Ineligible Companies are those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Examples of such organizations include:
- •Advertising, marketing, or communication firms whose clients are ineligible companies
- •Bio-medical startups that have begun a governmental regulatory approval process
- •Compounding pharmacies that manufacture proprietary compounds
- •Device manufacturers or distributors
- •Diagnostic labs that sell proprietary products
- •Growers, distributors, manufacturers or sellers of medical foods and dietary supplements
- •Manufacturers of health-related wearable products
- •Pharmaceutical companies or distributors
- •Pharmacy benefit managers
- •Reagent manufacturers or sellers
ACCME focuses on financial relationships with ineligible companies during the 24 months prior to the activity. There is no minimum financial threshold; we ask that you disclose all financial relationships, regardless of the amount, with ineligible companies. You should disclose all financial relationships regardless of the potential relevance of each relationship to the education.
Examples of financial relationships include employee, researcher, consultant, advisor, speaker, independent contractor (including contracted research), royalties or patent beneficiary, executive role, and ownership interest. Individual stocks and stock options should be disclosed; diversified mutual funds do not need to be disclosed.
Research funding from ineligible companies should be disclosed by the principal or named investigator even if that individual’s institution receives the research grant and manages the funds.
Important note: A biomedical startup is ONLY considered an ineligible company if it has begun a governmental regulatory approval process. Please do not disclose start up companies if they do not fit the definition.
- •Drugs: The ACCME considers the submission of the Investigational New Drug Application (IND), which must be approved before clinical trials can begin, as the point of entry into the government regulatory approval process. This graphic published on the FDA website shows where in the drug development cycle the IND is submitted. Once a company makes this submission, it would be considered an ineligible company.
- •Medical devices: When a company initiates a premarket approval (PMA) process submission, as described on the FDA website here, it would then be considered an ineligible company.
Please visit the ACCME website for more details: https://accme.org/accreditation-rules/standards-for-integrity-independence-accredited-ce
