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RiskBenefit Implications for Pharmaceutical Marketing


How closely tied are the regulatory authorities to pharmaceutical companies? ... Do pharmaceutical companies spin safety information to their own ends? ... – PowerPoint PPT presentation

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Title: RiskBenefit Implications for Pharmaceutical Marketing

Risk/Benefit Implications for Pharmaceutical
PMCQ Education Day - Emerging Trends in
Pharmaceutical Marketing Montreal, October 20,
Topics Covered
  • Recent Regulatory Decisions re Safety
  • Response in the Regulatory Arenas
  • Public Response
  • Implications for Marketing
  • I would like to acknowledge IMS Canada and its
    publication, Provincial Reimbursement Advisor, in
    preparing this presentation.

Safety Letters Posted on Health Canada Website
Antidepressants and Suicide Potential
  • Late 2003 - Public concern about possibility of
    antidepressants and suicide potential.
  • February 2004 Scientific Advisory Panel held
  • Recommended stronger warnings
  • May 2004 SSRIs updated to warn re potential of
  • Class warning patients under the age of 16

  • Market withdrawal of VIOXX on September 30, 2004
  • December 2004 US Congressional Report
    criticized how Merck and the FDA had disseminated
    information related to safety of VIOXX.
  • June 2005 Canadian Expert Advisory Panel
    recommends that VIOXX be returned to the Canadian
    market with updated labelling.
  • July 2005 A US judge rules that a nationwide
    class action lawsuit could be brought by a labour
    union helaht plan on behalf of all 3rd party

  • July 2005 EU advises that compliance of VIOXX
    ADR reporting will be investigated.
  • August 2005 Merck loses first case re VIOXX and
    must pay 253 million to family in Texas.
  • September 2005 Ontario Superior Court hears
    arguments requesting class action be allowed.

Adderall XR
  • Feb 9, 2005 marketing of ADDERALL XR suspended
  • Based on sudden deaths (20) reported in PMS.
  • 14 in children
  • Aug 26, 2005 New Drug Committee Hearing held.
  • Product can be remarketed with changes to Product

Long-Acting Beta-2 Agonists
  • October 4, 2005 possible increased of
    asthma-related deaths
  • SMART study
  • Began in 1996 at request of FDA.
  • Study of approximately 30,000 patients was
    prematurely halted in January 2003
  • FDA advisory committee in July 2005

Questions Being Asked
  • How closely tied are the regulatory authorities
    to pharmaceutical companies?
  • How transparent are the decisions made by
    regulatory authorities?
  • How do pharmaceutical companies comply with
    disclosure regulations
  • Do pharmaceutical companies spin safety
    information to their own ends?
  • How much does the public have a right to know?
  • How much is really known about a drug when it is
    first marketed?

Controversy re safety
  • Unless the Canadian public can be assured that
    Health Canada is adequately monitoring the safety
    of marketed drugs, then confidence in the use of
    therapeutic products will suffer, and so will the
    health of Canadians.
  • Lexchin J. Drug withdrawals from the Canadian
    market for safety reasons, 1963-2004. Canadian
    Med Assoc J 2005172765-8.

Response in the Regulatory Arena
  • Canadian public want to know the basis on which
    decisions are made.
  • Provincial governments and other payers also want
    to know the basis on which these decisions are
  • To address these concerns, Health Canada has
    taken a number of recent steps to disclose how
    decisions are made.

Office of Public Ombudsman
  • April 16, 2005 Health Canada announced the
    creation of the Office of Public Ombudsman
  • Will receive complaints, concerns and feedback
    about how Health Canada fulfills its
  • To date no Ombudsman has been appointed.

Public Expert Advisory Committee Meetings
  • June 9, 2005 first public EAM held on COX-2
  • Any interested parties could attend and address
    the Panel.
  • Reort posted on Health Canadas website, together
    with all documentation given to Panel to consider
  • Sept 2005 second public advisory committee held
    on breast implants.

Summary Basis of Decision
  • In the past, when new drugs were approved, the
    basis on which the decision was made was not
  • Health Canada have announced that they will
    provide a Summary Basis of Decision for all drugs
    approved after Jan 1, 2005.
  • To date, six have issued Crestor, Fabrazyme,
    Lyrica, Velcade, Zemplar and Macugen

Clinical Trial Information
  • There is a belief that industry does not
    disclose negative results from clinical trials.
  • Several leading journals (including CMAJ) have
    announced that they will no longer publish
    articles on clinical trials unless the trials
    were registered in a public database, meeting
    certain minimum criteria.
  • FDA has a database that meets requirements.
  • July 7, 2005 Health Canada announced that they
    would be setting up such a database in Canada.

Public Listing of Recalls
  • As of April 2005, all recalls are listed on
    Health Canada website.
  • Information available product, lot numbers,
    reason for recall, hazard level and recalling

Public Disclosure of ADRs
  • May 25, 2005 new web-based database for ADRs
    launched by Health Canada
  • Called MedEffect
  • Provides access to the latest advisories,
    warnings and recalls
  • Promotes the reporting of adverse drug reactions
  • Patients can report directly
  • ADR Database also available
  • Anyone can search ADRs and drugs for all data
    submitted to Health Canada since the early 60s.

Office of Pediatric Initiatives
  • Concern that little is known about drugs in
    children and how to use them, specifically the
  • This office has been set up to promote research
    in children.
  • Proposed legislation changes in Canada would
    allow some exclusivity related to companies doing
    research in children.

Upgrading Pharmacovigilance
  • In addition to transparency, Health Canada has
    focused on upgrading the collection and
    interpretation of pharmacovigilance data.
  • This includes providing money to Health Canada to
    upgrade Health Canada oversight of safety
  • Feb 2005 - 170 million over 5 years provided.

MOU with US
  • Rare ADRs occur in less than one in 10,000
  • Can only be detected post-marketing and by using
    large databases.
  • June 29, 2005 Canada signed a MOU with the US
    Consumer Product Safety Commission to share data
    with the US.
  • Includes postmarketing surveillance and
    enforcement activities.

Mandatory Reporting of ADRs
  • Companies are required to report ADRs but
    physicians are encouraged to report them.
  • Some countries have mandatory reporting systems
    France, Sweden, Norway, Austria, Italy
  • Canada has mandatory reporting of child abuse,
    chemical intoxication and some infectious
  • Health Canada has announced that they want to
    establish mandatory reporting and are currently
    setting consultation on what this would mean.

Upgrade of Canadas ADR System
  • Program is underway to upgrade and modernize
    Health Canadas systems
  • Provide for greater on-line public query capacity
  • Integration of foreign safety
  • Automated signal detection
  • Electronic filing.
  • Provincial governments could more easily monitor
  • Could assist limited reimbursement or delayed

Establishment of New Regional Centers
  • April 2005 new centers opened in Alberta and
  • Now seven centers Halifax, Montreal, Toronto,
    Winnipeg, Saskatoon, Edmonton, Vancouver.

Need for Pharmacovigilance Plans in Submissions?
  • As of November 2005 required in Europe
  • Post approval stability protocols required in
  • Easy to make this a post approval
    pharmacovigilance protocol.
  • I believe this will occur in the next year.

Federal/Provincial Conference on Drug Safety
  • September 2005 Federal Health Minister and BC
    Health Minister (leaders of the National
    Pharmaceuticals Strategy) held a meeting to
    discuss this issue.
  • Involved provincial representatives, health care
    providers, patient reps, industry and researchers
  • Press release indicated that Health Ministers
    were to evaluate how to strengthen real-world
    drug safety and effectiveness and to provide
    report by June 16, 2006.

Response International - Regulatory
New Guidelines
  • US has issued three new guidelines on how to
    document and assess adverse reaction data.
  • WHO organization has issued a new guideline on
    assessing ADRs in clinical trials (CIOMS).
  • Europe is requiring pharmacovigilance protocols
    in submissions.
  • Expectation is that ICH will enter this arena.

Response in Academia
Conflict of Interest
  • April 2005 The Drug Trial published
  • A book focused on the drug trial at the Hospital
    for Sick Children and Dr. Olivieri
  • In Hamilton, the Spectator conducted a 3-month
    investigation of McMasters Faculty of Health
  • Approximately 100 faculty members had financial
    relationships with industry
  • Research funding, clinical trial contracts,
    honoraria, speaking fees, consultancies, stock
    options, sitting on Boards of Directors

Response of Public
Public Response
  • New publications
  • The Drug Trial
  • Dangerous Doses
  • Xx
  • Movies/TV
  • The Constant Gardener.
  • Spring 2006 new movie looking at the
    pharmaceutical industry.
  • Law Order episodes.

Public Response
  • Public Opinion Polls
  • Show distrust of pharmaceutical industry at an
    all-time high.
  • Public response to perceived safety issues is
    that industry is holding back negative data and
    putting their health at risk.

Implications for Marketing
Public Relations
  • There has never been a time for a greater need
    for the industry to tell its side of the story.
  • Trade associations and individual companies need
    to get the benefits that this industry brings to
    the forefront. Otherwise, it will not be told.
  • Stories regarding these benefits need to be
    brought to the public media, e.g., Law and Order.
    Counterfeit medications would be one way to do

  • With the greater disclosure of ADR information
    and risk/benefit data that support decision
    making, there will be more data available for
    litigation purposes.
  • Companies should routinely be monitoring what is
    on this ADR website regarding their products.

Time to Approval
  • Given the concerns about safety, agencies are
    likely to make conservative decisions and to ask
    for more data.
  • Approval of non-life threatening drugs may be
    delayed or consensus requested from advisory

Post Approval Commitments
  • We will see the Canadian system develop to
    require post-approval commitments, either through
    a change to the system, the use of more
    conditional NOCs or the use of postmarketing
  • Will focus on safety assessments in
  • Monitoring ADRs in a small environment in real
    life, e.g., a teaching hospital.
  • These post-marketing commitments will likely have
    an impact on listings for reimbursement.

Use of Large Databases
  • As regulatory agencies try to get at rare ADRs
    (lt1/10,000 patients), large databases will be the
    best place to get this information.
  • We will see large databases adapt themselves
    better to be able to provide this data.
  • We will see regulatory agencies requesting
    companies to use these databases more.

Patient Access to Data
  • Patients will have far greater access to data.
  • They will review the data and share it among
    themselves via the internet.
  • They will begin filling their own ADR forms,
    particularly the patient groups that are
    well-organized and can assist one another.

Direct To Consumer Advertising
  • Ban on Direct to Consumer advertising will
  • US DTC Advertising may well find itself
  • US Trade organization has recently issued new
    guideline that it expects its members to abide by
    regarding DTC advertising.

Risk Management
  • Risk Management in its broadest sense will become
    a strategic function within pharmaceutical
  • Pharmacovigilance and safety is one component of
    risk management for a company.
  • Paramount in the assessment would be the risk to
    the patient.
  • How that risk is explored and defined may need to
    be tightened i.e., move from art to science
    with predetermined numbers and probabilities.

Parting Message…
  • As of October 31, 2005, the US have adapted SPL
    labelling for ALL drug product subject to an NDA.
  • Company submits in SPL. FDA provides SPL to
    National Library of Medicine (NLM). NLM
    maintains database of all approved labelling
    which HMOs and others can use to develop their
    patient labelling etc.
  • Approved labelling is transmitted to NLM within
    10 minutes of approval. From there it is
    available throughout the country.
  • Compare this to the industry stance in Canada
    where we have no electronic database of Product
    Monographs. Nor do we want one because we cant
    be sure that the English version is the same as
    the French version.

  • We have entered a new environment focused on
  • The relationship that industry has with
  • How transparent we are in sharing safety data on
    our products.
  • How close we are to researchers.
  • How much information our patients and customers
    have access to regarding our products.
  • The old environment will never come back. We
    need to learn to function in this new environment
    and address the concerns that are coming to us.
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