Editor’s Note: The promotional review process requires a critical balance between ensuring materials achieve business goals and complying with regulatory constraints. There often can be friction on the promotional review committee (PRC) between the marketing team and participants representing medical, legal and regulatory issues. But in the end, everyone has the same core objective—optimizing commercial success while keeping the company safe.
How can you reduce conflict on the PRC and work together efficiently across different functions to achieve a common goal? What are the Food and Drug Administration (FDA) regulations you need to keep top of mind when evaluating messaging—and how does the Federal Trade Commission (FTC) come into play for life sciences advertising? What are best practices for “fighting fair” on the PRC—and reaching the optimal result for your brand? Manatt provided the answers at a recent webinar, presented through PharmaVOICE. We received so many excellent questions during the program that there wasn’t time to address them all, so we have provided responses below. To view the full webinar (and earn CLE), click here to access it free, on demand. To download a free copy of the presentation, click here.
Question 1: Should members of PRCs “stay in their own swim lanes” or should they be able to comment outside of their areas of expertise?
Answer 1: PRC members can go outside their lanes—but need to pick their moments carefully. It is important that each function focus on its core responsibility and meet its primary objectives. There are times, however, when the marketing team may seek out additional information—and others should provide their feedback and insights, when marketing has indicated those additional comments would be helpful.
The PRC should set clear expectations upfront that define each person’s role—but that also have the flexibility to allow members to weigh in and provide opinions outside their lanes when that is useful and does not slow down or frustrate the business team’s efforts. Each PRC must find the right balance between ensuring members stay focused on meeting their responsibilities and creating an environment where members can have open discussions that lead to the optimal final product.
Question 2: How can PRCs balance business objectives with legal and regulatory requirements?
Answer 2: The answer is specific to each PRC team. The most important thing, however, is that every member of the PRC understand and work collaboratively toward the ultimate collective goal—effectively marketing the product while remaining compliant with applicable laws.
It is critical that the legal, regulatory and medical teams take the time to understand the business goals—and support finding ways to achieve those goals within legal and regulatory constraints. It is equally critical for the business team to appreciate the role that reviewers play in making sure that products are marketed appropriately and materials comply with legal/regulatory requirements, as well as company policies. In effective PRC committees, there is trust and candid dialogue that allow each member to understand (and not cross) the line between providing helpful feedback and interfering with meeting the team’s objectives.
Question 3: How does the claims substantiation process work?
Answer 3: The medical reviewer typically is tasked with making sure all marketing claims are clearly substantiated by reference materials. The legal/regulatory reviewers also weigh in to ensure marketing claims tie to the label information. It is essential that all claims made in promotion, whether express or implied, can be fully substantiated.
Question 4: What is the difference between promotional review for pharmaceutical products and medical devices?
Answer 4: In many ways, the review processes for medical devices and pharmaceutical products are similar. In both cases, all claims need to be truthful, substantiated and nonmisleading. Medical device and pharmaceutical ads also both need to achieve fair balance (accurately present both risks and benefits). In addition, both device and pharmaceutical companies need to be cognizant of avoiding other possible risks, such as potential violations of intellectual property, fraud or kickback laws and regulations.
There is one area where devices differ from pharmaceutical products. Devices have labels and instructions for use that cover similar ground to a pharmaceutical product’s prescribing information. Device label requirements, however, are less clearly defined. In addition, even when devices are not 510(k) approved, they are still able to be marketed. (A 510(k) is a pre-market submission to the Food and Drug Administration (FDA) to demonstrate that a device is at least as safe and effective—so is substantially equivalent—to a predicate device (one that has been cleared by the FDA or marketed before 1976.) Finally, the requirements regarding claims and strict adherence to the label are different for medical devices than for pharmaceutical products. (Access the full regulatory requirements for medical device labeling here.)
Question 5: What is “fair balance” for medical devices?
Answer 5: As noted above, fair balance for medical devices is very similar to fair balance for pharmaceutical products. The key in both cases is that any known warnings, risks, adverse events or other safety information must be presented with equal prominence as the efficacy information.
Question 6: When should press releases be treated as promotional materials?
Answer 6: Press releases should be treated as promotional material when they are making promotional claims rather than just presenting the data without commentary. Typically press releases are reviewed by a separate committee than the PRC. There is always a legal reviewer on that committee, typically the brand attorney who is closest to the data. Since press releases can be perceived as promotional, they need to be closely scrutinized for issues, such as fair balance and safety and efficacy claims.
Question 7: What are the limitations on preapproval promotion?
Answer 7: The FDA/Office of Prescription Drug Promotion (OPDP) is increasingly focusing on preapproval promotion. Preapproval promotion can occur in many different scenarios, including but not limited to investor relations, discussions on pricing and health economics and outcomes research (HEOR) data, and dissemination of early-stage research. It is important to avoid definitive claims of efficacy or safety before a final label has been approved. It is also important to be aware of the recent provider and payer guidance documents (designated by the FDA as CFL Guidance) from June 2018, which provide greater flexibility for preapproval communication—but still include many limitations and requirements.
Question 8. Should social media be reviewed by the PRC?
Answer 8: Yes, the PRC should review all social media, including company-sponsored website posts, data, website structure and metadata. Social media includes messaging on websites the company owns or controls, as well as on social media platforms, such as Facebook, Instagram and Snapchat. The need to respond to and control posts on company-sponsored or hosted sites presents a new and complex set of challenges. Companies should review their sites frequently to limit and ensure they correct any inaccurate data being posted.