On Wednesday, July 27, 2016, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) released guidelines for drug makers’ communications with other health care professionals about their products.
The guidelines encompassed nine principles aimed at improving relationships between biopharmaceutical companies and other players in the health care industry, calling on the Food and Drug Administration (FDA) to clarify what information biopharmaceutical companies can share in addition to approved labels. The principles focused on three main areas, commitment to: science-based communications, providing appropriate context about data, and accurately representing data.
According to the guidelines,
“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.”
The principles are as follows:
- Commitment to Accurate, Science-Based Communications
- FDA-Approved Labeling is a Primary Source in Sharing Information with Health Care Professionals About Medicines
- Companies Should Provide Scientific Substantiation if Shared Information is Not Contained in FDA-Approved Labeling
- Additional Science-based Information from Sources Other Than FDA-Approved Labeling Helps Health Care Professionals and Payers Make Informed Decisions for Patients
- Communications Should Be Tailored to the Sophistication of the Intended Audience
- Science-based Information About Alternative Uses of Medicines Can Improve Health Care Decision-Making
- Communicating with Payers About New Medicines and New Uses of Approved Medicines Facilitates Patient Access Upon Approval
- Real-World Evidence Based on Patient Experience and Pharmacoeconomic Information Can Improve Understanding of Health Outcomes and Costs
- Commitment to Share Information Published in Scientific or Medical Journals
The principles report from PhRMA and BIO goes on to illuminate how the responsible sharing of information, including the following categories, can improve patient care and the efficiency of the health care system:
- Data from randomized, controlled clinical trials that evaluate pre-specified endpoints under a clearly defined analysis plan.
- Post hoc analyses, including sub-population data. Randomized controlled clinical trials and observational studies often collect information on the safety and effectiveness of medicines in subpopulations, including specific gender and ethnic cohorts. If the trial has met its primary endpoint, subpopulation information may help health care professionals develop treatment strategies based on more precise safety and efficacy data for a particular cohort of patients.
- Observational data and real world evidence, which can help clinicians understand how medicines perform across a diverse patient population outside of controlled trials. Such data may reflect prescribing patterns in different clinical practice settings, alternative doses, and differing durations of treatment, as well as comparisons between two or more therapies.
- Pharmacoeconomic information.
Insurers and drug companies agree that further dialogue between them could help address the high costs of specialty drugs, but the current limited safe harbors are preventing those discussions happening. Perhaps these principles will help to push these communications into the realm of reality.