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RAPS' Latest | 18 October 2018 | By Steve Jwanouskos
After more than three decades of working directly with the development, approval or clearance and subsequent commercialization of medical technologies, I made the switch to advertising and promotion regulatory review. For anyone considering a similar move, I have some advice: Go for it!
Making the transition to any new job—regulatory or otherwise—can be challenging, but I found I was able to make the move more smoothly and effectively by following some simple steps in my first 90 days on the job. I found this idea and other helpful advice for developing and honing the job transition in a well-organized book titled, The First 90 Days, by Michael D. Watkins, from which I adapted the title for this article. What follows is based on my own personal experience. The opinions offered herein are my own and do not reflect those of my employer or any other third party.
First, before doing anything, I focused on just observing. During those first 90 days, I got to work every day at 7:30 am and stayed until 5:30 pm. I Tried to work at peak efficiency all day from prioritized to-do lists, always keeping in mind what I needed to do next. One of the most important things I did was to cultivate as many work connections as possible.
To help cultivate connections, I put out a candy jar and spent freely to fill it up with the really good stuff. To do this, I used my own money. I viewed it as an investment in my future, and the future means the 90 days that follow those first 90 days, and the 90 days after that and so on. After about a week, I put a sign on the candy jar, “You can have all the candy you want, but you have to introduce yourself.” Most, if not all of my new colleagues took advantage of the free candy and the opening for an introduction.
The purpose of the candy jar was not to become the most popular person in the organization, but to learn about those who are the more successful, who stand out for their institutional knowledge and their positive demeanor, those who work well cross-functionally and, therefore, know who’s who. In the first 90 days, I aimed to accelerate my learning by associating with those who would be able to teach me what I needed to know and those who could help reveal what I did not know, which is impossible to learn on one’s own. I knew that then, and only then, would I be nearing the time when I would begin earning my paycheck by contributing to the organization in a meaningful way.
I also sought valuable advice from professionals who have excelled in the field of advertising and promotion for a long time. One such colleague, Linda Pollitz, a senior director of regulatory affairs, advertising and promotional labeling, provided me with a valuable reading list of guidance documents listed at the end of this article. To those sources, I would add a new guidance document that was just published in June 2018, entitled Guidance for Industry: Consistent with the Labeling. Each of these guidance documents are a must-read, especially for rookies in advertising and promotion like me. The quest for new knowledge is an important step and a major theme of this article.
It is critical to approach the first 90 days with integrity. I wanted to immediately establish my integrity as an essential element of my work and reputation. I found a great definition of integrity in the reminder the US Marines have at their departure point, Parris Island, SC. There, Marines are reminded before they deploy into harm’s way to, in descending order of importance to:
Tell the truth.
Do the “difficult right,” not the “easy wrong.”
Think of the group before yourself.
Do not whine or make excuses.
Only judge others on actions, nothing more.
No matter how trivial the task, do your best at it.
In my opinion, following these standards in the first 90 days and beyond is vital—whether in the Marines, medical products advertising and promotion or any other field.
For the specific skills to develop early during a transition to advertising and promotion, I asked the advice of an industry expert, Stella Li, department head, Advertising and Promotion Regulatory, Johnson & Johnson Vision. My first question was about what to expect as the biggest difference from my previous regulatory background, and how to adapt to it to be successful. Her advice was to recognize that review of advertising and promotions is “a work of art.” She pointed out that the same message can be stated in a variety of ways, sometimes with just a subtle change in the nuance of an expression or a phrase. Consistency is the best one can strive for in this field, because there can be so many “shades of gray.” Most standard operating procedures (SOPs) are not exhaustive (nor should they be) to be so prescriptive that there will be guidelines to follow. However, FDA guidances are very helpful for developing a consistent basis upon which to provide reliable reviews.
Other skills Stella identified as key to success were paying attention to detail and the ability to articulate the foundations of any given position. Being able to articulate not only my point of view, but also that of colleagues in other, related areas like marketing, helps me to gain a broader negotiating perspective, and minimize confusion, which John E. Abele, co-founder of Boston Scientific Corporation, once told me was the “arch-enemy.”
To achieve success in regulating advertising and promotional claims, Stella advised that being able to work cross-functionally is paramount to “reaching compliance alignment while allowing effective messaging.” Customers—both healthcare professionals and patients—are the at center of creating effective messaging, which is why everyone in senior management, advertising and promotion and marketing, among others, should care about what is being said and how. Intrinsic in the pursuit of compliant and effective messaging will be disagreement. Disagreement should be recognized as part of a process to resolve things, and one should not take it personally.
During my first 90 days, I started by observing, learning and “devouring” seemingly endless SOPs. I don’t think memorizing SOPs word-for-word is necessary, or even advisable. Instead, I would make it a point to have a copy of the released procedure where I was able consult it frequently. I would recommend getting to know the two top SOPs backward and forward, especially during those first 90 days.
It also is important to have an early “sit-down” with one’s boss to discuss top priorities, both short- and long-term, to see how and where they fit with those of the organization. Putting everything into context (“orientation”) is the next step after observing. I followed a process of observing, orienting, deciding and acting, a four-step sequence attributed to US Air Force Colonel John Boyd, and covered well in Robert Coram’s book, The Fighter Pilot Who Changed the Art of War.
To summarize the idea, observe in a detached, objective manner searching for substance over style while looking for actions, not necessarily words, even if advertising and promotion involves primarily words. It is possible to orient by putting the flood of new information into meaningful context, so patterns and tendencies can be identified. Allow your perspective to be grounded in science. Your decision, supported by as much fact and data as possible, should be brought forward to the team as one option. Offer support regarding why you think this is the best option by using examples and appropriate details, possibly also demonstrating the weaknesses of other, less favorable approaches. Finally, act with clear purpose in executing a plan that includes the next step. Act decisively, without the dreaded “unforced error” fear that often plagues tennis players. Do not be the center of a spectacle, major or minor. I strived to apply these methods during my first 90 days and then continuously thereafter. The faster these four methods—observe, orient, decide, act—are accelerated, the easier the job becomes.
At the end of my first 90 days, I was looking forward to my next 90 days, when my focus would shift from making the job transition to delivering for the organization. Advertising and promotion is a fascinating, important role for a regulatory professional as one will likely be exposed to the newest ideas—some permissible and some requiring a little revision and assistance. In this role, it’s possible to become recognized as a leader in the organization, which certainly is a nice extra perk. But it is important to always remember that authority and responsibility travel together. You can delegate your authority, but not your responsibility.
Coram R. Boyd: The Fighter Pilot Who Changed the Art of War (Biography). 2002. Little, Brown. New York, NY. ISBN 978-0-31679-688-0.
Watkins MD. The First 90 Days. Proven Strategies for Getting up to Speed Faster and Smarter. 2013. Harvard University Press. Boston, MA. ISBN 978-1-4221-8861-3.
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs Guidance for Industry (April 2015). [Author’s Note: guidance is primarily intended for pharmaceuticals, but premises asserted by FDA also may be applicable to medical devices].
Memorandum: Center for Drug Evaluation and Research, Food and Drug Administration, January 2017. Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.
Medical Product Communications That are Consistent With the FDA-Required Labeling—Questions and Answers. January 2017. [Author’s Note: superseded by number six].
Medical Product Communications That are Consistent With the FDA-Required Labeling—Questions and Answers. June 2018. Drug and Device Manufacturer.
Communications with Payors, Formulary Committees and Similar Entities—Questions and Answers. January 2017.
Guidance for Industry: Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs Guidance for Industry. April 2015.
Guidance for Industry: Internet and Social Media Platforms-Correcting Independent Third-Party Misinformation About Prescription Drugs. June 2014.
Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. June 2014.
Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices. June 2014.
Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. January 2014.
Guidance for Industry Direct-to-Consumer Television Advertisements—FDAAA DTC Television Ad Pre-Dissemination Review Program. March 2012.
Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. December 2011.
Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications. July 2011.
Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. December 2009.
Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved new Uses of Approved Drugs and Approved or Cleared Medical Devices. January 2009.
Guidance for Industry Patient-Reported Outcome Measures: use in Medical Product Development to Support Labeling Claims. December 2009.
Guidance for Industry: “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms. January 2004.
Guidance for Industry: Industry-Supported Scientific and Educational Activities. November 1997.
Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs). December 1997.
Food and Drug Administration Modernization Act (FDAMA) 1997. Sec. 114. Healthcare Economic Information.
Special thanks to Linda Pollitz and Stella Li for their input into the content and editing of this article.