We will do this by proactively providing nonproprietary information to stakeholders about Merck's business, how we operate, and decisions we take, which will help stakeholders make informed decisions about their interactions with the company and its products.
We will disclose information through a variety of mechanisms, including our financial disclosures, corporate responsibility reporting, participation in voluntary efforts such as the Carbon Disclosure Project, through the media, and through one-on-one stakeholder discussions. As part of our commitment to increase transparency, we also disclose information on our website about our business in the following areas:
Merck 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 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. Learn more.
As an early supporter of the Physician Payments Sunshine Act, we believe in broad disclosure of financial relationships between physicians and the pharmaceutical industry. In 2009, we began voluntarily disclosing all payments to U.S.-based healthcare professionals who speak on behalf of Merck or our products. Starting in June 2012, reports will include payments and transfers of value to U.S.-licensed physicians including those who consult and/or perform research on behalf of Merck. Learn more.
Starting in March 2009, Merck began reporting all philanthropic grants made through the Office of Corporate Philanthropy and The Merck Company Foundation. Learn more.
Merck is committed to participating constructively and responsibly in the political process. To improve access to information about Merck's advocacy activities, Merck discloses its 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 makes corporate political contributions, primarily to the electoral campaigns of individual candidates.
To improve access to information about Merck's corporate and political action committee contributions in the United States, Merck semiannually posts the company's contributions categorized by state, candidate and amount. Merck also discloses any contributions to committees known as 527 organizations or organizations organized under the 501c(4) section of the U.S. tax code. Merck posts its contributions in Canada and Australia annually.
Since 2008, we have also been disclosing the portion of dues that major U.S.-based trade associations report to us as being used for advocacy and/or political activities where dues are >$25,000. We encourage all trade associations to which we belong to publicly disclose their political activities as well. Learn more.
Merck recognizes 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, Merck 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 Web Site. Learn more.
Below are the column headings and explanation of terms found in the attached pdf file of Merck PMRs. The pdf file below is searchable.
|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 when Merck has agreed to a final submission relating to the post-marketing requirement to 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 if the requirement is Delayed or Terminated.|
|PMR Description||The description of the post-marketing requirement|
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 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 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, FDA is satisfied that the applicant has met the terms of the commitment.
Released: 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.
Since 2007, we have registered at trial initiation all clinical trials in patients in which treatment is assigned that the company sponsors and conducts worldwide on ClinicalTrials.gov. We also disclose results from registered clinical trials of marketed productsregardless of outcomeson www.ClinicalTrials.gov. Learn more.
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, Merck will voluntarily include the protocol and statistical analysis plan. Merck 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. Read the full press release.
The Carbon Disclosure Project (CDP) is an independent not-for-profit organization working to drive greenhouse gas emissions (GHG) reduction and sustainable water use by business 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. Merck has been disclosing climate information via the CDP for a number of years and more recently has participated in both their Water and Supply Chain disclosures.
We consider diversity and inclusion integral parts of the culture we seek to build. 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. Learn more.