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Living our values every day

Our Culture of Ethics and Compliance

Takeda is a global, values-based, R&D-driven biopharmaceutical leader committed to discovering and delivering life-transforming treatments, and committed to patients, our people and the planet. We’re guided by our values of Takeda-ism, which incorporate Integrity, Fairness, Honesty and Perseverance, with Integrity at the core. They’re brought to life through actions based on Patient-Trust-Reputation-Business.

A culture of ethics and compliance is born out of this foundation and shapes the decisions we make and the actions that we take as Takeda employees. Please view the Takeda Global Code of Conduct for more information.

To report a suspected violation, please call 1-888-TAKEDA-0 (1-888-825-3320) or make an online report via EthicsPoint.

Pursuant to the Consumer Product Safety Improvement Act (CPSIA), manufacturers of imported or domestically manufactured (U.S.A.) prescription drug products that are subject to a consumer product safety rule, ban, standard or regulation enforced by the U.S. Consumer Product Safety Commission (CPSC) are required to provide General Certificates of Conformity (GCC).

 

Takeda manufactures prescription drug products that are governed under the CPSC regulations. The Takeda GCC certifies that the product (the child-resistant package) complies with the Poison Prevention Packaging Act (PPPA) requirements for special packaging under 16 CFR § 1700.

 

The GCCs are maintained to reflect additions of new products and existing product changes. Please see CPSC regulations for further information and see product-specific GCC listings below.

 

Name Dosage Type Prescribing Information
ACTOS (pioglitazone)

30ct bottle, 15mg tablet
30ct bottle, 30mg tablet
30ct bottle, 45mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
ACTOplus met (pioglitazone and metformin HCI)

60ct bottle, 15mg/500mg tablet
60ct bottle, 15mg/850mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide

ACTOplus met XR (pioglitazone and metformin HCI) (extended release)
(Discontinued)

30ct bottle, 15mg/1000mg tablet
30ct bottle, 30mg/1000mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
COLCRYS (colchicine)

30ct bottle, 0.6mg tablet
100ct bottle, 0.6mg tablet

Tablet Click here for Prescribing Information including medication guide
DEXILANT (dexlansoprazole)

5ct bottle, 30mg capsule
5ct bottle, 60mg capsule
30ct bottle, 30mg capsule
30ct bottle, 60mg capsule
90ct bottle, 60mg capsule

Capsule


Click here for Prescribing Information including medication guide

Duetact (pioglitazone and glimepiride)

30ct bottle, 30mg/2mg tablet
30ct bottle, 30mg/4mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
KAZANO (alogliptin and metformin HCI)

60ct bottle, 12.5mg/500mg tablet
60ct bottle, 12.5mg/1000mg tablet

Tablet

Click here for Prescribing Information including boxed warning and medication guide
NESINA (alogliptin)

30ct bottle, 12.5mg tablet
30ct bottle, 25mg tablet
30ct bottle, 6.25mg tablet

Tablet Click here for Prescribing Information including medication guide
OSENI (alogliptin and pioglitazone)

30ct bottle, 12.5mg/15mg tablet
30ct bottle, 12.5mg/30mg tablet
30ct bottle, 12.5mg/45mg tablet
30ct bottle, 25mg/15mg tablet
30ct bottle, 25mg/30mg tablet
30ct bottle, 25mg/45mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
PREVACID (lansoprazole)

30ct bottle, 15mg capsule
100ct bottle, 30mg capsule

Capsule Click here for Prescribing Information including medication guide
ROZEREM (ramelteon)

30ct bottle, 8mg tablet
100ct bottle, 8mg tablet

Tablet Click here for Prescribing Information including medication guide
TRINTELLIX (vortioxetine)

7ct bottle, 5mg tablet
7ct bottle, 10mg tablet
30ct bottle, 5mg tablet
30ct bottle, 10mg tablet
30ct bottle, 20mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
ULORIC (febuxostat)

7ct bottle, 40mg tablet
7ct bottle, 80mg tablet
30ct bottle, 40mg tablet
30ct bottle, 80mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide

 

ACTOS®, ACTOPLUS MET® and DUETACT® are registered trademarks of Takeda Pharmaceutical Company Limited.

 

COLCRYS® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc.

 

DEXILANT® and the DEXILANT Logo® are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc.

 

KAZANO® is a registered trademark of Takeda Pharmaceutical Company Limited.

 

NESINA® is a registered trademark of Takeda Pharmaceutical Company Limited.

 

OSENI® is a registered trademark of Takeda Pharmaceutical Company Limited.

 

PREVACID® is a registered trademark of Takeda Pharmaceuticals U. S. A., Inc.  

 

ROZEREM® is a registered trademark of Takeda Pharmaceutical Company Limited.

 

TRINTELLIX® is a registered trademark of H. Lundbeck A/S and used under license by Takeda Pharmaceuticals America, Inc.

 

ULORIC® is a registered trademark of Teijin Kabushiki Kaisha (Teijin Limited), used under license.


Ethical Participation in Federal Health Care Programs

Takeda is committed to being a lawful, compliant, and ethical participant in the federal health care programs. Many federal and state laws, regulations, and other legal requirements, including the federal False Claims Act, have been created to prevent and help detect fraud, waste, and abuse in federal health care programs.

 

Takeda complies with any such applicable requirements in full, and has developed various policies and procedures for detecting and preventing fraud, waste and abuse. Takeda maintains a Corporate Ethics & Compliance program, which includes a Code of Conduct, policies and procedures for detecting and preventing fraud, waste and abuse, a monitoring program and a Compliance Hotline/Helpline. Please contact Ethics & Compliance for more information at USBUCompliance@takeda.com.

 


Takeda is a global, values-based, R&D-driven biopharmaceutical leader with a large U.S. presence. We connect to our 240-year-old history and Japanese heritage through everything we do. Our unwavering commitment to putting patients first guides our scientific discovery and helps us as we strive to address unmet medical needs. As Takeda’s U.S. operations are integral to our global business, it’s important for Takeda to have appropriate engagement opportunities with U.S. policymakers and policy influencers.

 

The U.S. government accounts for nearly half of all U.S. health care spending, and its policies, legislation, and regulations impact the entire health care system. In order to ensure that Takeda’s point of view is considered by policymakers in critical debates affecting our products and therapeutic areas, we must provide a regular stream of information over time to educate elected officials on both sides of the aisle.

 

Lobbying Activities

Elected officials have an impact on public policy issues affecting Takeda and the patients we serve. We believe that public policy engagement is an important and appropriate role for companies when conducted in a legal and transparent manner. In the U.S., there are important federal and state lobbying registration and disclosure laws with which Takeda complies.

 

Where required, Takeda reports lobbying activity at state and federal levels. Takeda files quarterly lobbying reports that capture federal lobbying activity in the Congress and with any federal agencies. Takeda’s reports can be found by searching the Congressional lobby disclosure website.

 

Trade Associations

Takeda is a member of several industry and trade groups that represent both the pharmaceutical industry and the business community at large in an effort to bring about consensus on broad policy issues that can impact Takeda’s business objectives and ability to serve patients. Takeda’s participation as a member of these various industry and trade groups comes with the understanding that we may not always agree with the positions of the larger organization and/or other members, and that we are committed to voicing our concerns as appropriate through our colleagues who serve on the boards and committees of these groups. We disclose our current memberships in the U.S. where annual dues are more than $25,000.

 

Political Contributions

In the U.S., Takeda is committed to supporting candidates of any party using fair and objective criteria in the selection of candidates − including those who support public policies that contribute to the health needs of our patients, pharmaceutical innovation, and the interests of our company. This support comes from two different sources: Takeda’s Political Action Committee (TakPAC) and from corporate funds where legally allowed.

 

TakPAC is a separate, segregated fund registered with the Federal Election Commission and connected to Takeda Pharmaceuticals America, Inc. as a Lobbyist/Registrant PAC. The purpose of TakPAC is to provide monetary contributions and other support to candidates for federal, state, and local offices. Employee participation in TakPAC is completely voluntary, all contribution guidelines are only suggestions, and employees are free to contribute more or less than the guidelines or nothing at all. Takeda will neither favor nor disadvantage any employee by reason of the amount of his or her contribution or decision not to contribute. Employees may refuse to contribute without reprisal.

 

TakPAC activity reports are filed monthly with additional reporting requirements during an election year. TakPAC’s reports are available on the Federal Election Commission’s website, and a list of all PAC contributions is included in the TakPAC Annual Report:

 

In some states, corporations are allowed to give directly to candidates in accordance with state campaign finance law. Takeda chooses to make contributions in some of these states, and discloses these contributions annually:

 


Open Payments Act

Takeda is committed to improving health for people worldwide through innovation in medicine. We recognize the important contributions of valuable insight, expertise, and feedback that health care professionals ("HCPs") provide to us in support of this mission.

 

Section 6002 of the Patient Protection and Affordable Care Act, commonly known as the Open Payments Act or the Sunshine Act, requires pharmaceutical manufacturers, including Takeda, to track “transfers of value” provided to actively-licensed U.S. HCPs and Teaching Hospitals (collectively described as “Covered Recipients”) and to submit an annual report detailing such transactions to the Center for Medicare and Medicaid Services by March 31st each year for the prior calendar year.

 

Report Information

It is helpful to understand that there are two reporting submission templates provided by the Centers for Medicare and Medicaid Services (CMS) for reporting transfers of value under the Open Payments Act: General Payments and Research Payments. Takeda will report transfers of value in these areas based on the type of interaction conducted with Covered Recipients and the statutory definitions. Transfers of value to Covered Recipients that do not meet the Open Payments Act definition of Research will be submitted on the General Payments template with a corresponding payment nature per the statutory requirements.

 

For 2021 spend, Takeda is required to report transfers of value to Covered Recipients provided by, or on behalf of, Takeda, including fees/reimbursable expenses that are individually greater than $11.05 or cumulatively greater than $110.40.

 

It is important to note that Research payments will appear as aligned both with the entity receiving the payment and the principal investigator(s) for the clinical trial.

 

Some additional examples of reportable transfers of value are listed below:

  • Professional Services: Including payments for advisory boards, consulting services, or promotional speaking
  • Educational Materials: Including certain reference materials such as journal articles and textbooks
  • Business Meals: Including Takeda-provided or reimbursed meals in conjunction with professional services or recruiting
  • Business Travel: Including Takeda provided or reimbursed amounts for transportation (e.g., airfare, hotel, taxi)

 

Collaboration

Takeda values working with Covered Recipients and we believe such collaboration is critical to deliver better health and a brighter future to patients we serve.

 

Additional Information about Open Payments

To learn more about the Open Payments Act, please visit the CMS website.

 

Questions

If you have any questions concerning this matter, please do not hesitate to contact us at SunshineActQuestions@takeda.com.

State Compliance

Compliance with state law requirements is an important feature of Takeda’s Ethics & Compliance Program. Click the links below for information relating to our state compliance efforts.

 

You can also view our California Annual Comprehensive Compliance Program Declaration by clicking the button below.

ADDERALL XR®
Short Form | Long Form

AGRYLIN®
Short Form | Long Form

ALUNBRIG®
Short Form | Long Form

AMITIZA®
Short Form | Long Form

COLCRYS®
Short Form | Long Form

CARBATROL®
Short Form | Long Form

DEXILANT®
Short Form | Long Form

EXKIVITY™
Short Form | Long Form

FOSRENOL®
Short Form | Long Form

ICLUSIG®
Short Form | Long Form

INTUNIV®
Short Form | Long Form

Kazano
Short Form | Long Form

LIALDA®
Short Form | Long Form

MOTEGRITY®
Short Form | Long Form

Mydayis®
Short Form | Long Form

NESINA®
Short Form | Long Form

NINLARO®
Short Form | Long Form

Oseni®
Short Form | Long Form

PENTASA®
Short Form | Long Form

ROZEREM®
Short Form | Long Form

TRINTELLIX®
Short Form | Long Form

ULORIC®
Short Form | Long Form

VYVANSE®
Short Form | Long Form