Starting out as an ad promo reviewer

Feature ArticlesFeature Articles | 28 December 2022 | Citation

This article provides a brief overview of what to expect when starting out as a regulatory advertising and promotion (ad promo) reviewer and includes recommendations for some basic introductory resources.
 
Keywords – advertising and promotion, regulations, reviewing, starting out
 
Introduction
Regulatory ad promo review is more an art than a science, and learning how to apply the specific laws, regulations, and guidances is an ongoing process. There is a lot of grey space in which the reviewer must weigh how the laws and regulations from the 1960s might apply to modern technology or how the spirit and purpose of those regulations apply to an ever-changing, technologically driven media environment. Truthful and accurate promotion that does not mislead and that protects patient safety is at the core of what reviewers do. They work with marketing teams to craft engaging, informative, and compliant ad promo pieces to ensure the consumer’s thorough understanding of the drug product. One must also be able to navigate difficult conversations, nurture cross-functional relationships, and consider pieces from the perspective of a third-party such as a consumer, healthcare provider, or the US Food and Drug Administration (FDA).
 
Resources
Laws, regulations, guidances
The Federal Food Drug and Cosmetic Act1 was passed in 1938, giving the FDA the authority to regulate food, drug, and cosmetic products. The act has been amended multiple times, including in 1962, when Congress granted the agency the authority to regulate the promotion and advertising of prescription drugs;2 in 1997, with the FDA Modernization Act;3 and 2016, with the 21st Century Cures Act.4 The laws give high-level authority to the FDA to regulate; the agency writes regulations and guidance documents to establish and communicate its interpretation of those laws.
 
The Code of Federal Regulations5 codifies rules published in the Federal Register, which is updated annually. The regulations that are most directly related to advertising and promotion are published under Title 21 (Food and drugs),6 Chapter 1, in:
 
  • Subchapter C (Drugs: General), Part 202 (Prescription drug advertising),7
  • Subchapter D (Drugs for human use), including Part 312 (Investigational new drug application)8 and Part 314 (Applications for FDA approval to market a new drug),9 and
  • Subchapter F (Biologics).10
 
There are many other regulations that may also have an impact on advertising and promotion, such as those on labeling.
 
The FDA publishes guidance documents that provide additional interpretation of the regulations and laws. These documents are a mix of draft and finalized guidance documents, but collectively they provide a framework for the advertising and promotion of prescription drugs. Some of the key guidances address issues such as disclosure of risk information, providing submissions to FDA in both electronic and nonelectronic formats, ensuring communications are consistent with product labeling, communication with payors and formulary committees, and character space-limited media platforms, among others.11
 
Other documents must also be considered. For example, if a company is a member of, or follows the code of, the Pharmaceutical Research and Manufacturers of America (PhRMA), there are codes and guidelines that may have a bearing on advertising and promotion. For instance, PhRMA guiding principle 8 in the direct-to-consumer (DTC) guideline states that, “Companies should submit all new DTC television advertisements to the FDA before releasing these advertisements for broadcast.”12 By using the advisory comment submission process offered by Office of Prescription Drug Promotion (OPDP), a company can get feedback on the direction taken with a television advertisement, which may result in a stronger ad at the end of the process. This is not mandated by the FDA, but rather, part of the code that PhRMA has established to advocate for patients to have informed conversations with their healthcare providers.
 
Databases, warning letters, industry groups
The laws, regulations, and guidances are all foundational to the role of a regulatory ad promo reviewer. Learning and understanding how to apply all of those takes time and experience. OPDP’s database of untitled and warning letters is a useful resource for understanding the office’s view on advertising and promotional pieces. These letters are public (with proprietary or confidential information redacted) and are posted along with the violative material.13 It is a rich source of ad promo information, providing insight into how OPDP reviews the materials and, when viewed over a number of years, shows trends for which violations have been cited most frequently. 
 
Industry groups, such as the Regulatory Affairs Professional Society Regulatory Exchange platform or the Drug Information Association Advertising and Promotion Working Group, are also valuable ad promo resources in that they provide an assembly for sharing and discussing learnings and information. Regulatory practice can be nuanced, so getting other points of view and learning about others’ experiences as a way to inform decision making is invaluable. Regulatory ad promo is a small section of regulatory practice. Reviewers across the section likely are making similar decisions on a daily basis, so if a high-level question goes out to the community, chances are someone else will have experience with that type of decision.
 
Other considerations
Asking questions is the best way to learn about and understand the role of the ad promo reviewer. The ad promo community, marketing partners, and fellow reviewers are all important sources of information and practical, hands-on advice. The more information a reviewer has, and the more understanding there is of what marketers are trying to accomplish, the better informed a decision will be.

Asking questions can also provide a helpful grounding for a reviewer when trying to offer a solution. For instance, if a claim in the current piece is not supported by the references offered, a different reference might be more helpful. Other questions could uncover issues that need to be addressed such as a potential regulatory concern with the function of a social media platform, a potential two-way interaction between a rep and a doctor that needs further resource support, or changes a vendor could make to their advertising platform.

Everyone is being asked to do more with less time and fewer resources, but with higher return on investment. This can exacerbate the standard push and pull between marketing and regulatory, and create friction. Teams need to work together to solve ever-changing and more complex advertising needs for different platforms. All reviewers, new and experienced, need to have patience with themselves and each other. Ad promo reviewing can be overwhelming in the beginning. Understanding a company’s risk tolerance, learning a product’s history and data, understanding the application of balance, and learning how to review a piece all occur in a pressured environment in which details matter. It takes time and patience to learn.
 
Relationships within the ad promo team and with other teams, especially marketing, are important. There is a natural and healthy tension between marketing and regulatory because both departments have necessary roles that do not always align within the vision of execution. Ad promo reviewers can also contribute to other sections of the company such as labeling development, clinical protocol development, and evaluation of business development decisions. It takes much effort and ongoing work to demonstrate the value of the ad promo reviewer to other departments and to get them to view regulatory as a partner rather than an obstacle. The earlier a reviewer is involved in projects and marketing pieces, the more impact they can have. Early guardrails or advice can save companies time and money. For example, when a company is developing a phase 3 protocol, an ad promo reviewer can provide insight to what claims the endpoints may support (assuming the trial goes according to plan). How the marketing department wants to position a product and what claims the department wants to make can be significantly affected by how the company studies the drug. Having an ad promo reviewer involved in the protocol development can help prevent a situation in which the marketing department wants to make claims that are not supported by the phase 3 protocol construction and endpoints.
 
Reviewers should establish a pattern in the way the review is conducted. Everyone goes about their reviews slightly differently, prioritizing, evaluating and relying on their instinct based on their experience. There are not necessarily a lot of “right or wrong” answers or decisions. Understanding how to think through concerns is key to developing a template for decision making. The answers to and outcomes of an issue may not always be the same, but consistency in approach is helpful for reviewers and the marketers or partners. Reviewers need to establish what information is needed, what gets looked at first and whether it should be reviewed a couple of times to see if a viewpoint changes, whether consultation from another department is needed, and whether there is a checklist for the basic stages and elements of the review.
 
Conclusion
Being a regulatory ad promo reviewer is a highly rewarding career path. The role rests at the nexus between science and the consumer, whether that consumer is a patient, a healthcare provider, or a formulary committee. Reviewers help educate and inform. Patient safety is central to the reviewer’s role, but they also help protect the company doing the educating. Truth and accuracy in promotion that does not mislead the patient is at the core of what reviewers do.
 
Developing a foundation in the laws, regulations, and guidances is critical to success in the role, but just as important is an ongoing sense of curiosity and willingness to keep learning. Technology and media platforms change and are updated all the time, marketing has innovative ideas and new ways to reach customers, new data are generated, and societal changes transform how people receive information. Within this dynamic ad promo context, it is important to seek out others’ input and perspectives, find a mentor, and never stop asking questions.
 
Abbreviations
DTC, direct to consumer; FDA, [US] Food and Drug Administration; OPDP, Office of Prescription Drug Promotion; PhRMA, Pharmaceutical Research and Manufacturers of America.
 
About the author
Heather McFalls, MSJ, is a director of regulatory advertising and promotion at Organon. She has 15 years of experience in the industry, focusing on labeling, risk evaluation and mitigation strategy, and advertising and promotion review. McFalls has a master of science of jurisprudence degree from Seton Hall University School of Law, a postgraduate certificate in regulatory affairs management from University of California at Irvine, and a bachelor of arts degree from Pennsylvania State University. She can be reached at heather.mcfalls@organon.com
 
Citation McFalls H. Starting out as an ad promo reviewer. Regulatory Focus. Published online xx December 2022. URL.
 
References
All references last accessed and/or verified on 15 December 2022.
 
  1. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act (FD&C Act) [reference information]. Last updated 29 March 2018. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
  2. US Congress. Drug Amendments [Act] of 1962. https://snrdf5.p3cdn1.secureserver.net/wp-content/uploads/2014/12/Kefauver-Harris-Amendments-Public-Law-87-781.pdf
  3. US Congress. Food and Drug Administration Modernization Act of 1997. https://www.govinfo.gov/content/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf
  4. US Congress. 21st Century Cures Act. Published 2016. https://www.congress.gov/bill/114th-congress/house-bill/34
  5. Code of Federation Regulations. Last updated 28 November 2022. https://www.ecfr.gov/
  6. 21 CFR. Food and drugs. Current as of 13 December 2022. https://www.ecfr.gov/current/title-21
  7. 21 CFR. Part 202. Prescription drug advertising. Current as of 13 December 2022. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-202?toc=1
  8. 21 CFR. Part 312. Investigational new drug application. Current as of 13 December 2022. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312 
  9. 21 CFR. Part 314. Applications for FDA approval to market a new drug. Current as of 13 December 2022. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314?toc=1 
  10. 21 CFR. Subchapter F. Biologics. Current as of 13 December 2022. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F 
  11. Food and Drug Administration. Search for FDA guidance documents. Last updated 29 November 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents#guidancesearch
  12. PhRMA. PhRMA guiding principles direct to consumer advertisements about prescription medicines. Published 2018. https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA_Guiding_Principles_2018.pdf
  13. Food and Drug Administration. Warning letters and notice of violation letters to pharmaceutical companies. Last updated 3 August 2022. https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies
 
 

 

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