As the great Yogi Berra once said, “The future ain't what it
used to be…” That is especially true when looking at the multitude of changes
facing the biopharmaceutical and medical device industries. What will 2008
bring in terms of how we communicate with our customers and patients? And what
are some of the greatest challenges we face?
A group of BioPharma marketing leaders was recently asked
what their greatest regulatory challenge is. Their answers to that question
were summarized as follows:
Understanding the new guidelines/codes/regulations and the implication to their
Distinguishing between guidelines/codes/regulations/standards
Implementing company policy relating to those guidelines/codes/regulations
the relationship between legal, regulatory, and individual functions
clients and vendor partners to understand how the changes affect the business
relationship and outcomes
Further discussion centered on the various organizations
that have impact on marketing and communication practices within the healthcare
environment. The major groups are the obvious players: the FDA, OIG, ACCME, AMA
and PhRMA/BIO/AdvaMed. When discussing corporate policies related to these
organizations, marketers are still confused about “who rules,” both internally
As we look into 2008 there are three areas of concern that
members of the industry need to address. These include:
1. The FDA Amendments Act (FDAAA) of 2007
—The Prescription Drug User Fee Act (PDUFA)
—The Medical Device User Fee and Modernization Act (MDUFMA)
2. Senate Finance Committee Report on CME
3. ACCME Policy Updates
1. The FDA Amendments Act (FDAAA) of 2007
PDUFA and MDUFMA were reauthorized and expanded to take
effect January 1, 2008. The new act enhances the FDA's authority to regulate
marketed drugs, and the amendment is considered to be the most comprehensive
reform by the FDA in decades. Patient safety is of the primary concern of the
agency and the changes within the amendment reflect that concern. Key
components of the FDAAA:
PDUFA—allows FDA to collect fees from pharma companies to help fund reviews of
new drugs. The act enables shorter review times and a more predictable review
process, while still maintaining high-quality reviews.
MDUFMA—allows for user fees, and will allow FDA to make significant
improvements in the medical device review program.
Pharmaceuticals for Children Act (BPCA)—encourages more studies in children and
promotes the development of treatments for children.
Research Equity Act (PREA)—continues FDA's authority to require studies in
children concerning certain medical products and under other specific
Among other things, the law also provides for:
Additional encouragement of specialized pediatric medical device development.
creation of a foundation (Reagan-Udall) to modernize product development,
accelerate innovation, and enhance product safety.
Provisions intended to enhance drug safety
The amendments authorize a new program for the collection of
user fees to support FDA review of TV ads directed at consumers.
The impact upon the industry includes the following:
Increased pediatric research
Additional restrictions on labeling
Post-approval surveillance studies
Risk evaluation and mitigation plans
In assessing these changes, the results will include
increased costs of drug development, in part due to the requirement for
post-approval plans, surveillance studies, pharmaco-vigilance, risk evaluation
and mitigation. There will be longer development time, more stringent
regulatory reviews and a constrained ability to make marketing claims as a
result of more restrictive labeling and tighter regulation of promotion and DTC
So what does this mean for specific healthcare entities?
Compliance obviously rules as the FDA regulates our industry. At a minimum, the
individual products to the lot and serial number
Post-approval surveillance plans identified and implemented
self-inspection, accountability and focus on safety
discussions with the FDA on risk management plans and programs
studies to be posted on a website registry
for generic drug adverse events to be established
Finance Committee Report on CME
The authors of this document are Senators Max Baucus,
chairman, and Charles Grassley, ranking member of the committee.
Why did the Senate Finance Committee decide to review the
use of educational grants from the BioPharma and medical device industries?
There are several possible reasons:
n The US
Committee on Finance has exclusive jurisdiction over Medicare and Medicaid with
80 million Americans and a 2006 expenditure of over $700 billion.
committee is responsible to ensure program funds are spent properly (including
prescription drug benefits).
marketing and utilization became a concern to the committee.
committee became aware that Pharma et al funds education programs to “help
build market share.”
In addition, the committee articulated two primary concerns:
products tend to be more expensive than older/generic products which raises the
costs of CMS expenditures.
products have less clinical history than older products which raises the
concern of safety.
In June 2005, the committee wrote to 23 of the largest pharma
companies to inquire about the use of educational grants. Pharma referred them
to the ACCME. The committee also reviewed medical literature and information in
The findings of the committee, released in 2007, identified:
uses education to increase the market for their products”
regarding off-label use (increasing drug utilization resulting in increased CMS
have taken steps to separate independent grant process funding
groups have guidelines to reduce the potential for influence of content
guidelines (ACCME) reveal inadequacies in monitoring/enforcing independence
from commercial influence (ergo, opportunity for fraud and abuse)
Because these areas concern the Senate Finance Committee, it
concerns the industry and those involved in medical education. There are some
important steps that can be taken by companies involved in medical education
(both client and service providers) to mitigate risk while still ensuring the
delivery of quality, independent education programs:
the education functions from marketing and especially sales. This was initially
stated by the OIG in 2003.
an objective grant approval process. Many BioPharma companies have moved to
online grant submissions with blind reviews by committees independent of the
sales and marketing organizations.
a “hands-off” approach with CME
companies are moving funds formerly dedicated to CME to activities perceived as
internal compliance programs
Compliance departments with resulting programs and policies
are becoming core functions within the BioPharma industry. That being said,
Kenneth Berkowitz, Esq. has been quoted as saying: “It's not just having a
compliance plan; it's having a plan that's living, breathing, and working. Just
don't have this great document; it has to be implemented.” Elements for an
effective compliance program include:
Designating a compliance office and committee/department
Implementing written policies and procedures
Conducting education and training
Developing effective lines of communication
Performing internal monitoring and audits
policies through well-published disciplinary guidelines
Responding promptly to identified problems and undertaking corrective action.
3. Accreditation Council for Continuing Medical Education
(ACCME) Policy Updates
The ACCME is the organization that identifies, develops and
promotes standards for physician education. They accredit for-profit and
not-for-profit institutions and organizations that offer continuing medical
education (example, medical education companies, hospitals, professional
societies, etc). The ACCME evaluates these CME providers and ensures compliance
with ACCME standards.
The Standards for Commercial Support are written for CME
providers to ensure the independence of CME activities. They had previously
been updated in 2004 and 2006. There is a general belief within the CME
enterprise that the 2007 updates occurred as a result of :
became interested in education in 2003 and issued their OIG Compliance Guidance
for Pharmaceutical Manufacturers
n In 2005 the
Senate Finance Committee became interested in education because of the
potential for fraud and abuse, inducement to prescribe, off-label discussions,
and increased drug expenditures (see previous section)
committee queried the ACCME regarding its role in monitoring independence in
certified CME programs
committee issued its findings in 2007, Use of Educational Grants by
Pharmaceutical Manufacturers, one of which revealed inadequacies in
monitoring/enforcing independence from commercial influence
n In 2006,
drug manufacturers funded over $1.9 billion into CME.
Following the Senate Finance Committee report, the ACCME
issued another revision of The Standards for Commercial Support in August of
2007. Major areas of concern to grantors as well as providers include:
commercial supporter cannot specify the manner in which a program will be
developed. Example, a commercial supporter cannot recommend speakers or review
content. Review of content is a concern to the BioPharma industry, specifically
as it relates to product data and the accuracy of reporting such data. While
grantors have understood that they cannot control content of a certified CME
activity, in the past they have been able to review content for accuracy if
requested by the provider. Again, this change becomes especially critical when
there is new product data being presented and the grantor/BioPharma company may
have the best resources for scientific review.
Definition of commercial interest: “A ‘commercial interest' is any entity
producing, marketing, re-selling, or distributing healthcare goods or services
consumed by, or used on, patients.” No entity owned or controlled by a
“commercial interest” can be accredited by the ACCME system, and there are no
structural or organizational “firewalls” that could be put in place for a
company that is owned or controlled by a “commercial interest” to suffice for
n The major
change in the definition is the addition of the word “marketing,” implying the
restructuring of med ed companies to ensure separation from parent companies
such as advertising agencies. This means, for example, that accredited medical
education companies cannot remain as wholly-owned subsidiaries of an
advertising firm. The change reflects the overwhelming concern of the ACCME to
ensure independence of certified CME. However, while attempting to exclude
medical education and communication companies, the ACCME continues to exempt
other types of commercial supporters such as for- and not-for-profit hospitals,
health insurance providers and others from the commercial supporter definition,
in effect, promoting a two-tiered system.
of interest continues to remain a hot-button for CME providers. Anyone who is
in a position to control content must disclose their “relevant” financial
relationships within the past 12 months that could create a conflict of
interest. From the speaker perspective, this includes relationships with BioPharma
including participation in clinical trials, serving in an advisory capacity, as
a spokesperson, author, stockholder, etc. ACCME considers financial
relationships to create a conflict of interest which could result in content
bias. It is the provider's responsibility to resolve conflict of interest with
How will the industry respond to these changes in certified CME?
BioPharma must not exert any influence over the grant-making process and
provisions of certified CME. This has become very clear. Internal decisions
regarding a company's involvement in education will evolve over time, with
considerations including the cost-benefit of funding certified CME. Some
companies are already allocating their funds to other forms of education,
including on-label, promotional programs. Other companies are directing their
funds to professional organizations, schools of medicine, and education
foundations. And some companies are choosing not to fund certified CME. The
message is clear that certified education must remain independent of commercial
influence. Ongoing dialogue with stakeholders is critical to ensure the
independence, accuracy and value of CME for physicians and their patients.
“The future ain't what it used to be.” This year will bring
many challenges to companies including their response to these regulatory and
other changes facing the BioPharma industry. What we know is that the industry
will respond accordingly, to ensure their mission of providing safe and
effective therapeutics for the improvement of patient care. And they will
communicate this information with the most effective means of reaching
healthcare providers, patients, and their caregivers.
Linda Klein is president & CEO of Klein & Company