FDA Disclosures and CMS Open Payments

Financial conflicts of interest must be considered, disclosed, and certified by researchers using Form 3454 and Form 3455 in conducting applicable FDA-covered clinical studies. This regulation requirement is established by 21 CFR § 54.4(a). Through these disclosures, the FDA can then assess possible bias. The type of financial interest or arrangement disclosed is important because some financial interests and arrangements are of greater concern than others when assessing the reliability of the data.

Forms 3454 and 3455 are integral to the financial disclosure process for applicable FDA-regulated research studies, particularly for investigational new drug (IND) and investigational device exemption (IDE) clinical studies.

• FDA Form 3454: This form is used by the sponsor to certify that no financial interests or arrangements exist that could affect the reliability of the data submitted. It is a certification of the absence of financial conflicts of interest among the clinical investigators.
• FDA Form 3455: This form is used when there are financial interests or arrangements to disclose. The sponsor must provide detailed information about these financial interests, including the nature and amount of the financial interest and how it might affect the study.

These forms are submitted by the study sponsor to the FDA as part of the marketing application process. Please see the outline of this process here:

Please note that FDA Forms must be maintained in a regulatory binder. Lurie Children’s teams maintain a copy of these forms locally. Additionally, post-approval monitoring teams monitor to verify that these documents are available.

The Open Payments database houses a national disclosure program administered by the Centers for Medicare & Medicaid Services (CMS) to promote transparency and accountability in the health care system. The database collects and publishes information from vendors and others about payments and transfers of value that are made to physicians and teaching hospitals. This may include general payments such as consulting services, research funding, as well as ownership and investment interests. Examples of errors that can occur include duplicate entries, missing data, inconsistencies in reporting, and misattribution of sponsored research to the lead investigator rather than the institution. Given that the accuracy of this public data varies, it is critical to:

• Check reported values: Regularly review the data reported in the CMS Open Payments database.
• Verify financial relationships: Confirm that all financial relationships are disclosed and managed in accordance with institutional policies and federal regulations.
• Note the review and dispute period: Disputes and changes may be submitted annually between April and May 15.

Disputes and Changes

Researchers can review and dispute data in the Open Payments system during the calendar year in which it is first published. April 1 through May 15 is the pre-publication review and dispute period, where you may review your data and dispute any inaccuracies before the data is published.

Register and Review Data

1. Register with CMS Identity Management System and Open Payments System.
2. Access the CMS Open Payments database to review the reported information.

Cross-Check Data

1. Use the Open Payments System “Review and Dispute” module.
2. Choose the physician name and program year. Click “Show Records” to view reported payments or transfers of value.

Report Discrepancies

Provide a reason for your dispute. Disputes will be updated as they progress (e.g., “Initiated”, “Acknowledged”, “Resolved, no change,” “Withdrawn”, etc.)

Reporting entities will have time to correct records before they become public if disputes were initiated between April 1 through May 15. The data correction period extends from May 15 to May 30. Additional information about Open Payments, as well as additional tools and resources, can be found on the CMS Open Payments website. 

The Physician Payments Sunshine Act

Part of the Affordable Care Act, the Physician Payments Sunshine Act aims to increase transparency around financial relationships between manufacturers of drugs and medical devices and healthcare providers. Disclosure of payments and other transfers for consulting services, research funding, as well as ownership and investments valued over $10 to healthcare providers are required to shed light on potential conflicts of interest and promote ethical practices. Information disclosed by vendors and sponsors is publicly accessible through the CMS Open Payments database.

If you have any questions regarding the database or how to protect yourself, please contact the Research Compliance Conflict of Interest team.