STATE OF CALIFORNIA COMPLIANCE PROGRAM DECLARATION
NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code, Section 119402 which requires pharmaceutical companies doing business in California to (1) adopt a Comprehensive Compliance Program that is in accordance with the U.S. Department of Health and Human Services, Office of Inspector General’s (“OIG”) “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”), and include policies for complying with the Pharmaceutical Research and Manufacturers of America Code (“PhRMA Code”), (2) make their Compliance Program publicly available, and (3) provide annual written declaration of their adherence to the requirements of the Compliance Program. Further, the law requires that the Comprehensive Compliance Program include an annual limit for certain items and activities given to healthcare professionals covered by this California law.
As described in our Healthcare Compliance Program Overview, Agios has established a Compliance Program in accordance with the United States Department of Health and Human Services Office of Inspector General’s (“OIG”) Compliance Program Guidance for Pharmaceutical Manufacturers”, and has policies in place to foster compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”) for their pharmaceutical businesses. We have tailored our Compliance Program to meet the specific needs of the Company and continue to assess its effectiveness.
In addition, in accordance with the requirements of California Health & Safety Code §§ 119400-119402, we have established an annual aggregate dollar limit of $1,500 for certain spending on individual medical or healthcare professionals licensed in California. We include in this dollar limit the value of educational items and meals provided to healthcare professionals in connection with business and educational discussions with those individuals. The annual spending limit set forth in this declaration does not include the value of:
- financial support for continuing medical education forums
- financial support for health education scholarships
- payments made for legitimate professional services provided by a healthcare professional so long as the amount paid does not exceed the fair market value of the services provided
- patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition
This dollar limit represents a spending cap and not an average or goal. The Company has established internal monitoring systems designed to help ensure compliance with the annual spending limits in California. We reserve the right to change this limit at any time.
We also adhere to global transparency laws and regulations, including Section 6002 of the Patient Protection and Affordable Care Act, which requires us to report payments and transfers of value made to certain healthcare professionals and teaching hospitals.
SEPTEMBER 1, 2023 CALIFORNIA DECLARATION OF COMPLIANCE
To the best of our knowledge and based on our good faith understanding of the statutory requirements, we declare that we are in compliance with our Compliance Program and the requirements of California Health & Safety Code §§ 119400-119402 in all material respects.
This declaration is not intended, nor should it be construed, to imply that we have not identified any individual instances in which an employee has or may have violated one or more provisions of our Compliance Program. In such situations, we take reasonable and appropriate remedial or corrective actions in a manner consistent with our Compliance Program.
For a written copy of the Compliance Program description or this Declaration, contact our Compliance Department at firstname.lastname@example.org or our corporate headquarters at (617) 649-8600.