Today, the wealth of information about medicines is more comprehensive and complex than ever before. Scientific knowledge and new findings go far beyond the parameters established by Food and Drug Administration (FDA) regulations and labeling. With a series of recent court decisions (Caronia, Amarin and others) calling into question these regulatory frameworks, now is the time for identifying solutions that provide physicians and patients with the best possible information on treatment options.
Last week, the Duke-Margolis Center for Health Policy released a new white paper – Policy Options for Off-Label Communication: Supporting Better Information, Better Evidence, and Better Care – that outlined the challenges of regulating health communications and stressed the urgency to arrive at a solution. The paper rightly makes the public health argument in favor of establishing a clear and effective regulatory framework for communications between biopharmaceutical companies and health care professionals.
Doctors and patients understand the importance of having access to the best, most up-to-date information about the medicines they prescribe and use. As part of that, communications with health care professionals should:
- Be based on analysis using scientifically- and statistically-sound methodologies;
- Clearly disclose appropriate contextual information about the data presented; and
- Ensure that the data presented is represented accurately.
Dr. Richard Schilsky, chief medical officer at the American Society of Clinical Oncology and a coauthor of the Duke report, said, “… sometimes only a company is aware of the full range of information that could be of benefit and should have a mechanism to convey that.”
By defining what constitutes truthful and non-misleading communications, the FDA can help support an environment of science-based dialogues between health care professionals and biopharmaceutical companies. Such communications should be based on sound scientific and statistical analysis, transparent in terms of the science and substantiation behind claims, and tailored to ensure that the message takes into account the training, expertise and capabilities of the target audience. This type of information will further provide sophisticated payers and health care professionals with the best possible knowledge for determining treatment options and choices.
This is an important matter that needs timely resolution. The courts have provided direction, the information is available today and health care professionals need the data to make the best decisions for patients. We look forward to working with all stakeholders on a common sense solution.