GSK Focus on Healthy Communities for a Healthy America
America’s healthcare system is entering an era in which medicines, treatments and technologies are becoming far more advanced and personalized. To realize the broadest benefits from the coming medical revolution, GSK advocates for smart public policies structured around three pillars: collaboration within health care systems and communities, access to prevention services and quality health care for all, and innovation driving new and better treatments that meet patients’ needs.
- Healthy Communities for a Healthy America – Collaboration (PDF)
- Healthy Communities for a Healthy America – Access (PDF)
- Healthy Communities for a Healthy America – Innovation (PDF)
- Comprehensive Medication Management position paper (PDF)
- HIT Position Paper (PDF)
- Quality Policy Brief (PDF)
- Value Based Delivery Overview (PDF)
- Low-Income Subsidy (LIS) co-pay position paper (PDF)
- Communicating Comparative Effectiveness Research and Real World Evidence with Population Health Decision Makers position paper (PDF)
- Patent Litigation Reform position paper (PDF)
- Commitment to Biosecurity GSK Position Overview (PDF)
- Collaboration – Interagency Coordination and PP Partnerships position paper (PDF)
- Predictability – MCM Contract Incentives position paper (PDF)
- Predictability – MCM Regulatory Pathways position paper (PDF)
- Sustainability – Congressional Appropriations (PDF)
GSK and working with the healthcare and nonprofit communities
No researcher—or healthcare company—works in a silo. We need each other, and many others, to help move healthcare forward.
For our part, we work with members of the medical and research communities who are close to patients and understand both diseases and treatments. This sharing of information is vital to our mission to help people do more, feel better and live longer.
Working with members of the healthcare community—treating physicians, clinical researchers, patients, and professional associations and advocacy groups, etc.—may involve compensation for work performed, reimbursement for travel expenses, a charitable donation, or a grant.
Learn more about our work with the healthcare and nonprofit communities.
GSK and the environment
GSK has demonstrated a strong commitment to the safe and proper use and disposal of our self-injectable medications. Patient safety and needle stick injury prevention are given serious consideration in product development. In fact, inherent in the design of our injectable products, we use safe needle technology to shield the sharps and provide, at a minimum, approved sharps containers for home generated sharps waste materials.
- GlaxoSmithKline Safe Needle Disposal Plan - California (PDF)
- GlaxoSmithKline Safe Needle Disposal Plan - Minnesota (PDF)
GSK and post-marketing research
We don’t stop researching a medicine once it is approved by regulatory authorities. “Post-marketing” research may generate important new safety and efficacy information. We want to openly share information about the status of post-marketing research that we are obligated to conduct either to fulfill legal or regulatory requirements (post-marketing requirements or PMRs) or to carry out agreements with the US Food and Drug Administration (post-marketing commitments or PMCs).
Manufacturers of medicines are required to report to the FDA annually on the status of PMRs and PMCs and FDA is required to make certain information available to the public. Additional background on PMRs and PMCs is available on the FDA’s web site.
We will post information on our own website about PMRs and PMCs for U.S. marketed drugs and vaccines on a quarterly basis. Our quarterly updates will tend to reflect new developments more quickly than FDA’s website, which is based on required submissions of information from manufacturers that take place annually rather than quarterly.
Information will include the nature and status of the PMRs and PMCs. Like the FDA website, the GSK site will not include commitments with proprietary information (such as those to evaluate chemistry or manufacturing and control issues).
When a GSK-sponsored interventional clinical research study is completed, we are committed to seeking publication of the results in a peer-reviewed journal. Whether or not it actually gets published, we make available a summary of the results on our website in the GSK Clinical Study Register. The Register provides an easily accessible repository of summary results from across the range of GSK-sponsored clinical studies, including not only all GSK-sponsored interventional clinical trials but also certain GSK-sponsored non-interventional studies (observational studies, health outcomes studies, epidemiology studies, and meta-analyses and pooled analyses).
GSK and post-marketing requirements and commitments
Below are the column headings and explanation of terms found in the attached pdf file of GlaxoSmithKline PMRs and PMCs. 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 GSK has agreed to a final submission relating to the PMR or PMC.|
|Status (Pending, Ongoing, Delayed, Terminated, Submitted, Fulfilled and Released)||The status of the PMR or PMC at the last quarterly update (see definitions below)|
|Explanation of Status||An explanation is provided if the PMR or PMC is Delayed.|
|PMR or PMC Description||The description of the PMR or PMC|
The following define the status used for each PMR or PMC. Definitions are consistent with those of the FDA.
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.
- GSK post-marketing commitments report - October 2016 (PDF)
- GSK post-marketing commitments report - July 2016 (PDF)
- GSK post-marketing commitments report - April 2016 (PDF)
- GSK post-marketing commitments report - January 2016 (PDF)
- GSK post-marketing commitments report - October 2015 (PDF)
- GSK post-marketing commitments report - July 2015 (PDF)
- GSK post-marketing commitments report - April 2015 (PDF)
- GSK post-marketing commitments report - January 2015 (PDF)
- GSK post-marketing commitments report - October 2014 (PDF)
- GSK post-marketing commitments report - July 2014 (PDF)
- GSK post-marketing commitments report - April 2014 (PDF)
- GSK post-marketing commitments report - January 2014 (PDF)
- GSK post-marketing commitments report - October 2013 (PDF)
- GSK post-marketing commitments report - July 2013 (PDF)
- GSK post-marketing commitments report - April 2013 (PDF)
- GSK post-marketing commitments report - January 2013 (PDF)
- GSK post-marketing commitments report - October 2012 (PDF)
GSK and supply chain and human rights
Patients and consumers rely on us to provide an uninterrupted supply of medicines and products, manufactured to the highest-quality standards.
An effective and responsibly managed supply and distribution system is essential for us to get high-quality products to the right places at the right time. If we don’t do this, people’s health may suffer and their lives may even be at risk. To protect the interests of our patients and consumers, we aim to work with responsible suppliers who meet the same quality, social and environmental standards as GSK.
We are committed to upholding the UN Universal Declaration of Human Rights, the OECD Guidelines for Multinational Enterprises and the core labor standards set out by the International Labour Organization (ILO). We are also a signatory to the UN Global Compact, a voluntary global standard on human rights, labor, the environment and anti-corruption.
We believe governments have a responsibility to define and enforce a legal framework for human rights in accordance with international laws and agreements. Businesses also have responsibilities. We have direct control over human rights in our own operations and aim to act responsibly across all our spheres of influence which includes our employees, suppliers, local communities and society more broadly.
Read our human rights statement (PDF).
California Transparency in Supply Chains Act
We believe that our policies and processes to ensure respect for human rights align with the requirements of the US California Transparency in Supply Chains Act, which came into effect at the beginning of 2012.
Zebulon, NC Contractor Safety Manual
At GSK, we place a great emphasis on safety in the workplace. The Zebulon Contractor Safety Manual (PDF) contains policies and procedures applicable to all contractors and contract employees regarding environment health & safety responsibilities on GlaxoSmithKline Zebulon premises and for work performed for GSK Zebulon.
LGBT Rights in the United States
GSK supports the advancement of human and civil rights for the Lesbian, Gay, Bisexual, and Transgender (LGBT) community, in furtherance of the values of equality and inclusion that GSK espouses for all of its employees.
Read our LGBT rights statement (PDF).