This article provides an overview of Regulatory Advertising and Promotion (RAP) as a career in the pharmaceutical industry and discusses topics such as potential avenues for starting a career in RAP, qualities required to be successful, and some general career advice, including information on post-PharmD RAP fellowships and the benefits to be gained from serving them.
Introduction
The Regulatory Advertising and Promotion (RAP) group within a pharmaceutical company is responsible for understanding and interpreting laws, regulations, codes and guidance that govern prescription drug advertising and promotion. Those working in RAP need a thorough understanding of the regulatory landscape to ensure company compliance by providing strategic regulatory guidance for the company throughout the lifecycle of drug products. To be successful in a RAP career, it is important to possess a fundamental understanding of regulations, be able to pay rigorous attention to detail, have excellent time management skills, and have an aptitude for dealing with change. With a purpose to ensure that the right patients receive the right medication for the right reason, RAP can be an extremely rewarding career choice.
RAP Responsibilities
In many pharmaceutical companies, RAP falls within the regulatory organization, which encompasses many additional functions, such as regulatory submission management, policy and regulatory intelligence, product labeling, and chemistry manufacturing and controls.1, 2
RAP professionals have both external and internal responsibilities within a pharmaceutical company. In the US, externally they serve as the primary liaison between a pharmaceutical company and the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP). This includes involvement in the submission of promotional materials, responding to FDA inquiries, and handling other FDA-related matters. Internally, the RAP professional strategically advises on relevant laws, regulations, codes, guidance, and company policies to guide compliant growth of the business. A RAP professional also provides strategic regulatory advice for pre-and post-marketing activities where it is imperative to conduct cross-functional risk-based decision-making. Cross-functional teams may include marketing, communications, business development, research and development, sales training, medical affairs, legal, global labeling, managed markets and global regulatory. Overall, RAP professionals ensure the competitive and compliant advertising and promotion of pharmaceutical products.
To be successful in RAP, it is important to possess fundamental understandings of regulations, pay rigorous attention to detail, have excellent time management skills, and demonstrate an aptitude for dealing with change. Having a fundamental understanding of the regulations that apply to advertising and promotion lays an important foundation to support all job responsibilities in RAP. Because the regulatory landscape is always changing, it is essential to be able to embrace change, continue to learn, and promote awareness about these changes. When providing strategic advice on drug advertising and promotion, the capacity for broad thinking and attention to detail allows the individual to help ensure consistency with FDA regulations and guidances. Strategic advice is critical during various steps of the advertising and promotional journey, from ideation to creation and dissemination. Utilizing these important skills will help foster a successful career in RAP and, thus, help enable a successful and compliant business. Helping the business achieve their goals compliantly makes the RAP professional a critical and trusted internal business partner.
Starting Out
There are many potential avenues for starting a career in RAP. For example, it is possible to move into RAP if an individual currently works in another function of the pharmaceutical industry, such as medical affairs, research and development or marketing. However, one must have the key transferable skills required to be successful in RAP and, most importantly, a desire to learn. Prior experience within RAP is not always required, but taking on projects above and beyond one's current role that expose the individual to RAP, is a great starting point for learning more. Additionally, completing a post-doctoral fellowship is another way to get experience in RAP.
PharmD post-doctoral fellowship programs are aimed at furthering an individual's experience in the pharmaceutical industry through work experience and research outside of a clinical setting. The fellowships provide hands-on training in different functional areas, such as medical affairs, regulatory affairs, health economics and outcomes research and clinical operations. There are fellowship positions that focus specifically on RAP (Table A), while others broadly focus on regulatory with an opportunity to rotate within advertising and promotion. These programs range in length from one to two years at a partner company (pharmaceutical company, marketing agency, etc.), and many are affiliated with an academic institution.
Table A provides a list of PharmD Post-Doctoral Fellowship programs that focus on regulatory advertising and promotion.3-6 Note: this is not an all-inclusive list and fellowship positions will vary by year.
| Table A. Examples of Regulatory Advertising and Promotion PharmD Post-Doctoral Fellowship Programs |
|---|
| Academic Affiliation | Company | Fellowship Title | Total Duration | Duration of RAP Exposure | Additional Rotation(s) | Duration of Additional Rotation(s) |
|---|
Massachusetts College of Pharmacy and Health Sciences | Biogen | Regulatory Sciences: Advertising and Promotion Fellowship | 2 years | 15 months | US Marketing | 6 months |
Rotation of Choice | 3 months |
Purdue University College of Pharmacy | Johnson & Johnson | Advertising and Promotion Fellowship | 2 years | 1 year | Purdue University College of Pharmacy | 4 months |
FDA OPDP | 8 months |
Rutgers University, Ernest Mario School of Pharmacy | Johnson & Johnson | Promotional Compliance Fellowship | 2 years | 1 year | Healthcare Compliance | 1 year |
Rutgers University, Ernest Mario School of Pharmacy | Bristol Myers-Squibb | Regulatory Affairs: Advertising and Promotion Fellowship | 1 year | 1 year | N/A | N/A |
St. John's College of Pharmacy and Health Sciences | Allergan | Regulatory Affairs: Advertising and Labeling Fellowship | 2 years | 15 months | Regulatory Labeling | 3 months |
Marketing | 3 months |
Rotation of Choice | 3 months |
In addition to hands-on industry experience gained through completing a fellowship program, there are many other benefits. For example, these programs provide an enhanced network within the industry, academic opportunities, professional development and leadership opportunities. Fellows can network with other current and former fellows, preceptors, and stakeholders. Academic opportunities may include teaching at a school of pharmacy, preceptorship of pharmacy students, obtaining a teaching certificate, and presenting posters and publications at conferences. Some programs also may have committees within the program or partner company that allow for professional and leadership development. These benefits allow for a variety of experiences to enhance the individual's professional and personal skills required to be successful in the pharmaceutical industry.
As a current first-year PharmD Post-Doctoral Promotional Compliance Fellow at Johnson & Johnson, to help enhance my professional growth I have found it imperative to learn from others who work in the pharmaceutical industry. It is important to take all career advice into consideration, but also to determine which pieces of advice apply to the individual situation. Table B provides some general career advice and career advice specific to RAP, collected by surveying the opinions current RAP professionals
| Table B. Career Advice for Those Working in the Pharmaceutical Industry |
|---|
| General | RAP Specific |
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- Do not be afraid to make a lateral career move or demotion if this allows you to gain the skillset required for your next target career choice.
- Keep in touch with all the connections you have made throughout your career and always remember the pharmaceutical industry is a small world.
- Let others know who you are and what you bring to the table. Seek opportunities for exposure within your own department or other areas of the company external to your functional role.
- Do not be afraid to try something new if extended the opportunity.
| - Gain a solid foundation and understanding of FDA and internal company guidance.
- Learn about FDA OPDP enforcement letters to understanding how to apply FDA regulations and guidance.
- Learning about a product's history (i.e., letters from FDA, label discussions at approval, advisory comments) is crucial to ensuring promotional compliance.
- Regularly engage with the R&D regulatory affairs group to stay on top of label updates and other R&D activity.
- Take the time to learn how the business works.
- Take the time to meet your FDA OPDP partners. As a direct correspondent to FDA, building a relationship is imperative.
|
Conclusion
There is little complacency in RAP as the regulatory environment is constantly changing. In light of the constant change, the mission of a RAP professional is two-fold: to help protect the public from false and misleading advertising and promotion and also to protect the company from regulatory enforcement actions. Therefore, RAP plays a critical role in the communication of healthcare information from pharmaceutical companies to patients and to healthcare providers. RAP is an extremely rewarding career with a priority of patient safety, achieved by ensuring that the right patients receive the right medication for the right reason.
References
- What is Regulatory Affairs. TOPRA website. https://www.topra.org/TOPRA/TOPRA_Member/What_is_regulatory_affairs.aspx. Accessed 12 July 2017.
- About the Regulatory Profession. Regulatory Affairs Professional Society website. http://www.raps.org/about/regulatory-profession/. Accessed 12 July 2017.
- Biopharmaceutical Industry PharmD Fellowships. Biogen website. https://www.biogen.com/content/dam/corporate/en_us/pdfs/pharmd/BiogenFellowshipBrochure_2016.pdf. Accessed 12 July 2017.
- Regulatory Pharmaceutical Fellowship. US Food Drug Administration website. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm162733.htm. Accessed 12 July 2017.
- Partner Companies. Rutgers Pharmaceutical Industry Fellowship Program Website. https://pharmafellows.rutgers.edu/companies.php. Accessed 12 July 2017.
- Residency and Fellowship Programs. St. John's College of Pharmacy and Health Sciences website. http://www.stjohns.edu/academics/schools-and-colleges/college-pharmacy-and-health-sciences/residency-and-fellowship-programs. Accessed 12 July 2017.
About the Author
Dana Huettenmoser is a 2016-2018 Johnson & Johnson promotional compliance fellow with the Rutgers Pharmaceutical Industry Fellowship Program. Her fellowship consists of one year in regulatory advertising and promotion supporting the infectious diseases business and one year in healthcare compliance supporting the immunology business. Huettenmoser graduated from University of Connecticut School of Pharmacy with her PharmD in 2016. She can be reached at dhuetten@its.jnj.com.