Rethinking the Role of Regulatory in Innovation: Part 2


This is the second in a series of articles on the need to eliminate the misperception that regulatory, legal and compliance professionals are sales suppressors and policemen.   These functions and innovative thinking are not incongruous terms. If you have not yet read how these professionals can (and do) think outside of the proverbial box to support their business colleagues and achieve critical company objectives that help increase the top and bottom line, please click here.

In this article, industry veterans continue to share best practices on how regulatory professionals can be more innovative:

  1. Watch Your Tone
  2. Become More than a Stamp of Approval
  3. Do Your Homework and Be Proactive
  4. Be Open to Informal Conversations
  5. Stay on the Lookout for New Tools
  1. Watch Your Tone

Regarding tone, Mark Gaydos, Vice President & Head, US Specialty Care, North America & Global Regulatory Affairs, Sanofi explains that, “Every review member has a perspective that they are asked to bring to a risk/benefit discussion and when we share that perspective, we must adopt a collaborative, inquisitive, and non-aggressive tone.  Rather than communicating our perspective defensively, we can clearly explain our position, provide the underlying rationale, and explain risks associated with different approaches.”

In the same vein, marketers must take the time to explain their needs and goals without being defensive or patronizing. ” Teaching one another how to create an innovative environment is part of the solution,” claims Maria Finlay, Associate Director of Oncology Marketing at Teva.

  1. Become More Than a Stamp of Approval

According to Bruno Falcone, Healthcare Compliance Director, Global Compliance, Takeda, “Regulatory functions should not act merely as approvers and business people should expect much more than getting a regulatory stamp on what they do. Regulatory professionals need to be perceived as strategic advisors providing the tools that people need to make the right decisions particularly in strongly regulated, politically influenced and sensitive environments.”

  1. Do Your Homework and Be Proactive

Innovative regulatory professionals come to the table having done their research on the issues brought forward by commercial and proactively offer solutions.  They supplement what they don’t know by researching the topic and talking to others who may have more experience and perhaps have encountered a similar issue in the past.  Background research can include analysis of FDA guidance documents, medical reviewer comments, violation letters and advisory feedback from the Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (APLB).

“When regulatory professionals are fully knowledgeable about the key topics, they can effectively navigate the barriers and help formulate innovative solutions,” states Stacy Joseph-Reese, Director of Regulatory Promotional Review for Teva Pharmaceuticals, who shares an example where she helped the commercial team meet its business objective while saving time and resources on rework.

“When launching a new product, getting the promotional materials into the market quickly is a key priority.  Teams must consider the need for seeking FDA advisory comments on core materials, the implications of potential feedback and impact on timelines.   Researching FDA enforcement letters, previous advisory feedback and guidance documents can help drive this strategy or even provide clear and supportable regulatory direction when this path is not taken.  Providing specific examples and recommendations can help the team collaborate on thoughtful solutions.  For example, I have proposed revised content for a draft sales aid by creating a visual mock-up to help the team understand the proposed regulatory solutions and quickly reach final agreement.”

Iris Gibbs, Associate Director of Regulatory, Advertising and Promotions at Regeneron Pharmaceuticals, Inc. adds, “Careful monitoring of first amendment challenges and FDA warning and untitled letters allows our team to do a better job of gauging the risk/ benefit profile of potential commercial claims.  Companies have to assess their internal risk tolerance and then Regulatory partners can help craft innovative and creative messaging to meet that level of tolerance.”

  1. Be Open to Informal Conversations

Proactive regulatory professionals are open to informal conversations about potential ideas.

“Many companies are integrating concept reviews into the review cycle.  However, Marketing and Regulatory can interact even earlier to engage in informational discussions about core strategies and tactics.  These conversations can set expectations and frame up the innovative idea before a formal review takes place,” explains Joseph-Reese.

“There are real FTE resource and cost savings as well – concept review discussions offer an avenue to harness collective thinking to sharpen the tactic, address any potential issues, and ultimately increase speed to market,” adds Violet Aldaia, Global Client Leader at Omnicom.

Joseph-Reese says that “Too often marketers have spent time and money on an idea before the concept review.  With high level discussions, you can begin tactic development with your eyes open because the underlying strategies have been carefully evaluated and expectations have been set based on a shared understanding.  This prevents excessive back and forth because you can collaboratively work out issues before significant money is invested.”

Gaydos agrees, adding that when business colleagues stop by to ask whether a new idea is worth considering, these types of informal conversations help fuel innovation.  “Even if an idea as presented is not executable, the conversations plant new seeds for additional ideas and continued exploration of a path forward.”

“Regulatory professionals should step away from the computer, get out of the office, and start talking to business colleagues,” states Kathryn Stripling, Executive Director at Astra Zeneca.

“Oftentimes, we only meet with business colleagues when they are across the table during review team meetings.  Not surprisingly, many of us would rather communicate by email than have an informal discussion over coffee.  We should force ourselves to get out of our comfort zone.  Informal meetings help us build relationships, eliminate misperceptions about the ‘regulatory professional’ and provide opportunities to share perspectives, discuss ideas and strategy early, and find out what’s coming.

Once we have built relationships, it is more likely that business colleagues will see us as valued partners and feel more comfortable reaching out to us, and in turn, we will feel more informed and effective.  Everybody wins. “

  1. Stay on the Lookout for New Tools

Tracy Rockney, JD, Co-Founder & Managing Partner of OneSource Regulatory states, “Encourage your regulatory partners to take a page from their commercial counterparts and bring in external experts who can provide direct experiences with new technologies in pharma. Brand teams will see huge value if you bring them a new idea/medium already created with a successful regulatory pathway defined that makes it compliant.”

Innovative regulatory professionals are open to new tactics that may have been challenging to review and approve in the past. For example, mobile patient apps supporting pharma brands have been difficult to use due to issues of balance and disclosure, data privacy, Form FDA-2253 submission, and concerns about certain apps being regulated as “medical devices”. Indeed, there is an app graveyard filled with aborted app projects.

Yet, mobile apps that support safe use of medication and increase adherence can help patients achieve treatment goals in coordination with their physicians.  Health Insurance Portability and Accountability Act (HIPAA)-compliant platforms also provide superior customer insights through access to anonymized longitudinal data on the patient journey, and on patient and healthcare professional (HCP) engagement with the brand or company services and materials. This “real world” data can provide information on the safe use of medicine or reasons for premature discontinuation.

According to Dr. Peter Pitts, Chief Regulatory Office at Adherent Health and a former FDA Associate Commissioner, “Proper provision and accommodation for brand fair balance and disclosure is possible to achieve mobile app compliance, regardless of whether the app supports HCPs or patients.”