Our company aspires to be open and transparent about how we operate in order to earn and retain the trust and confidence of our customers, employees, shareholders and other important stakeholders.
We do this by proactively providing nonproprietary information to stakeholders about our business and how we operate, which will help stakeholders make informed decisions about their interactions with the company and our products.
We disclose information through a variety of mechanisms, including our financial disclosures, the publication of our annual corporate responsibility report, and participation in voluntary efforts such as the CDP (formerly the Carbon Disclosure Project), through the media and through one-on-one stakeholder discussions. As part of this commitment to increasing transparency, we also disclose information in this corporate responsibility report in the following areas:
Our company is committed to the timely registration of clinical trial information and the disclosure of clinical trials—regardless of their outcomes.
Learn More about clinical trials.Clinical Trials Disclosures
Since 2007, we have registered at trial initiation all clinical trials in patients in which treatment is assigned that our company sponsors and conducts worldwide on www.ClinicalTrials.gov. We also disclose results from registered clinical trials of marketed products—regardless of outcomes.Clinical Trial Results
The clinical study results of our company and Schering-Plough, previously posted on the Pharmaceutical Research and Manufacturers of America (PhRMA) Clinical Study Results Database, have been available as of December 2011 on our corporate headquarters website.
We are committed to the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing.
Learn more about our policies and perspectives:
- Procedure on Access to Clinical Trial Data
- Procedure on CSR Synopsis Posting
- External Scientific Review Board (ESRB) Charter
Scientific and medical researchers who wish to submit a proposal for access to our company’s data may send an inquiry by clicking here.Clinical Research Protocols
Effective July 1, 2011, when we submit a manuscript on a study of an investigational or an approved medicine or vaccine to a biomedical journal, we will voluntarily include the protocol and statistical analysis plan. We previously supplied this material only upon request. Upon a journal’s acceptance of the manuscript for publication, we will provide the journal, at its own discretion, with the opportunity to post on its website the key sections of the protocol, including the objectives and hypotheses, patient inclusion and exclusion criteria, study design and procedures, efficacy and safety measures, the statistical analysis plan, and any amendments relating to those sections.
CDP is an independent not-for-profit organization working to drive greenhouse gas (GHG) emissions reduction and sustainable water use by businesses and cities.
CDP works with investors globally to advance the investment opportunities and reduce the risks posed by climate change by asking almost 6,000 of the world’s largest companies to report on their climate strategies, GHG emissions and energy use in the standardized Investor CDP format. We have been disclosing climate information via the CDP for a number of years and more recently have participated in both its Water and Supply Chain disclosures.
We were one of the first companies in the United States to annually disclose our Equal Employment Opportunity data and continue to do so annually.
We consider diversity and inclusion integral parts of the culture we seek to build. Learn more.
Grants to Medical, Scientific and Patient Organizations
Our company has a leadership role as a global corporate citizen in our respective industries. We believe that providing support through grants or donations to third-party medical, scientific and patient organizations is an important way to advance our mutual objectives to improve health and advance patient care.
We have robust standards and policies in place to ensure that our grants are intended for and provided in support of improving patient care, and are not promotional or likely to be perceived as being promotional in nature, or provided to induce or reward prescription of our products. Further, any grant or donation must also be permitted by and aligned with local country laws and regulations.
To learn more about our disclosure of grants inside the United States, click here.
To learn more about our disclosure of grants outside the United States, click here.
Payments to U.S.-Based Health Care Professionals
As an early supporter of the Physician Payments Sunshine Act (PPSA), we believe in broad disclosure of financial relationships between physicians and the pharmaceutical industry.
In October 2009, our company began voluntarily disclosing all payments to U.S.-based health care professionals who speak on behalf of our company, about our products and other health care issues.
In April 2012, we expanded our payments report to include post-merger speaking activities related to legacy Schering Plough, our company's medical forums and Inspire Pharmaceutical products. Learn more.
Payments to European-Based Health Care Professionals
We will begin disclosing payments to European-based health care professionals and health care organizations in 2016.
We will begin disclosing payments to European-based health care professionals and health care organizations in 2016 in alignment with the disclosure code announced by The European Federation of Pharmaceutical Industries and Associations (EFPIA) in July 2013. Our company played a supportive role in the development and adoption of the code by the EFPIA board.
Philanthropic Grants and Contributions
We report philanthropic grants and charitable contributions, including contributions made through the Office of Corporate Responsibility, our company's Foundation, U.S. Global Human Health and the MSD for Mothers Program. (*Reports were updated July 2016)
Corporate Political Advocacy and Contributions
Our company is committed to participating constructively and responsibly in the political process. To improve access to information about our advocacy activities, we disclose our costs associated with lobbying in the European Union and the United States.
Where permitted by law in the United States, Canada and Australia, the company provides corporate political contributions, primarily to the electoral campaigns of individual candidates.
To improve access to information about our corporate political and PAC contributions in the United States, our company semiannually posts our contributions, categorized by state, candidate and amount. We post our contributions in Canada and Australia annually.
We also disclose a list of industry and trade groups of which we are members and our dues (dues that are greater than $25,000) to U.S. trade associations that are used for political purposes. We encourage all trade associations to which we belong to publicly disclose their political activities as well. Learn more.
We recognize the importance of providing transparent information about the status of our marketing and development activities after a product has been approved by regulatory authorities. This information can help ensure health care providers and patients remain informed about our products.
To inform the public about post-marketing activities, we will, on a quarterly basis, post information concerning post-marketing requirements (PMRs) for U.S.-marketed products intended for human use on this website. Information will include the nature and status of the PMRs for the life cycle of a marketed product, in accordance with U.S. regulations. Information will include reference to clinical, non-clinical or pharmacovigilance studies/trials that have been identified as PMRs. Additional background on post-marketing requirements is available at the FDA website. Below are the column headings and explanations of terms found in the PDF files below of our company’s PMRs. The PDF files are searchable.
2017 U.S. Post-Marketing Requirements
2016 U.S. Post-Marketing Requirements
2015 U.S. Post-Marketing Requirements
2013 U.S. Post-Marketing Requirements
2012 U.S. Post-Marketing Requirements
The following define the status used for each requirement. These definitions are consistent with those of the U.S. FDA. There may be differences in the status of the information posted to this website and that on the FDA Post-Marketing Commitments website due primarily to the differences in timing of the updates.
Pending: The study has not been initiated (i.e., no subjects have been enrolled or animals dosed) but does not meet the criterion for delayed (i.e., the original projected date for initiation of patient accrual or initiation of animal dosing has not passed).
Ongoing: The study is proceeding according to, or is ahead of, the original schedule. The FDA considers a study to be ongoing until a final study report is submitted to the FDA, as long as the activities are proceeding according to the original study schedule. If patient accrual or animal dosing has started but is not complete, and the projected date for completion of that milestone has passed, the study should be categorized as delayed.
Delayed: The progression of the study is behind the original study schedule. Delays can occur in any phase of the study, including patient enrollment, analysis of study results, or submission of the final study report to the FDA. While the original study schedule—not a revised schedule—serves as the basis for defining a study as delayed, each phase of the study will be considered in its own right. If the applicant has one delayed phase, but gets back on schedule during the next phase, the delayed status will no longer apply.
Terminated: The applicant ended the study before completion and has not yet submitted a final study report to the FDA.
Submitted: The applicant has concluded or terminated the study and has submitted a final study report to the FDA, but the FDA has not yet notified the applicant in writing that the study commitment has been fulfilled or that the commitment has been released.
Fulfilled: The applicant has submitted the final study report for the commitment, and upon review of the final study report, the FDA is satisfied that the applicant has met the terms of the commitment.
Released: The FDA has informed the applicant that it has been released from its obligation to conduct the post-marketing study because the study is either no longer feasible or would no longer provide useful information.
|Product Name [TRADE NAME (generic name)]||Trade name used in the U.S. market (active ingredient[s] in the drug)|
|Due Date||The date by which our company has agreed to a final submission relating to the post-marketing requirement to the FDA|
|Status (Pending, Ongoing, Delayed, Terminated, Submitted, Fulfilled and Released)||The status of the requirement at the last quarterly update (see definitions below)|
|Explanation of Status||An explanation is provided where appropriate.|