Slide Notes From CCC Presentation At Zinc Forum - PRT Efficiency - Turbo-Charging Commercial and Compliance Effectiveness - Sept 2013

1. www.CommunicationCompliance.com
SLIDE NOTES FROM:
CCC Presentation at Zinc Forum: PRT
Efficiency - Turbo-Charging Commercial
and Compliance Effectiveness (Sept
2013)
Slide 1
When Zinc invited me to share trends and insights related to regulatory compliance, I
jumped at the opportunity to deliver the following message: a highly efficient
Promotional Review Process can quickly, easily and cost-effectively lead companies to a
pot of gold.
Slide 2
I can make this statement with confidence based on three 2010 quantitative surveys; two
2013 podium presentations; more than 5000 certification test scores; and input from
industry experts and analysis of warning letters and CIAs.
Slide 3
My plan is to take you through 3 key deliverables made by possible by PRT efficiency
that leads to this pot of gold, specifically your ability to:
1) Reduce waste
2) Prove that you drive the business with hard metrics, and perhaps one of the most
important deliverables of all
3) Help to align stakeholders in multiple channels to improve productivity and
professional satisfaction
Slide 4
I will also assert that the PRT creates a healthy tension between the compliance functions
and Commercial. Company leaders want to create an environment that protects and
grows the business. To accomplish this, there needs to be alignment between
Commercial and the compliance functions – regulatory, legal and compliance.
Alignment creates a healthy tension where risk is reduced (compliance effectiveness) and
sales are increased (commercial effectiveness).
This serves patients and improves overall public health.

2. Slide 5
There are many external forces driving the need for PRT efficiency. This presentation
puts a microscope on internal forces. These include rewrites of non-compliant materials
submitted by promotional agencies and Marketing; schism between commercial and
compliance functions; and the fact that compliance is not considered “relevant” to the
business.
No company can control external market forces. But companies can address any internal
forces that can make an organization vulnerable.
Slide 6
Let’s start with the legal and regulatory ramifications of non-compliant material.
Traditional FDA marketing enforcement
FDA will continue to pursue enforcement actions against marketing materials, and the
increase in staff at OPDP makes this easier. FDCA revisions broaden FDA authority so it
has the power to impose fines in a wider range of cases. And FDA staff is effectively
using the “Bad Ad” campaign to encourage healthcare professionals to report potential
advertising/marketing violations to OPDP.
Federal and state enforcement: false claims and anti-kickback statutes
There are 200 whistleblower cases that haven’t yet been opened by the DOJ so we can
expect multi-billion dollar CIAs and Deferred Prosecution Agreements to be announced
over the next several years.
State marketing enforcement under false claims acts
Many states use their own false claims statutes to bring suits, often using FDA Warning
Letters to demonstrate that marketing materials are false and/or misleading.
Private and class action “failure to warn” allegations for marketing activities
Product liability lawsuits continue to be filed against drug and device companies, alleging
that misleading and insufficient company communications can be held “responsible” for
causing injuries.
Slide 7
The risks surrounding the use of non-compliant material are evolving more quickly than
ever with greater ramifications.
Responsible Corporate Officer (RCO) liability
FDA signaled its willingness to hold RCOs accountable for regulatory compliance
through increased use of prosecutions. This is in response to Congressional queries and
continued industry violations. With RCO liability, corporate presidents and CEOs can be
convicted and potentially sentenced to a term of imprisonment without having directly
participated in – or even known about – a violation. They can be found guilty simply by
virtue of their position in the corporation and their responsibility and authority to prevent

3. or address the criminal violation. Some experts believe that marketing managers, sales
directors, and others in “responsible relationships” may also be held legally responsible
for violations.
OIG/FDA Collaboration
FDA and officials from the Office of Inspector General (OIG) in Health and Human
Services are actively cooperating and having ongoing discussions regarding their
concerns about off-label promotion. Warning Letters can tip off state regulators who
then investigate further.
Slide 8
And new risks continue to emerge:
The Medicare Modernization Act added drugs to Medicare through Part D, making the
government the biggest payer of prescriptions. This intensifies government scrutiny of
fraud and brings into play the False Claims Act.
The FDA Amendments Act of 2007 (FDAAA) empowered FDA to require a Risk
Evaluation and Mitigation Strategy (REMS) for certain drugs which, in essence, provides
FDA with additional oversight of drug marketing programs.
The Affordable Care Act includes a “stimulus bill” to fund studies on “comparative
effectiveness” (CE). This raises the bar for product differentiation, with an impact on
managed market acceptance.
Slide 9
Let’s move to the internal forces.
Slide 10
Benchmark data show that rewriting non-compliant materials has a high cost: it hampers
compliance and commercial effectiveness, which can quickly result in the loss of $2M
annually (or more) for every ten brands a company markets
Moreover, when teams are not on the same baseline of regulatory knowledge,
collaboration becomes challenging.
A company’s investments in compliance oversight and promotional review rigor can
easily drain away because of regulatory compliance knowledge and process gaps. This
hidden vulnerability reduces profitability and hampers business growth.
Slide 11
Data show that promotional regulatory professionals lose as much as 40 hours per month
rewriting noncompliant promotional materials submitted by vendors without proven

4. acumen in regulatory compliance fundamentals.
This is more than 25% of a regulatory professional’s time.
These data do not include time lost to rewrites experienced by a company’s legal,
medical or marketing functions.
In practical terms, that means a company with 15 people combined working in these
functions – as is common for mid and large-size companies – those rewrites can result in
more than $1 million dollars in waste annually.
Slide 12
On top of that, calculations show that agency vendors executing promotional campaigns
lose between $100,000 and $150,000 dollars per brand per year rewriting their own
promotional materials deemed as noncompliant by the client.
Most large brands work with multiple agencies such as advertising, public relations, and
digital, so these figures can quickly add up to another $1MM dollars in wasted time
annually.
Again, keep in mind that these figures don’t factor in the regular fees billed by agencies
for developing the original materials they thought were compliant.
Slide 13
This waste is no surprise.
The data show that marketing and agency professionals at every level (even senior
executives) are incorrectly answering basic regulatory test questions. This clearly shows
knowledge gaps on such fundamental issues as risk communication, reminder and disease
state awareness ads, and consulting agreements with spokespeople, among other topics.
In addition, when asked, marketing teams and their agencies often disagree with
Regulatory on how to implement key initiatives within compliance, which leads to more
waste. Disputed topics include digital initiatives, public relations tactics (media tours,
releases), promotional education tactics (speaker’s bureaus, slide kits) and ad boards.
Slide 14
Compounding the fact that regulatory knowledge gaps exist, the PRT is not always
involved in very early discussions on proposed strategies and tactics proposed by
marketing professionals and their agencies.
As a result, the agency begins to develop campaigns – without any opportunity to filter
out non-negotiable, non-compliance elements prior to submission to the promotional
review team.
The PRT must then redline the materials, which are then rewritten by the agencies -- at a

5. cost to the company. Ultimately, the review process is longer than necessary, which
means that marketing’s efforts are slowed down.
Slide 15
Companies are also identifying internal vulnerabilities related to the promotional review
process.
Experts say that there are over one dozen review parameters that need to be considered
when determining whether a promotional piece is compliant. What’s more, there are as
many as 200 queries associated with these review parameters that could be considered
during the review of a core campaign.
Review comprehensiveness and efficiency can be derailed by individual levels of
experience/expertise or reviews executed by new hires not yet trained in the company’s
compliance policies.
Additionally, when there are specific disagreements about a promotional piece, dispute
resolution may not be efficient and resources can be spent on points of relative agreement
while ignoring points of maximum disagreement. Companies traditionally conduct their
in-person reviews by going line by line to discuss every comment. Reviewers also spent
time looking for government documents to prove to marketing that their assessment of
the situation is in compliance with the law.
Also, since Legal, Medical and Regulatory collaborate on the review process, there is
often duplication and redundancy of comments, which can waste time and money. It’s
important that reviewers “swim in their functional lanes.” However, at the same time,
companies don’t want to stifle collaboration, which can lead to enhanced decision-
making.
If a company is under a CIA, these factors can potentially compromise compliance.
Slide 16
And speaking of silos, in a survey fielded at a major industry conference attended by
lawyers, regulatory professionals and compliance officers, participants were asked to
rank five strategies in order of their impact on helping a company sustain a competitive
advantage in a compliant culture. Alignment between regulatory professionals and their
marketing communications colleagues were ranked as the most important next to
leadership and commitment by senior management.
The next slide will provide barriers to delivering on this strategy.
Slide 17
These are some myths and misconceptions affecting collaboration
Slide 18
When stakeholders are not on the same page, unnecessary rewrites increase in number
and review cycles can take longer.
Furthermore, when the disparate functions don’t appreciate on another’s expertise, there

6. can be inter-departmental conflict and reduced morale. In some cases, this can reduce job
satisfaction and increase turnover.
As a result, companies experience a negative impact on Commercial and Compliance
effectiveness. It is more costly to develop fewer selling materials with optimized claims,
and the process is more inefficient with increased risk and fewer optimized claims.
Slide 19
The PRT can prove its value to the Business with metrics. Here are two examples of how
the PRT can measure the impact of its efficiencies.
These metrics are possible with new educational programs and testing systems that help
promotional agencies and marketing teams to get on the same regulatory knowledge
baseline. New web-based “screeners” now enable the commercial teams and agency
partners pre-review materials before they are submitted for promotional review. There
are also new training tools and algorithms to increase efficiency of the internal review
process without compromising review comprehensiveness. Finally, new key
performance indicators are available to measure the impact of these interventions.
Slide 20
PRT can achieve these metrics in large part by reducing the number of non-compliant
materials entering the system. The new PRT efficiency tools filter out non-negotiable,
non-compliant elements before submission, which reduces rewrites leading to faster
output of promotion.
Slide 21
It’s important to establish benchmarks before implementing programs so that impact can
be measured.
There are tools and programs to make this happen. These range from the new key
performance indicators (KPIs) that measure whether stakeholders are on the same
baseline of regulatory knowledge, to educational systems that help marketing and
agencies to filter out non-negotiable, non-compliant materials before submitting them for
internal promotional review.
The Drug Information Association (DIA) in alliance with the Healthcare
Businesswomen’s Association (HBA) has launched a new business acumen tool for
regulatory, legal and medical functions. New training and promotional review algorithms
are available as well for the regulatory, legal, medical and compliance functions.
New collaboration tools are also available to enhance collaboration.
Slide 22
Effective collaboration between all stakeholders is crucial.
Companies are wisely investing in infrastructure, technology platforms and processes that
avoiding creating silos. And of course, leadership development is key for strategic

7. thinking, listening, coaching, cross functional knowledge, and other softer skills that
enhance collaboration.
However, one barrier to collaboration still remains unaddressed: the human factor where
emotions enter the business realm. In order to create enduring cultural change, we need
to address the root cause for collaboration challenges and this is how we think about one
another.
Professionals in diverse functions who competently perform highly specialized and
skilled jobs have distinct approaches to accomplishing their goals, which can affect how
they interact. Unproductive interactions have the potential to create an exponentially
negative cascading effect on outcomes, including but not limited to reduced idea
generation and tunnel vision.
New tools are now available to help teams move from emotion-focused problem solving
to solution-focused problem solving.
The path forward requires a change in behaviors and attitude in order to successfully
affect behaviors and cultures across functional boundaries to match the business
objectives - Deloitte report
Slide 23
So combine an efficient promotional review process with collaboration excellence and
companies can create an integrity mindset. This mindset puts patients first, ensures
mutual respect and engenders company pride.
In terms of putting patients first, companies that experience fewer rewrites and shorter
review cycles are more efficient without affecting review comprehensiveness. This
results in more informative, fairly balanced materials in patients’ hands.
In terms of mutual respect, when knowledge gaps are closed and everyone is on the same
baseline of knowledge, diverse functions understand one another so there is less inter-
departmental conflict and morale is enhanced. This results in improved team building,
more job satisfaction and reduced turnover.
In terms of pride, embracing a culture of compliance leads to fewer violations and less
waste from rewrites. This money can be invested in innovation and education.
Ultimately this enhances the company’s reputation.
Slide 24
As you can see, this presentation made the case for how a highly efficient Promotional
Review Process can quickly, easily and cost-effectively lead their companies to a pot of
gold.
Slide 25
And then the PRT becomes a best friend forever (BFF).
LYS: I’m not sure about the BBF. Perhaps “becomes an ally on the journey to success.”
or something like that…