Principles on Responsible Sharing of Truthful and Non-Misleading Information About Medicines With Health Care Professionals and Payers
In the era of data-driven medicine, where all parties seek more, not less, information about the safety, effectiveness, and value of treatments, fostering informed communications among all stakeholders is critical. Today, the wealth of information about medicines is more comprehensive and complex than ever before. Scientific knowledge and new findings go far beyond data sets produced from clinical trials, often are outside the scope of the parameters established by Food and Drug Administration (FDA) regulations, and often outdate the FDAapproved labeling. In addition to information in the approved labeling for medicines, biopharmaceutical companies continually generate and collect important data and analyses that can benefit patient care and enhance the efficiency of our health care system.
To exercise sound medical judgment in treating patients, health care professionals must understand the full range of treatment options, including both established and emerging information about available medications. Biopharmaceutical companies are uniquely positioned to help health care professionals achieve the best outcomes for patients, because companies can provide timely, accurate, and comprehensive information about both approved and unapproved uses of the medications they research, develop, and bring to patients. PhRMA, BIO and their members believe that the availability of a wider range of truthful and non-misleading information can help health care professionals and payers make better informed medical decisions for their patients, which in turn will benefit patients.
In order to support the best use of scientific information for patient care, PhRMA and BIO endorse these Principles on Responsible Sharing of Truthful and Non-Misleading Information About Medicines with Health Care Professionals and Payers. These Principles are intended to form the basis for defining new and clear regulatory standards governing responsible, truthful and non-misleading communications to inform health care professionals about the safe and effective use of medicines. The Principles pertain primarily to data and information outside of FDAapproved labeling, and are intended to establish responsible, science-based parameters for accurate and trusted information sharing...
Points to Consider: Truthful and Non-Misleading Product Communication
For the last year, BIO’s Board Standing Committee on Bioethics (the “Bioethics Committee”) has studied the issue of biopharmaceutical companies’ truthful and nonmisleading communications about their products with healthcare professionals and payers from a bioethical perspective. This work has included engagement with: external experts representing the legal and regulatory perspective on the existing Food and Drug Administration (FDA) regime; representatives of the provider and patient communities; and experts in bioethics. In the past, BIO has primarily focused our advocacy with regard to the issue of truthful and non-misleading product communication around what aspects of FDA’s existing regulatory regime need to change, how those changes should be implemented, and to align the regime with First Amendment principles. However, to ensure that our advocacy is informed by a thoughtful, comprehensive perspective on the issue, the Bioethics Committee’s study sought to identify the bioethical underpinnings of why change is needed in the first place and how such considerations should influence the overall framework governing such communications.
Thus, this document identifies four Considerations that should provide the ethical foundation for any regime governing product communication. Each of these Considerations has been derived from the application of relevant aspects of BIO’s Statement of Ethical Principles. 1 Moving forward, as BIO participates in broader stakeholder discussions on this issue, BIO should ensure that our future advocacy around any changes to the legal and regulatory regime governing biopharmaceutical companies’ product communication is aligned with these four bioethical Considerations emanating from the Principles.
BIO’s existing advocacy on the issue of improving the information available to payers, providers, and patients is predicated on the bioethical norm that reliable, accurate, and meaningful healthcare information should be available in a timely manner: (1) to providers and, through them, patients, at the point of clinical decision-making; and (2) to payers at the point of coverage and reimbursement determinations. Robust scientific and medical dialogue serves the widely supported healthcare Triple Aim: improving the patient experience of care (including quality and satisfaction); improving the health of populations; and achieving a reasonable cost of health care without compromising quality, outcomes, or access.2
The need for stakeholders to be able to access truthful and non-misleading product information is even more pressing due to the overabundance of “alternative” sources of information (e.g., social media and the general availability of health-related information on the Internet, including information specific to products that may be prescribed for seriously ill patients). Often, these sources have not been validated but are nonetheless readily available to patients. The recognition that many stakeholders rely on these sources makes it ethically important that the information be analyzed appropriately to ensure it is valid and a true representation of the medical products it discusses and that valid, truthful, and nonmisleading information be communicated. In this way, stakeholders will have ready access to accurate, reliable, and meaningful information. This need will only be heightened by the drive to make medicine more personalized, which will demand more, not less, information, and especially information tailored to individual clinical circumstances...