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8 Key Takeaways from the DIA Advertising and Promotion Regulatory Affairs Conference
The DIA Advertising and Promotion Regulatory Affairs Conference brought together leaders from FDA, industry, and academia in Washington, DC to discuss the current regulatory landscape of pharmaceutical advertising and promotion.
New regulations, changing landscapes and the emergence of new advertising and promotion tactics made for an information-packed three days. Check out these eight key takeaways from the meeting:
1. Information conveyed to health care professionals and patients must be accurate, non-misleading, balanced, and high-quality. Consider how you present information to your audience. Claims should be appropriately referenced and contain the necessary risk information. For example, ensure there are no distractions (audio/visual) during the communication of risk information in direct-to-consumer advertisements. Also, communicate risk and safety information appropriately when advertising and promoting animal drug products because drugs used in food animals can produce residues if used incorrectly.
2. Take a proactive approach with FDA. Submit advisory opinion requests to the appropriate office to address questions prior to submission. Refer to FDA’s website, specifically the OPDP or APLB for additional information on submissions.
3. The range of information generated to inform stakeholders, including journal articles, clinical practice guidelines, clinical trial data, post market safety and effectiveness data, real-world evidence, and economic impact information, often goes beyond what is written on the label. Therefore, consider FDA’s three-factor approach when assessing if your communication is Consistent with the FDA-required Labeling (CFL). A communication is CFL only if it answers all three questions:
- How does the information in the communication compare to information about the conditions of use in the product’s required labeling?
- Does the information in the communication increase the potential for harm to health relative to the information in the labeling?
- Do the directions for use in the required labeling enable the product to be safely and effectively used as suggested in the communication?
For additional information, review the FDA draft guidance Medical Product Communications That Are Consistent With the FDA-Required Labeling, which is open for comments until April 19, 2017.
4. The FDA OPDP Research Team conducts social science research to help identify barriers and develop solutions to carrying out OPDP’s mission of 1) protecting the public health by assuring prescription drug information is truthful, balanced, and accurately communicated; and 2) guarding against false and misleading advertising and promotion through comprehensive surveillance, enforcement, and educational programs.
5. FDA’s Office of Medical Policy Initiatives discussed the issuance of a proposed rule that would establish a new Patient Medication Information framework. Under this guidance, companies would submit an abbreviated one-page document which highlights the most important information for patients about a prescription drug. Learn more from this post by the Office of Management and Budget.
6. There are still many unknowns related to off-label communication with payers. Speakers noted that we still need a definition of “scientific exchange” as well as clarification on the scope of information to include when disseminating health care economic information. For example: Do firms need to include every piece of contextual information listed in the draft guidance? Are firms even able to provide it all? Looking to add your perspective? You can submit comments on the FDA draft guidance Drug and Device Manufacturer Communications With Payers, Formulary Committees, and Similar Entities by April 19, 2017.
7. Compliance for digital promotional tactics should be addressed by a cross-functional team consisting of marketing, medical, legal and regulatory. Use of digital promotion tactics is expanding to various channels, and communication between these cross-functional partners is critical to the development of accurate, non-misleading, balanced, and high-quality digital promotional tactics.
8. Communication or activity that is promotional can also be educational—but it must be compliant. For example, Patient Support programs may have some promotional aspects, and these programs may exist for the following reasons:
- Educate patients about a product or disease
- Facilitate access for prescribed patients
- Support safe use of the prescribed product
- Improve patient outcomes
- Reduce overall health care costs.
More compliant, health literate, educational content communication hopefully equals:
- Better compliance with the law
- Better informed patients and caregivers
- Lower cost throughout the entire health care system
Want to continue this conversation? Join DIA’s Advertising and Promotion Working Group or join us at the DIA 2017 Global Annual Meeting in Chicago.