Most pharmaceutical companies have interdisciplinary committees with regular team meetings to discuss and review promotional material. Promotional review committees (PRCs) serve an essential function for pharmaceutical companies. They review all forms of advertising and promotion for medical accuracy, completeness, and realism, as well as for legal and regulatory compliance with the FDA and other authorities. PRCs also ensure compliance with company policies, voluntary industry codes, and anything that might create liability risk for the company, patient privacy and content issues.
In addition to advertising and promotion, PRCs may also review unbranded, disease-state information and internal communications that describe marketing strategies or provide direction to the sales force. PRCs touch many parts of the organization, not only sales and marketing, but also R&D and health economics and outcomes research. Integrating data from clinical trials and other sources into advertising and promotion is one of the primary functions of PRCs.
PRCs must perform flawlessly, otherwise companies run the risk of receiving an enforcement letter from the FDA’s Office of Prescription Drug Promotion. Enforcement actions undertaken by the FDA may spark investigations by the Department of Justice, sometimes resulting in significant fines, reputational harm to pharmaceutical companies and the industry, and corporate integrity agreements that impose additional processes and restrictions on companies.
I have served on many PRCs in different therapeutic areas across several companies. Here are some issues I have found critical to achieving high-performing teams.
1. Find a common voice. Given the diverse training and background of individuals who typically comprise the PRC – doctors, pharmacists, lawyers, and others -- it is nearly impossible to obtain one writing voice among team members. Yet, word-smithing advertising copy or writing copy during team meetings takes up valuable time. PRC meetings should be spent optimizing claims and the promotional value of marketing material rather than wasting time on rewrites. PRCs should employ an editor to handle the “King’s English,” and any changes in advertising copy should be made only when absolutely necessary, as opposed to discretionary. No two people have the same writing style, so teams should not deliberate on minor differences in wording that say essentially the same thing. Be brief, be brilliant, and be gone!
2. Respect everyone’s opinion. Differences of opinion among members of the PRC are inevitable. Although it is necessary to discuss these differences in team meetings, ultimately the PRC as a team is accountable for resolving any disagreements. Medical, legal, and regulatory team members must learn to trust each other and rely on the expertise of the individual in whose discipline the controversy lies. Occasionally, highly contentious or risk-management issues may be escalated to an “executive” PRC to overcome an impasse, but no one should ever be insulted or attacked for his or her opinion. Collegiality must prevail in all instances.
3. Create dedicated roles. Team cohesiveness develops over time, especially when dedicated positions are created on PRCs for each team member. A rule of thumb is that every hour spent in team meetings requires approximately 2 hours of individual review time before the team meets. Thus, for a team that meets 6 hours per week, each team member should plan to devote 12 hours of review time outside team meetings. This would be approximately the equivalent of half-time position, assuming a 37.5 hour work week.
4. Maintain consistency. Continuity of team members from meeting to meeting is important. If there is a different representative from any discipline on Tuesday versus Thursday, additional work and revisiting of position will occur. Product managers, who are vital to PRCs, should be held accountable for carefully reviewing all material before it is submitted to the PRC to ensure consistency with prior decisions. Rules that guide the decision-making process in PRCs should be applied consistently within and between teams.
5. Manage team turnover. PRCs should be aware that a change in team composition due to turnover may create friction or change the chemistry of the team. PRCs should approach such a change with patience, helping to on-board new members while remaining receptive to their suggestions. PRCs should refrain from responding negatively to new members. “That’s not the way we do it” -- and other dismissive messages -- are hurtful and unwelcoming. It is easier for teams to disregard feedback they don’t agree with than hold themselves accountable for change. By the same token, new team members should keep in mind that their entry may cause apprehension or alarm in existing members. New team members should bring skills and experience from previous positions, but they should not boast how a previous employer allegedly did things better.
6. Balance autonomy and teamwork. To be effective, PRCs must work diligently with a relatively high degree of autonomy. Otherwise, team meetings may become suboptimal, bogged down by inefficient operations, potentially creating tension among team members and possibly compromising the integrity of the promotional review process. PRCs walk a fine line, because the workload is divided among team members from various disciplines who work independently, yet they must function as a unified team. A purely “divide and conquer” approach, wherein individual team members work in a silo and seldom meet face-to-face, cannot be sustained.
7. Lead and influence. Even though PRC members are trained to be autonomous, promotional review is like a team sport, requiring the ability to be both a team leader and a team player. Conflicts and “turf” battles often arise as to who has the final say in team meetings. The truth is, although PRCs commonly fall under the leadership of regulatory affairs departments, a case can be made for medical and legal departments to govern PRCs. Unless team members accept their roles as both a team captain and a team member, and know when to exert their authority and when to acquiesce, dissention will ensue. Team members must also learn to appreciate the differences between authority and leadership and how to influence others to change from the status quo. Leadership should be viewed as a personal quality that enables an individual to influence others, independent of positional authority or the ability to reward or punish others.
8. Adhere to timelines and deadlines. PRC meetings should start and end on time. The meeting agenda should estimate the time required for each job and avoid squeezing too many jobs into the allotted meeting time. Jobs should be prioritized by a marketing operations committee well in advance of team meetings. Generally, all material should be submitted a full week before it is expected to be discussed in team meeting. In this way, PRC members will have ample opportunity to review the material before the team meets. “Rush” jobs and jobs that require expedited reviews are to be expected from time to time -- for example, press releases and updates to the prescribing information. Thus, the agenda should allow some flexibility, but it should not become a moving target in which jobs are constantly rearranged or changed at the last minute.
9. Conduct all relevant business in team meetings. The goal of the PRC is to make clear and responsible decisions by having all the necessary medical, legal, and regulatory personnel and resources in place during the team meeting. Working excessively offline, between team meetings and on weekends, may signal a dysfunctional team. Responding to excessive e-mails and “copying all” can become fatiguing and disrupt the flow of material into an otherwise healthy PRC. Team morale can become deflated by incessant job changes and requests for job approvals outside team meetings.
10. Strive for economies of scale. In the traditional business model, PRCs are constituted around marketed products. In this model, the PRC reviews jobs that are designed for both healthcare professionals and consumers, but there is usually only one dedicated team per product. An alternative model is to segment PRCs into “healthcare professional” and “consumer” teams. In this model, each team is responsible for reviewing two or more products, potentially achieving greater economies of scale (fewer overall PRCs). A third team – the “disease state” team – could be tasked to review information promoted to increase awareness of diseases for which the company has marketed products.
11. Innovate. Every member of the PRC is expected to review his or her job individually, before the scheduled interdisciplinary PRC meeting. However, a different method may be better suited for some jobs, for example, jobs that are heavily weighted toward one discipline -- medical, legal, or regulatory – and jobs that were previously reviewed at a “live” meeting and require a “second look” by only one or two team members for final approval. Likewise, new marketing concepts are probably best discussed in a forum other than the PRC, because only one or two PRC members may be necessary to provide specific feedback requested by the project originator. Select individuals may know potentially viable ideas in compliant terms from the outset, reducing the number of “non-starter” concepts. The project can be reviewed by the full team once the concept is fully “baked” and the job has been submitted to the PRC.
12. Include additional personnel in team meetings as necessary. PRC meetings are often slowed down by lengthy discussions in the absence of important stakeholders who can shed light on the nature of the job. These stakeholders, often from marketing, sales, or sales training, usually have the answers to questions such as, “How will this article reprint be distributed to healthcare professionals?” “Will this brochure be too complex for consumers to understand?” And, “Who is the intended audience for this visual aid – healthcare professionals, managed care organizations, consumers, or others?” PRCs must make decisions not only about the medical, legal, and regulatory ramifications of marketing material, but also about the “taste and tone” of advertising and whether approved marketing items can be responsibly executed in the field. Input from non-core team members may be helpful in this regard.
13. Take the guesswork out of work. In addition to marketing and sales personnel, the attendance of marketing agencies may be required at PRCs. Their presence may be especially helpful when understanding marketing projects in the digital realm or when fulfilling multicultural marketing initiatives. Because the latter often require translation (and accurate back-translation) of content from English to another language, it may be desirable to have a certified translator attend the PRC meeting. There is no reason a PRC should have to make assumptions about questions other people can readily answer.
14. Delegate with authority. It should be incumbent upon all team members, including project originators, to find qualified and knowledgeable substitutes to attend team meetings in their absence. Alternatively, absent members could attend the PRC “virtually,” using any number of web-based applications to collaborate with the team. In any case, whoever is participating in the PRC should be able to represent their discipline and should be empowered to make final decisions on all but the most difficult issues.
15. Embrace the digital domain. Finally, PRCs must learn to adjust to the digital promotional age in order to evaluate proposed tactics and strategies in this realm. They must champion new technology designed to enrich traditional marketing channels and relationships with customers. However, because it is unlikely that regulatory authorities will carve out the digital domain from the regulations that apply currently to print and broadcast material, PRC members will need to sharpen their digital skills, and teams may need to add specialized members or partner with niche companies specially equipped to work with PRCs in areas critical to the future of e-promotion – namely, the use of social media and internet-connected devices such as computers, tablets, smartphones and game consoles to engage consumers and providers with online advertising. PRCs must have mechanisms in place to track changes in the various social media platforms that alter their programs regularly, often without much notice to the advertisers, and sometimes without a strong understanding of the regulatory implications.
In my experience, by following these basic principles, PRCs should be able to produce a quality product while working in an atmosphere of trust and respect. Equally important, the output of the PRC, whether a sales aid, journal ad, website, television commercial, or advertising through in any other format, should be medically and legally sound, capable of meeting the requirements of regulatory authorities in the host country. The ultimate goal of such a team should be the creation of a finished product which provides accurate and complete information to guide the prescribing physician or the patient in utilizing the advertised product to achieve desired health outcomes.
Arthur Lazarus, MD, MBA is senior medical affairs director at Shire Pharmaceuticals in Wayne, Pennsylvania. Dr. Lazarus is a previous contributor to Pharmaceutical Executive. His opinions are his own and not necessarily those of Shire.
Contact Information :
Arthur Lazarus, MD, MBA Shire Pharmaceuticals 725 Chesterbrook Blvd. Wayne, PA 19087-5637
Tel: 484 595 1435 Fax: 484 595 8658 E-mail: [email protected]
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