- Speech by
Lauren Silvis, JD
Chief of Staff - Office of the Commissioner
DIA Advertising and Promotion Regulatory Affairs Conference
(Remarks as prepared for delivery)
Commissioner Gottlieb often notes that at FDA, we’re witnessing a period of historic scientific advancement. We’re seeing unparalleled medical progress. We know that the opportunities we have, across our entire portfolio, to promote health and wellbeing, far exceed any comparable period of technological change. The rapid pace of innovation requires FDA to also modernize our own policies, to make sure we can fully leverage these opportunities. We must be flexible enough to adapt to evolving science and new approaches, while ensuring that we maintain our gold standard of public health protection.
Our commitment to modernize certainly holds true when we consider our policies regarding labeling, advertising, promotion, and other communications about medical products.
FDA’s role in evaluating the safety and effectiveness of medical products has not changed, nor have our standards to protect patients. We recognize, however, that information can develop rapidly. There’s information that’s valuable to patients, providers, and payors that might not be included in the product’s labeling. This new information might help advance our public health goals if it’s presented in a truthful and non-misleading way, with proper context. FDA must help ensure that valuable information about the medical products we regulate is available to those who need it to improve health and well-being.
Across our medical product centers, we’re taking important steps to ensure that labeling effectively communicates well-curated, up-to-date information; that rules relating to advertising and promotion are clear, thoughtful, and well-tailored; and that we are providing clear and helpful guidance on how to communicate truthful and non-misleading information about regulated products. We’re committed to being more transparent about our thinking on these important issues.
I know there’s great interest (at least in this room) in where FDA policy is headed on labeling, advertising, and other communications about medical products. Given the public health importance of these issues, we’re going to be prioritizing this work, and focus on applying our authorities and providing recommendations to help advance patient outcomes and promote patient safety.
We’re moving forward with our work on the definition of intended use, taking into account the feedback we received. When we indefinitely stayed certain changes to our definition of “intended use,” we also acknowledged that how FDA determines the intended use of a product is a fundamental principle that has significant implications regarding the scope of FDA’s regulatory authority. And that, in turn, has significant implications for how we carry out our role to protect the public health. Clarifying the approach is a priority for FDA, as our clinicians, scientists, attorneys, policymakers, and other professional staff consider the comments received in this rulemaking and pursue next steps.
At FDA, we’re working to identify other areas where guidance would be useful to ensure manufacturer communications about emerging scientific data is provided with appropriate context and in a truthful and non-misleading manner. Over the years, there have been calls for us to issue guidance on scientific exchange. We’re considering the best way to be responsive to those questions, and how to prioritize and efficiently tackle these issues. We’re also carefully considering comments on draft guidance documents we have previously issued.
One of our priorities in the coming months will be issuing guidance on labeling considerations intended to reduce medication errors, which is a serious public health concern for the Agency. We also plan to provide guidance on product naming and specific sections of the prescribing information – to help providers locate the important information they need to help select the appropriate medical products for their patients.
Finally, I want to call attention to statements comparing biological reference products and biosimilars. We have heard the argument that some of these statements may be intended to undermine public confidence in FDA licensed biosimilars and therefore deter competition. We have serious concerns about these practices, and their negative impacts on public health. In the emerging paradigm of biosimilar and interchangeable products, we want to ensure that providers and patients are receiving useful information about these products that can offer a safe, effective, and more affordable treatment option. We’re going to be taking new actions to support appropriate adoption of biosimilars, stop any false or misleading promotion about biosimilars, and address some common questions about promotional materials involving biosimilars.
The plans I’ve described build on the important work we’ve recently undertaken to address medical product communication, including issuing two final guidances to provide clarity to manufacturers on ways they can communicate, in a truthful and non-misleading manner, certain information about their products. FDA recognizes that payors need access to the latest evidence about medical products to make coverage and reimbursement decisions for their insured patients. Our final guidance for manufacturers on communicating health care economic information about their products with these entities is a key step toward supporting value-based healthcare. The final guidance also addresses some common questions related to providing payors with information about medical products that are not yet approved or cleared for any use, and providing information about unapproved uses of approved or cleared products.
We also finalized guidance on communications that are “consistent with the FDA-required labeling,” which provides answers to commonly asked questions on how firms can communicate data and information about their products that are not in the FDA-required labeling. This guidance considers multiple factors to determine whether these communications are “consistent,” looking at how the information in the communication compares to the conditions for use described in the FDA-required labeling, the potential for harm and whether the product’s approved labeling enables the product to be safely and effectively used as suggested in the communication.
We’ve focused on providing additional guidance to applicants on how to develop labeling for medical products that clearly conveys important information to providers. For example, we finalized guidance documents on labeling biosimilar products and products approved under the accelerated approval pathway. Additionally, we issued draft guidances on discrete topics (such as statements in labeling about gluten content and child-resistant packaging) and guidances with recommendations for preparing specific sections of the prescribing information – such as the Indications and Usage section and certain required elements in Highlights. Our goal in publishing each of these guidances is to provide detailed recommendations to industry as they curate the labeling information for their medical products.
Finally, I want to highlight our work to help guide how manufacturers can most effectively share information with consumers. Our draft guidance outlining recommendations for firms that include quantitative efficacy and risk information in direct-to-consumer promotional materials provides important suggestions to make that language and presentation more consumer-friendly. As with all of our efforts, FDA’s decisions are guided by the latest science. To that end the research team within our Office of Prescription Drug Promotion has initiated or plans to initiate a number of research studies on product communications. We’re currently looking at issues related to the framing of risk information in promotional materials, including the amount and location of that risk information; we’re also studying the use of disclosures in conjunction with various types of medical product communications to ascertain how those disclosures impact audience perception and comprehension of the communicated information. The results of these studies will contribute to the body of knowledge that informs our ongoing policy development and help ensure that they are based on sound science.
Thank you for having me here today and allowing me to provide you with this update on FDA’s activities. I look forward to taking your questions.