Access to comprehensive information about a medication can keep physicians informed and yield better health care decisions, argues a new set of principles from the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America. And having better-informed physicians could be good news for patients.
For years, however, federal restrictions have limited communications between manufacturers and physicians. Now the new principles document suggests reconfiguring federal rules to allow physicians fuller access to clinical trials data, real-world evidence and scientific analyses.
The FDA-approved prescribing information, or label, should remain the primary vehicle for sharing information about a medication with physicians. Yet scientific information that postdates or complements the FDA label may also be helpful, the principles document explains. Such information may include:
- Data from randomized, controlled clinical trials
- Analyses of trials data such as sub-population information
- Real-world evidence such as data from patient registries and claims records
- Pharmacoeconomic information such as budget models and cost-effectiveness data.
These data sources could improve clinicians’ understanding of existing treatments. If shared prior to FDA approval of a new medicine, the document argues, they could also educate physicians about a forthcoming treatment, allowing patients quicker access once the therapy is available.
Reprint Practices and Off-label Uses
The principles document also suggests rethinking restrictions on specific forms of communication. The document suggests expanding the FDA’s “Good Reprint Practices” so that manufacturers can share medical journal articles on research they have sponsored – in addition to research sponsored by outside sources.
The authors also encourage open communication about off-label use of medical treatments. About 21 percent of prescriptions are for alternative, or “off-label,” uses of a drug. And national medical associations and compendia services often recommend or describe uses outside of FDA labeling. Information from biopharmaceutical companies, which often maintain the most complete and current clinical data about their medicines, could help round out physicians’ understanding of off-label uses.
Expanded communications must, however, adhere to certain requirements. The document emphasizes the need for communication to be accurate, non-misleading and science based. In conveying data to physicians, the authors explain, manufacturers must provide context and accurately show the limitations of the data. They should also tailor their communications to the clinicians’ level of knowledge.
To learn more and read scenarios of how these principles might apply to real-world situations, see “Principles on Responsible Sharing of Truthful and Non-misleading Information About Medicines with Health Care Professionals and Payers.”