TIPPA News
The International Publication Planning
Association Newsletter
Volume 1, Issue III
Inside TIPPA News
Off-Label Dissemination: Where Does the Washington Legal Foundation Case Leave Us?
Exploring the New Frontier of Open Access Publishing
Measuring Your Success--The Role of Program Metrics
The 4th Annual Publication Planning and Execution Conference
In conjunction with Pharmaceutical Education
Associates, TIPPA’s annual conference took place June 5th and 6th
in San Diego. With the support of a faculty comprising leading industry
experts, the program examined the latest opportunities and challenges faced
by medical publications and communications professionals. This newsletter
provides a summary of just a few of the topics covered at the event.
The sessions encouraged lively discussions about the challenges facing the
industry, such as amplified legal and regulatory demands, polarization
across vocations, negative public perception driven by the press, and the
increasingly difficult task of navigating the journal approval process.
However, the event also provided a welcome reminder of the critical role
publication planning plays in the industry, and that its success depends on
the support of dedicated professionals focused on uniting the industry to
deliver timely and effective communications.
We thank everyone for their support of the event and look forward to
providing you with additional educational resources!
For those who weren’t able to join us in San Diego, here’s the latest on the Association and its upcoming initiatives. TIPPA will be initiating a number of exciting projects in the near future, such as:
Ø Comprehensive educational tools, including Web-based seminars
Ø Expanded content on the association’s Website
Ø Regular newsletters addressing the latest industry topics
Ø Recruitment of additional advisory board members
Ø More opportunities for networking and idea exchange among members.
Over 500 members strong and continually
attracting top professionals in the medical publishing community, TIPPA
looks forward to providing the industry with a forum to collaborate on best
practices, exchange recommendations and form ethical guidance.
If you haven’t had a chance to complete the member survey, please
click here. A demographic summary of the survey will be distributed to members.
Off-Label Dissemination: Where Does the Washington Legal Foundation Case Leave Us?
As noted in a presentation by an in-house
attorney, it is estimated that over 50% of prescriptions are off-label. For
the publication planning industry, this presents a quandary. Despite support
from the Washington Legal Foundation Case’s victory, the constitutionality
of parts of the FDA Modernization Act (FDAMA) remains unresolved, leaving
many questions unanswered on how to disseminate scientific product
information on off-label products.
Because there is no resolution on which part of
the injunction still stands, there are no assurances that what you do will
survive legal scrutiny unless you follow all of the FDAMA provisions which
will give you "safe harbor." In light of this, the presentation provided
general guidelines for publications professionals, including the following:
Providing Off-Label Information is Permitted if:
The information provided on unapproved uses for prescription drugs is:
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distributed to: Health Care Professionals, Pharmacy Benefits Managers, Insurers, Group Health Plans, Federal or State Agencies. |
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for educational purposes or based on an unsolicited request. |
Safe Harbor Requirements for Dissemination of Information on Off-Label Use:
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Drug discussed is approved for (any) indication. |
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Information disseminated meets certain requirements. |
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Information includes appropriate disclosures. |
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Information includes bibliography of other published journal articles or reference publications about the unapproved use. |
For Safe Harbor to Apply, the Manufacturer Must:
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submit a supplemental application for the off-label use. |
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or certify an intention to do so |
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unless: |
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supplemental application is prohibitively expensive. |
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or it is determined unethical to conduct the necessary studies. |
Requirements for Information Disseminated:
The information must:
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either be a journal article or reference publication. |
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be unabridged and retain the same appearance, form, format, content, and configuration as the original article. However, it may discuss a reference publication in accompanying explanatory information. |
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be "scientifically sound," and this does not include: |
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letters to the editor |
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abstracts |
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reports of Phase I trials in healthy patients |
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reference publications that contain little or no substantive discussion of relevant clinical investigation |
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a study of four or fewer people, unless it could help guide a physician in medical practice. |
The information can’t:
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be false or misleading and must avoid: |
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presenting conclusions not supported by study results. |
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including only favorable publications when unfavorable publications exist. |
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pose a significant risk to public health. |
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be based on another manufacturer’s research |
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unless used with manufacturer’s permission. |
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Important Note: This is just a very brief and cursory summary of operating under FDAMA’s safe harbor. Manufacturers are strongly recommended to include legal counsel in the process to help ensure compliance.
Exploring the New Frontier of Open Access Publishing
The traditional journal publishing model is
alive and well; however, achieving publication in a biomedical journal has
evolved into an increasingly difficult and complex process. In a
presentation on open access publishing, attendees explored the evolution of
this model and how to incorporate it into their planning strategy.
Presentations by WebMD and BioMed Central
reviewed the numerous benefits of the open access model. From the
authors/researchers perspective, open access offers greater distribution, as
these articles tend to offer more full-text accesses and PDF downloads than
their subscription–accessed counterparts. Besides allowing the authors to
retain the copyright, other benefits can include greater chances of being
published and a speedier submission process. But the benefits extend beyond
the biopharmaceutical community. For example, this model can make research
articles freely accessible via the Internet without subscription barriers or
standard journal costs.
While the open access model clearly offers
benefits over traditional journal publishing, the final verdict remains out
on whether one of these models will dominate in the future. When deciding
which publishing model to pursue for your next publication, taking time to
review the pros and cons of each will help you make the right decision. For
example, as pointed out in a later presentation on balanced communications,
consideration must be given to the final audience. With most physicians
spending four hours or less a week reading literature and a wide range of
factors influencing their interpretation of an article, it appears that the
industry will rely on both publishing models for several years.
Measuring Your Success-The Role of Program Metrics
Publication professionals face significant
external pressures that range from legal exposure to the journal review
process. While this statement may hold true for most publication
professionals, a pre-conference workshop lead by Envision Pharma and Roche
Laboratories recognized that internal demands─primarily the pressure to
provide meaningful measurement of the value of the work they do─can be just
as challenging. Tasked with improving the efficiency and effectiveness of
their processes in a highly competitive environment, publication
professionals must validate not only the existence of the publications’
planning role within their organization, but also the value of the overall
program to the product it supports.
The workshop leaders first explored the need for
metrics by reviewing the current environment pharmaceutical companies
operate in, as well as offering the insightful reminder that:
The two most important elements of a successful
pharmaceutical product are:
Ø the clinical trial program
Ø the development and dissemination of data generated by the program
With the need for metrics established,
discussions moved to identifying metrics opportunities and how to categorize
them. Attendees learned about how to categorize opportunities into four
subsets─quantitative, qualitative, usage (systems), and financial and
productivity─with examples provided for each category.
Discussions then focused on how to establish a
metrics mindset and gather data by implementing a seven-step approach. This
approach, which begins with defining a statement to focus your intentions
and ends with modifying your processes for improved effectiveness and
efficiency, provides a methodical guide for establishing metrics in a
company. However, while implementing a methodical approach is critical to a
successful publication metrics program, other factors can affect your
success. These intangibles, ranging from external environmental factors to
corporate culture, all need to be factored in when establishing any program.
After a morning of interactive exchanges and
group breakouts, the workshop provided attendees with deliberate action
items and reminders to take with them. Within their concluding message,
discussion leaders reminded attendees that metrics should be used
judiciously and treated as a tool rather than a solution.
About TIPPA: The International Publication Planning Association
The International Publication Planning
Association (TIPPA) is an industry-run association. Our mission is to foster
excellence in medical publications and communications within the
biopharmaceutical industry by providing a foundation from which industry can
stand together to organize thoughts, present recommendations and ethical
guidance. In addition TIPPA provides practical strategies for developing,
implementing and executing an effective publication and communication plan
as a critical component of the clinical biopharmaceutical development
process. Our aim is to help biopharmaceutical communication executives and
their agencies produce ethical and targeted publications and clinical data
throughout the product lifecycle.
To contact TIPPA, email
hmurrin@pharmedassociates.com, or
visit us at
www.publicationplanningassociation.org.
If you have a colleague who is interesting in joining TIPPA and receiving TIPPA’s Newsletter, please send them the TIPPA membership application or email hmurrin@pharmedassociates.com!
Call for Papers!
If you have an article you’d like to see
published on the TIPPA website, please submit it for review to
hmurrin@pharmedassociates.com.
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6/28/06 Streamlining Your MAPD and PDP Programs for Success in this Competitive Marketplace |
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7/17/06 Innovations in Partnerships, Product Features, and Integration |
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7/24/06 Navigating the Complex European Supply Chain More Efficiently and Effective. |
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7/31/06 Reaching and serving the low-income and dual eligible market. |
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9/11/06 Adapt to the Opportunities and Challenges in the Rapidly Evolving Healthcare Payment Landscape & Optimize Your Consumer Payments and CDH Market Share. |
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9/18/06 Innovative Methods and Applications for Risk Assessment in Pharmaceutical Development |
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2nd Annual Ophthalmic Drug Development and Delivery Summit
9/19/06 Two days packed with specific, cutting-edge science; insightful overviews; and networking opportunities |
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9/20/06 A practical guide to managing risks and meeting business objectives. |
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10/10/06 Advances in Nasal, Pulmonary, and Inhaled Delivery Systems |
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For more information on these events, call 1-800-686-2276 or go to
www.publicationplanningassociation.org.
TIPPA
343 Soquel Ave., Suite 334
Santa Cruz, CA 95062