurate, not misleading, well-substantiated, and aligned with the FDA-approved or cleared intended use and the corresponding FDA-mandated labeling.
Some states or municipalities require representatives to hold licenses before promoting pharmaceutical products. Colleagues working in these areas must adhere to the applicable state or local laws as well as the guidance provided by their managers. For additional details on state and municipal regulations, please refer to the Summary of Healthcare Laws section.
Healthcare professionals and patients depend on Bausch + Lomb to promote its products properly and in full compliance with FDA regulations and other industry standards. All promotional claims, activities, and communications must be truthful, accurate, not misleading, well-substantiated, and aligned with the FDA-approved or cleared intended use and the corresponding FDA-mandated labeling.
Some states or municipalities require representatives to hold licenses before promoting pharmaceutical products. Colleagues working in these areas must adhere to the applicable state or local laws as well as the guidance provided by their managers. For additional details on state and municipal regulations, please refer to the Summary of Healthcare Laws section.
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In preparation for launching a new product—such as a line extension, new indication, or new formulation of an existing FDA-approved product—Bausch + Lomb should assess and determine the necessary educational initiatives to effectively inform healthcare professionals and patients on the safe and proper use of the product. Additionally, considerations must be made to ensure access to the new product through payers, providers, insurance companies, and Healthcare Institutions (HCI). Throughout all stages of preparing for the product launch, Bausch + Lomb colleagues must strictly adhere to industry regulations and Bausch + Lomb’s policies and procedures to avoid promoting the product prior to FDA approval. Any sales, marketing, medical affairs, or related external communications concerning the new product and/or the associated disease state must obtain corporate approval through the designated Bausch + Lomb approval process before implementation. Neglecting to secure corporate approval could jeopardize the product launch and delay critical medical benefits from reaching the patients who need them.
In preparation for launching a new product—such as a line extension, new indication, or new formulation of an existing FDA-approved product—Bausch + Lomb should assess and determine the necessary educational initiatives to effectively inform healthcare professionals and patients on the safe and proper use of the product. Additionally, considerations must be made to ensure access to the new product through payers, providers, insurance companies, and Healthcare Institutions (HCI). Throughout all stages of preparing for the product launch, Bausch + Lomb colleagues must strictly adhere to industry regulations and Bausch + Lomb’s policies and procedures to avoid promoting the product prior to FDA approval. Any sales, marketing, medical affairs, or related external communications concerning the new product and/or the associated disease state must obtain corporate approval through the designated Bausch + Lomb approval process before implementation. Neglecting to secure corporate approval could jeopardize the product launch and delay critical medical benefits from reaching the patients who need them.
All Bausch + Lomb pharmaceutical drug promotional programs, activities, and related materials must align with the FDA-approved product labeling. This labeling provides details on the approved indications or intended uses, patient populations including age groups, treatment phases, and dosing regimens authorized by the FDA for the drug.
All Bausch + Lomb pharmaceutical drug promotional programs, activities, and related materials must align with the FDA-approved product labeling. This labeling provides details on the approved indications or intended uses, patient populations including age groups, treatment phases, and dosing regimens authorized by the FDA for the drug.
Colleagues must promote only truthful, non-misleading information consistent with product labeling when participating in promotional activities or interacting with HCPs and other Customers. Additionally, Colleagues must provide complete, fair balanced information about the benefits and risks of Bausch + Lomb Medical Devices, including patient safety information.
The FDA authorizes a product only for the specific uses detailed in the approved package insert. Any use outside of these approved parameters is considered Off-Label. Off-Label uses may include unapproved indications, dosage forms, dosing regimens, patient populations, unsubstantiated competitive claims, or other usage not described in the approved labeling.
Healthcare professionals may prescribe products for Off-Label uses based on their clinical judgment; however, sales colleagues are prohibited from discussing Off-Label uses of Bausch + Lomb products, even if the healthcare professional initiates the conversation. Additionally, colleagues must not solicit or encourage healthcare professionals to inquire about Off-Label uses. If asked about Off-Label use, colleagues should clarify that only the approved indications can be discussed. For further details on handling unsolicited medical information requests, please refer to the Medical Science Liaisons and Unsolicited Requests for Medical Information section of this Policy Guide.
The FDA authorizes a product only for the specific uses detailed in the approved package insert. Any use outside of these approved parameters is considered Off-Label. Off-Label uses may include unapproved indications, dosage forms, dosing regimens, patient populations, unsubstantiated competitive claims, or other usage not described in the approved labeling.
Healthcare professionals may prescribe products for Off-Label uses based on their clinical judgment; however, sales colleagues are prohibited from discussing Off-Label uses of Bausch + Lomb products, even if the healthcare professional initiates the conversation. Additionally, colleagues must not solicit or encourage healthcare professionals to inquire about Off-Label uses. If asked about Off-Label use, colleagues should clarify that only the approved indications can be discussed. For further details on handling unsolicited medical information requests, please refer to the Medical Science Liaisons and Unsolicited Requests for Medical Information section of this Policy Guide.
All Bausch + Lomb medical device promotional programs, activities, and related materials must comply with the FDA-approved or cleared intended uses and the FDA-mandated labeling. Devices marketed through the 510(k) premarket notification process are known as cleared devices. The FDA prohibits using the term “FDA approved” when describing devices brought to market via the 510(k) process. Colleagues must complete training and obtain corporate authorization before promoting any Bausch + Lomb medical devices.
All Bausch + Lomb medical device promotional programs, activities, and related materials must comply with the FDA-approved or cleared intended uses and the FDA-mandated labeling. Devices marketed through the 510(k) premarket notification process are known as cleared devices. The FDA prohibits using the term “FDA approved” when describing devices brought to market via the 510(k) process. Colleagues must complete training and obtain corporate authorization before promoting any Bausch + Lomb medical devices.
Bausch + Lomb Colleagues must promote only truthful, non-misleading information about Bausch + Lomb Medical Devices when participating in promotional activities or interacting with HCPs and other Customers. Bausch + Lomb should not deviate from the approved or cleared uses when promoting Bausch + Lomb Medical Devices. Additionally, Colleagues should provide complete, fair balanced information about the benefits and risks of Bausch + Lomb Medical Devices, including patient safety information.
During interactions with healthcare professionals, sales and marketing colleagues must adhere to the same promotional guidelines outlined above for pharmaceutical drug promotion when it comes to unapproved or non-cleared uses of Bausch + Lomb medical devices.
Promotion of Human Cells, Tissues, and Cellular Tissue-Based Products (HCT/P) to healthcare professionals and other customers must comply with the regulatory requirements for tissue products set by the agency, such as homologous use and minimal manipulation. Depending on their intended use, HCT/Ps may be regulated by the FDA as drugs, devices, and/or Biological Products (Biologics). Therefore, all promotion of HCT/P products must use only corporately approved materials and be carried out in accordance with Bausch + Lomb corporate guidelines.
Promotion of Human Cells, Tissues, and Cellular Tissue-Based Products (HCT/P) to healthcare professionals and other customers must comply with the regulatory requirements for tissue products set by the agency, such as homologous use and minimal manipulation. Depending on their intended use, HCT/Ps may be regulated by the FDA as drugs, devices, and/or Biological Products (Biologics). Therefore, all promotion of HCT/P products must use only corporately approved materials and be carried out in accordance with Bausch + Lomb corporate guidelines.
Approved accounts help ensure that sales calls are directed to appropriate audiences, consisting of healthcare professionals (or their support staff) and the healthcare institutions (HCIs) they serve. Sales colleagues are permitted to engage only with HCPs or HCIs that qualify as appropriate accounts and align with the approved product labeling, PMA, or 510(k) clearance. Promotional efforts during sales calls and events should not target HCPs who have little or no opportunity to use the product in accordance with the approved labeling, PMA, or 510(k).
Incentive Compensation (IC) plans for sales colleagues are designed to encourage activities aligned with the intended goals of the plan while discouraging improper promotion, sales, and marketing practices. These plans ensure that sales colleagues do not receive financial incentives for calling on HCPs or HCIs unlikely to use the product consistent with the approved product labeling, PMA, or 510(k).
Promotional activities aimed at U.S. HCPs must comply with FDA-approved labeling, PMA, or 510(k), even if these activities occur outside the United States. For instance, if Bausch + Lomb hosts a promotional conference abroad and invites U.S. HCPs, discussions must be limited to the uses approved in the U.S. Materials used at such events must also be approved through Bausch + Lomb’s promotional review process and, where applicable, by local regulatory personnel.
Approved accounts help ensure that sales calls are directed to appropriate audiences, consisting of healthcare professionals (or their support staff) and the healthcare institutions (HCIs) they serve. Sales colleagues are permitted to engage only with HCPs or HCIs that qualify as appropriate accounts and align with the approved product labeling, PMA, or 510(k) clearance. Promotional efforts during sales calls and events should not target HCPs who have little or no opportunity to use the product in accordance with the approved labeling, PMA, or 510(k).
Incentive Compensation (IC) plans for sales colleagues are designed to encourage activities aligned with the intended goals of the plan while discouraging improper promotion, sales, and marketing practices. These plans ensure that sales colleagues do not receive financial incentives for calling on HCPs or HCIs unlikely to use the product consistent with the approved product labeling, PMA, or 510(k).
Promotional activities aimed at U.S. HCPs must comply with FDA-approved labeling, PMA, or 510(k), even if these activities occur outside the United States. For instance, if Bausch + Lomb hosts a promotional conference abroad and invites U.S. HCPs, discussions must be limited to the uses approved in the U.S. Materials used at such events must also be approved through Bausch + Lomb’s promotional review process and, where applicable, by local regulatory personnel.
Bausch + Lomb colleagues are prohibited from making comparative claims unless these claims are included in approved product training or promotional materials.
Bausch + Lomb colleagues are prohibited from making comparative claims unless these claims are included in approved product training or promotional materials.
The primary method for field-based sales colleagues to communicate with healthcare professionals (HCPs) when promoting pharmaceutical products should be face-to-face. A current Package Insert (PI) and, where applicable, instructions for use may be provided for each pharmaceutical product discussed with an HCP. Both pharmaceutical and medical device products must be presented in accordance with their approved or cleared uses and the guidelines set forth in this Guide.
Electronic Communication
Colleagues may email HCPs to discuss promoted products or related disease states only through corporately approved systems, such as iRep trigger mail, or promotional HCP resources that have been approved through Bausch + Lomb’s promotional review process for email use by field personnel (use of personal email accounts is not allowed). Specific procedures must be followed to ensure safety information is presented in an appropriate format and layout when sharing these resources electronically.
In limited situations, emails or texts without product claims or messaging may be used solely for logistical purposes, such as scheduling meetings or providing directions to a program. Sales colleagues must use their Bausch + Lomb-provided email accounts for all communications related to Bausch + Lomb business. It is acceptable to attach a PI to an email in response to an HCP request as an alternative to scheduling an appointment. However, if an HCP asks product- or disease-related questions via email, sales colleagues should avoid responding directly and instead redirect the conversation to arrange a live meeting. The HCP can also be referred to the Medical Information department if necessary.
Non-Electronic Communication
Sales colleagues are not permitted to send hard-copy mailings or faxes to HCPs under any circumstances. The only acceptable method for sending product information via mail is through a Bausch + Lomb-managed mail program (e.g., trigger mail).
The primary method for field-based sales colleagues to communicate with healthcare professionals (HCPs) when promoting pharmaceutical products should be face-to-face. A current Package Insert (PI) and, where applicable, instructions for use may be provided for each pharmaceutical product discussed with an HCP. Both pharmaceutical and medical device products must be presented in accordance with their approved or cleared uses and the guidelines set forth in this Guide.
Electronic Communication
Colleagues may email HCPs to discuss promoted products or related disease states only through corporately approved systems, such as iRep trigger mail, or promotional HCP resources that have been approved through Bausch + Lomb’s promotional review process for email use by field personnel (use of personal email accounts is not allowed). Specific procedures must be followed to ensure safety information is presented in an appropriate format and layout when sharing these resources electronically.
In limited situations, emails or texts without product claims or messaging may be used solely for logistical purposes, such as scheduling meetings or providing directions to a program. Sales colleagues must use their Bausch + Lomb-provided email accounts for all communications related to Bausch + Lomb business. It is acceptable to attach a PI to an email in response to an HCP request as an alternative to scheduling an appointment. However, if an HCP asks product- or disease-related questions via email, sales colleagues should avoid responding directly and instead redirect the conversation to arrange a live meeting. The HCP can also be referred to the Medical Information department if necessary.
Non-Electronic Communication
Sales colleagues are not permitted to send hard-copy mailings or faxes to HCPs under any circumstances. The only acceptable method for sending product information via mail is through a Bausch + Lomb-managed mail program (e.g., trigger mail).
Before interacting with an international healthcare professional (HCP) or offering any items of value, the Compliance department must be consulted to ensure that Bausch + Lomb adheres to all applicable local regulations governing HCP interactions.
Before interacting with an international healthcare professional (HCP) or offering any items of value, the Compliance department must be consulted to ensure that Bausch + Lomb adheres to all applicable local regulations governing HCP interactions.
Patient Assistance Programs
If a physician requests patient assistance forms or similar materials, Bausch + Lomb colleagues may only direct the healthcare professional (HCP) to the relevant Patient Assistance Program (PAP) for their brand and business division. This enables the HCP to access patient assistance forms or related third-party information. Sales colleagues are limited to providing information on how to obtain these third-party materials or access the PAP; they must not complete or submit forms or information on behalf of the HCP. For example, in response to an Unsolicited request for PAP information, colleagues may refer the HCP to the plan’s PAP website but should not print, copy, or display forms to the physician or their staff. Additionally, if any form references Bausch + Lomb or competitor products, discussing such forms may be considered the use of unauthorized promotional materials, which is against Bausch + Lomb policy.
Managed Care Information and Prior Authorizations
Where applicable, field sales colleagues may share factual information regarding specific managed care plan requirements (e.g., formulary status or plan criteria) but must not provide guidance on completing prior authorization forms, what to write, or how to resubmit them for approval. If asked about obtaining prior authorization, sales colleagues may discuss general requirements, such as the need for a patient to try a generic product before qualifying for a branded agent but must not advise HCPs on how to complete the forms. Sales colleagues should not participate in completing or assisting with prior authorization forms. Approved formulary drug lists obtained directly from managed care plans, or third parties may be shown to physicians, provided these lists have not been altered (e.g., highlighted, underlined).
Any materials protected by third-party copyrights must never be distributed electronically or in hard copy to avoid copyright infringement. Additionally, distributing such materials may be considered unauthorized promotional activity and violate Bausch + Lomb policy.
Patient Assistance Programs
If a physician requests patient assistance forms or similar materials, Bausch + Lomb colleagues may only direct the healthcare professional (HCP) to the relevant Patient Assistance Program (PAP) for their brand and business division. This enables the HCP to access patient assistance forms or related third-party information. Sales colleagues are limited to providing information on how to obtain these third-party materials or access the PAP; they must not complete or submit forms or information on behalf of the HCP. For example, in response to an Unsolicited request for PAP information, colleagues may refer the HCP to the plan’s PAP website but should not print, copy, or display forms to the physician or their staff. Additionally, if any form references Bausch + Lomb or competitor products, discussing such forms may be considered the use of unauthorized promotional materials, which is against Bausch + Lomb policy.
Managed Care Information and Prior Authorizations
Where applicable, field sales colleagues may share factual information regarding specific managed care plan requirements (e.g., formulary status or plan criteria) but must not provide guidance on completing prior authorization forms, what to write, or how to resubmit them for approval. If asked about obtaining prior authorization, sales colleagues may discuss general requirements, such as the need for a patient to try a generic product before qualifying for a branded agent but must not advise HCPs on how to complete the forms. Sales colleagues should not participate in completing or assisting with prior authorization forms. Approved formulary drug lists obtained directly from managed care plans, or third parties may be shown to physicians, provided these lists have not been altered (e.g., highlighted, underlined).
Any materials protected by third-party copyrights must never be distributed electronically or in hard copy to avoid copyright infringement. Additionally, distributing such materials may be considered unauthorized promotional activity and violate Bausch + Lomb policy.
A Bausch + Lomb representative should never provide reimbursement information to an HCP based on what other HCPs might be submitting on their claim forms nor should a Bausch + Lomb Colleague suggest to an HCP how to complete paperwork to ensure reimbursement. Further, Bausch + Lomb may never provide information specific to a patient, an individual claim or a reimbursement decision.
Bausch + Lomb colleagues may be invited to participate (e.g., staff a booth, present to convention attendees, etc.) in regional or national commercial conventions where Bausch + Lomb is a sponsor or participant, such as staffing a booth or presenting to attendees.
In these situations, Bausch + Lomb will provide specific guidelines outlining acceptable activities in that particular setting. All promotional requirements that apply to other promotional activities also apply to convention participation, including the use of only approved materials and strict prohibition of Off-Label promotion. Within designated scientific areas—such as Medical Information kiosks or booths—it may be permissible to provide peer-reviewed scientific information beyond a product’s approved labeling in response to a request. However, this falls under FDA regulations on “scientific exchange” and is not considered promotional activity. Such exchanges are conducted by Medical Affairs, Clinical Development, or other non-sales colleagues.
Regional and national conventions should be held at locations where the primary purpose is to promote objective educational and scientific discourse, with the main goal of advancing attendees’ knowledge on the topics discussed. The convention organizers must retain full responsibility and control over content selection, faculty, educational methods, materials, and venue.
Financial support from Bausch + Lomb for convention activities should:
Bausch + Lomb colleagues may be invited to participate (e.g., staff a booth, present to convention attendees, etc.) in regional or national commercial conventions where Bausch + Lomb is a sponsor or participant, such as staffing a booth or presenting to attendees.
In these situations, Bausch + Lomb will provide specific guidelines outlining acceptable activities in that particular setting. All promotional requirements that apply to other promotional activities also apply to convention participation, including the use of only approved materials and strict prohibition of Off-Label promotion. Within designated scientific areas—such as Medical Information kiosks or booths—it may be permissible to provide peer-reviewed scientific information beyond a product’s approved labeling in response to a request. However, this falls under FDA regulations on “scientific exchange” and is not considered promotional activity. Such exchanges are conducted by Medical Affairs, Clinical Development, or other non-sales colleagues.
Regional and national conventions should be held at locations where the primary purpose is to promote objective educational and scientific discourse, with the main goal of advancing attendees’ knowledge on the topics discussed. The convention organizers must retain full responsibility and control over content selection, faculty, educational methods, materials, and venue.
Financial support from Bausch + Lomb for convention activities should:
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