Compliance & Transparency
Our Commitment to Compliance
“At TG we have big ideas, take bold actions and are fearless in our pursuit to develop the best possible treatment solutions for those with B-cell diseases. As we work together to accomplish these goals, we hold one another to the highest standards both in what we do and how we do it.”
– Mike Weiss, Chief Executive Officer
At TG, everyone owns compliance. Our Compliance Program is based on the principles of the Office of Inspector General’s Seven Elements of an Effective Compliance Program. In addition, we voluntarily subscribe to the “Code on Interactions with Healthcare Professionals” published by The Pharmaceutical Research and Manufacturers of America (the “PhRMA Code”) and have adopted policies, procedures and processes to ensure compliance with the PhRMA Code. We have tailored our Compliance Program to meet the specific nature of our business and continuously assesses its effectiveness in order to meet our evolving compliance needs.
State Declarations and Disclosures
DECLARATION OF COMPLIANCE FOR CALIFORNIA
Click the documents below for a description of TG’s Comprehensive Compliance Program pursuant to the California Marketing Practices Act:
California Compliance Declaration (PDF)
COLORADO DISCLOSURE ACT
Colorado law HB 19-1131 requires pharmaceutical manufacturers to provide the wholesale acquisition cost (WAC) of the drug when engaging in prescription drug marketing to Colorado prescribers. Under Colorado law, the names of generic prescription drugs (if available) from the same therapeutic class (i.e., same or similar mechanism of action used to treat a specific condition) shall also be provided.
UKONIQTM (umbralisib) Colorado Disclosure Form (PDF)
VERMONT DISCLOSURE ACT
Vermont law 33 V.S.A. §2005a requires pharmaceutical manufacturers to disclose to Vermont physicians and other prescribers the average wholesale price (AWP) of drugs they market within the state as well as the prices of other drugs in the same therapeutic class. Under Vermont law, “therapeutic class” is defined as the therapeutic class listed in the 2004 American Hospital Formulary Service Pharmacologic-Therapeutic Classification published by the American Society of Health System Pharmacists (available at http://www.ashp.org).
UKONIQTM (umbralisib) Vermont Short Form Disclosure (PDF)
UKONIQTM (umbralisib) Vermont Long Form Disclosure (PDF)
The Physician Payment Sunshine Act (Sunshine Act) was passed as part of healthcare reform in March 2010 and was in effect as of August 1, 2013. The Sunshine Act, also referred to as “Open Payments,” requires pharmaceutical manufacturers such as TG to track and report certain ownership interests, payments, and transfers of value, including meals, refreshments, educational items, and fee-for-service compensation provided to certain types of licensed U.S. healthcare providers and teaching hospitals.
TG complies with these federal disclosure requirements and encourages you to reference the Open Payments website, which is managed by the Centers for Medicaid and Medicare Services (CMS), for additional information.
In addition to the federal requirements, TG is committed to complying with similar applicable state disclosure requirements
If you have any questions or inquiries related to data submitted by TG, please contact [email protected].
Authorized Distributor of Record
Thank you for doing your part to ensure the security of your pharmaceutical supply chain by only sourcing products from Authorized Distributors listed below.
TG Authorized Distributor of Record List