Transparency Other Disclosures
California Compliance Program
A growing number of laws in the United States require greater transparency in the relationships between our industry and individuals and entities involved in providing health care. These laws impose various combinations of code of conduct restrictions on activities involving health care professionals and health care organizations and tracking and reporting of payments and transfers of value provided. Abbott complies with all such laws, which currently exist in California, the District of Columbia, Massachusetts, Minnesota, Nevada, Vermont, and West Virginia.
California HUMIRA Sharps Program
Abbott and the U.S.-EU & U.S.-Swiss Safe Harbor Privacy Statement
Abbott Laboratories complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information of employees of Abbott Laboratories and its affiliates and subsidiaries in European Economic Area/ European Union member countries and Switzerland. Abbott has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement with respect to this information.
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California Transparency in Supply Chains Act
Abbott believes in being a socially responsible company and doing what is right, not just by our customers, but by the world in which we live. Abbott is committed to safe and fair working conditions, beyond our employees and the stores in which our products are sold, but also extending to the partners in our supply chain. Abbott always has had and will continue to have a zero tolerance policy regarding human trafficking and slavery. Abbott has a global policy against trafficking and slavery in supply chains. Abbott engages in verification of product supply chains to evaluate and address risks of human trafficking and slavery. Specifically, Abbott utilizes a supplier classification model to determine appropriate activity level to assess risk. A supplier may receive a letter, a survey or an on-site audit (usually announced ahead of time) based on this model. Information received from the supplier is then assessed to determine whether to take further steps. Currently, this verification is conducted by Abbott employees in its Global Purchasing Services Compliance department.
Abbott’s Supplier Guidelines state our expectations to suppliers conducting business with Abbott that they are prohibited from engaging in illegal behavior, including human trafficking and slavery. Abbott’s internal Code of Business Conduct also incorporates standards prohibiting slavery/trafficking or engaging in illegal behavior. Abbott requires direct suppliers to certify that materials incorporated into Abbott’s products comply with local and national laws of the country or countries in which they are doing business. Certifications are also obtained from suppliers that they comply with standards as outlined in our Supplier Guidelines. Abbott maintains internal accountability standards and procedures for both employees and contractors failing to meet company standards regarding slavery and trafficking. In particular, Abbott employees worldwide train annually on Abbott’s Code of Business Conduct. Likewise, all contractors assigned to Abbott are required to review and abide by Abbott’s Code of Business Conduct.
Employees and contractors assigned to Abbott who fail to abide by Abbott’s Code of Business Conduct may be subject to reprimand or other adverse consequences, up to and including termination of employment or assignment. Abbott provides training to its employees and management who have direct responsibility for supply chain management, regarding human trafficking and slavery, particularly with respect to mitigating risks within the supply chains of products.
U.S. Postmarketing Commitments
Following approval of a drug or biologic product, the U.S. Food and Drug Administration (FDA) may request and/or require the sponsoring company to conduct further studies that are designed to gather additional information about a product’s safety, effectiveness, and/or optimal use. These postmarketing commitment (PMC) studies build upon the data that was submitted for approval.
This website contains Abbott’s U.S. postmarketing commitments. Click here to view Abbott’s PMC Summary Table.
Our PMC Summary Table includes all active postmarketing commitments and provides the following information, organized alphabetically by product name:
- Name of Product
- NDA/BLA Number
- Description of Commitment
- Date Commitment Given
- FDA Projected Completion Date
- Commitment Status
Please note that the status and/or number of Abbott’s postmarketing commitments shown on the FDA website may differ from the information displayed on this site based on the timing of content review and website updates. The status categories used in the PMC Summary Table are consistent with categories used by the FDA.
Information about Abbott’s PMCs will be updated twice a year, to reflect new commitments as well as the progress we have made in fulfilling our existing postmarketing commitments. Once the FDA determines a PMC is fulfilled, or they release Abbott from a commitment, or if Abbott terminates a study before completion date, those PMCs will be removed from our PMC Summary Table.
The PMCs listed in the PMC Summary Table include preclinical (nonhuman), clinical (medical), and epidemiological studies that Abbott has agreed to conduct to gather additional information about the safe and effective use of our approved products. This website does not contain technical chemistry, manufacturing and controls (CMC) PMCs, or PMCs issued by FDA for products where Abbott does not hold the US regulatory approval.
Note: All data reflects Abbott activities in 2012. Some content has been adjusted to remove data specific to AbbVie, which became a separate company on Jan. 1, 2013.