day late, and a dollar short – this idiom
sums up the position many life sciences
companies today are in when it comes to
producing and managing promotional
content in a compliant manner. Current
approaches, such as using a paper-based “brand book” or
core claims guide, can’t keep pace with the digital realities
facing regulatory departments.
For starters, the volume of promotional content is exploding – pharmaceutical companies spent $4.5 billion on
marketing prescription drugs in 2014, up from $3.5 billion
in 2012. Further, FDA receives an average of 80,000 promotional material submissions a year! Combine this volume with the growing number and complexity of global
digital channels actively used to distribute promotions and
it’s clear that life sciences companies are overwhelmed and
exposed to an alarmingly large risk of error along with all
of the associated regulatory and business consequences.
Patients add more to the mix by demanding a richer,
two-way dialogue with companies about the efficacy, heredity, and quality of their products. The easy availability
of medical information and ongoing conversation with
patients via social media channels put intense pressure
on companies to properly disseminate promotional content in a strategic, efficient, and compliant way.
At the same time, the cadence and interactivity of messaging has accelerated dramatically while the process of
creating, sharing, and approving vast quantities of content involves many stakeholders, often spread around the
world. The explosion in global marketing requires a far
greater focus on international brand alignment and the
need to improve cost efficiencies with smarter re-use of
marketing materials. All these pressures drive marketing
teams to develop campaigns in which assets are shared,
distributed, and re-purposed to global markets, each with
different regulatory requirements.
“When it comes to managing promotional content, it’s
a new world – demanding, fast-paced, and patient-fo-cused,” says Eric Newmark, program director, IDC Health
Insights. “Not only do life sciences companies have to
keep up with patient demands for clear, accurate product
information, they must also track the steady stream of developments in clinical research so promotional materials
remain current. Managing marketing content efficiently
has never been more challenging.”
Cumbersome paper-based processes
Life sciences companies that manage massive amounts of
promotional content via manual, paper-based processes
are inevitably saddled with widespread inefficiency. Medical, legal, and regulatory review, already a notoriously
time-consuming process, is even more cumbersome with
paper documents and highly vulnerable to human error.
Discrepancies can easily arise when brand teams in many
departments on several continents have different versions
of a promotional piece.
Research reveals how pervasive this problem is today.
The Pharma Letter has reported that over the past six years,
the number of warning letters issued by FDA for fraudulent
marketing practices grew by 78 percent. In addition, findings from the Veeva 2015 Life Sciences Promotional Content Management Survey, which looked at the impact of
changing from paper-based to digital content-management
processes, revealed startling levels of inefficiency from creation and review to expiration and withdrawal. More than
half (52 percent) of respondents in the study say they use
automated processes, but most report they’re missing some,
if not all, capabilities that are essential for compliance.
Most of the companies surveyed (88 percent) said their
content management function is scattered among many
systems and methods, suggesting serious break points in
existing processes that breed inefficiency. In fact, respondents said that, on average, they use four different systems
for promotional materials management with 31 percent
reporting to use between five and 20 systems. With so
many separate, disconnected systems, a letter from FDA
instructing a company to remove all claims from promotional materials for a given product can create severe delays. And, the price of non-compliance is high – according
to the U.S. Department of Justice, drug companies agreed
to pay $13 billion between 2009 and 2013 for fraudulent
marketing practices. Fines are just one price to pay. This
doesn’t include the costs for lost productivity, delays to
market, and damaged reputations.
Tracking down claims manually isn’t easy
Confronted by this type of warning, a company’s regulatory department faces the daunting task of quickly finding an improper claim amidst a vast assortment of promotional materials that includes brochures, sales aids,
advertisements, web site content, and more. The company must remove the claim and report to regulatory authorities that it has been deleted from the public domain.
In some cases, life sciences companies must halt promotional activities until the process is complete.
This task is much more onerous when a company’s assets
can’t be efficiently shared because of a paper-based materials management system. With paper, there is no inventory
listing every appearance of every claim across promotional
materials and therefore no easy way to identify all locations
of a specific claim to ensure that each mention is withdrawn
quickly. This dilemma is all too common. In fact, most respondents to Veeva’s 2015 survey (81 percent) are unable to
report specifically where claims and content are used. To locate and remove a single claim in that situation, a company
might have no choice but to pull an entire campaign, which
leads to lost promotion time as many multichannel assets
are stripped of usable, approved content. This task drains
valuable regulatory department resources, too, and slows
the review and approval of other promotional materials
that aren’t affected by the regulatory warning. According to
data compiled from Veeva clients, life sciences companies
reduce the potential productivity of their review team by 25
percent due to unnecessary rework.
Regulatory isn’t the only group affected. The medical
team must vet replacement claims for accuracy; the legal
staff needs to decide on the proper corrective action; and
operations must orchestrate the complicated withdrawal
and re-approval process.
“Life sciences companies need better capability to
rectify errors quickly, in real time, before incorrect data
is used in sales, marketing, or medical outreach to customers,” Newmark says. “When time is of the essence,
helping departments save time by collaborating simultaneously becomes vital.”
It’s time to take claims management into the
Time is up – being a day late, unfortunately, is much worse
than just being a dollar short in the modern world. A single
promotional materials management solution with life sci-ences-specific functionality for creation and approval, plus
an accessible reference and claims library, integrated review
and approval workflow, complete audit trail, and easy distribution mechanism that’s built around an enterprise digital asset management system brings everything needed for
With an end-to-end solution, companies can quickly
search for a claim across assets anywhere in the global digi-
tal supply chain so local affiliates can deploy global promo-
tional programs and still comply with regulatory standards.
This doesn’t come as a shock to the industry. Almost half
(49 percent) of the respondents to the Veeva study conceded
that while they don’t have primary systems that provide an
end-to-end audit trail, having that capability would improve
compliance. Yet, with an end-to-end system, outdated ma-
terials or claims can be pulled, revised, and redistributed
quickly – mitigating the risk of noncompliance and saving
both marketing and regulatory teams the chore of manually
searching for every instance of a claim or asset. Overhead
costs for the review, rework, and distribution of materials
plummet. Indeed, even marginal cost savings across the
many stages of the digital supply chain can result in signif-
icant savings. Likewise, a digital system frees up regulatory
department resources by streamlining approval, re-use, and
distribution of materials to global company sites.
It also allows real-time collaboration for faster content
development and fewer iterations of an asset as it circulates through review and approval cycles, which ultimately, brings promotional materials to market faster. Content
reuse is possible too. In this digital world, repurposing
content brings dramatic time and cost savings, plus it
helps ensure consistent messaging whether a communication is sent via email from a sales rep, through a digital
detail online, or in an advertisement.
Maybe most significantly, an end-to-end promotional
materials management system with digitized claims can
help solve a persistent, costly problem for regulatory de-
partments − replacing claims that become outdated as
new scientific data or regulatory requirements emerge.
“Because so much research is being conducted and vital
new discoveries occur regularly, an important finding
from a clinical trial might be outdated in a short time,”
Newmark says. “A digital content management system
that allows claims to be updated in real time across mul-
tiple promotional materials ensures that stakeholders al-
ways see the latest, most accurate information. This isn’t
possible with a paper-based system that doesn’t have a
fast, easy way to amend or remove claims.”
According to the Veeva study, 100 percent of companies
using digital, end-to-end content management systems are
satisfied with their ability to adhere to regulatory standards
across channels and 88 percent are satisfied with their abili-
ty to electronically withdraw outdated content.
In the life sciences industry, there is a lot riding on this
issue. Old approaches to managing promotional claims
are inefficient at best, risky at worst. The cost of failing to
efficiently, accurately manage claims is high – not only
from stiff fines but also from commercialization delays.
Additionally, life sciences companies are now racing the
clock. FDA is requiring that promotional materials be submitted via the Electronic Submissions Gateway beginning
May 2017. Companies using paper-based claims inventories face the immense task of transferring their records
to the digital, standardized submission forms required by
FDA. A next-generation technology with digital claims
management across the supply chain would make preparing FDA submissions easier and faster.
“To improve current approaches to promotional claims
management, automation and the streamlining of manual processes will be necessary, along with potential
organizational changes.” Newmark says. “Regulatory,
marketing, and sales teams all need to work together to
optimize their current claims management practices …
not just for business purposes, but to also ensure they are
eliminating any potential risk from a regulatory compliance standpoint.” medadnews
James Brown is VP and general manager of commercial
content at Veeva Systems.
Claims management in the digital age