Fidia Pharma USA Inc.’s Corporate Compliance Program
Fidia Pharma USA Inc. (Fidia) has implemented a Comprehensive Compliance Program intended to comply with applicable federal, state, and local laws and regulations including the California Health and Safety Code §119400-119402 (CHSC). Fidia has adopted the voluntary HHS Office of Inspector’s guidance entitled “OIG Compliance Program Guidance for Pharmaceutical Manufacturers published in 2003.
Annual CHSC Spending Limit
CHSC requires prescription medical device companies to establish a specific annual dollar limit in their Comprehensive Compliance Program on gifts or incentives to healthcare professionals (HCPs). Fidia has established an annual spending limit of $2,000.00 for gifts, promotional materials or items and activities provided to HCPs who reside or practice in California. The following California HCPs are subject to this annual limit: 1) a person licensed by California State Law to prescribe medical devices for human use, 2) medical students, and 3) members of a drug formulary committee. The annual spend limit does not include the following expenses which are exempt for inclusion in the annual spend limit: 1) Professional samples intended for patient use, 2) Financial support for continuing medical education forums, 3) Financial support for health education scholarships, and 4) Payments and expenses associated with legitimate professional services that meet specific requirements outlined in Fidia’s Corporate Compliance Program.
CHSC Annual Compliance Declaration
CHSC requires prescription medical device companies to post on their websites an annual written declaration of compliance to the CHSC Comprehensive Compliance Program. To the best of its ability in understanding the requirements of the CHSC, Fidia declares compliance with its Comprehensive Compliance Program and the requirements of the California Health and Safety Code including its annual spending limit. A copy of our Compliance Declaration may be obtained by downloading this page or by emailing compliance@fidiapharma.us or calling our Compliance department as listed on our Contacts page on this website.