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Dr. DelConte\'s Presentation Dr. DelConte\'s Presentation Presentation Transcript

  • Pharmaceutical Marketing and Promotion: The Medical Affairs Perspective
    Tony DelConte, MD
    24 February 2011
  • Technology and science have drastically changed the landscape of health and health care, and only our imagination limits what is possible…
  • Current Pharmaceutical Environment
    Competitive and Risk Adverse
    Employs 400,000 Directly
    2.7 Million jobs associated with the sector
    Contributes $172,000,000,000 to the economy
    $33.2B invested in research
    Weaken the drug industry and you weaken the pillar of the US economy
    NY Times Jan 2005
    View slide
  • FDA Regulatory Background
    1906 - FDA formed, banned interstate commerce in adulterated misbranded food, drink, and drugs
    1938 Federal Food, Drug and Cosmetic Act following deaths of children due to ingestion of Elixir of Sulfanilamide
    Required drugs to be safe
    Eliminated requirement of proving intent to fraud
    1962 amendment
    Required safety and efficacy
    View slide
  • Regulation of Advertising - DDMAC
    • Division of Drug Marketing Advertising and Communication
    • To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated.  This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers
  • Types of Promotional Materials
    Disease Awareness (Help Seeking)
    Coming Soon
    Reminder Ads
    Full Product
    Direct to Consumer (DTC)
  • Disease Awareness
    J & J educational website, "Living with ADHD”
  • Reminder Ads
  • Labeling – Protecting Public Health
    …information must be rigorously truthful, well documented, and not misleading…the labeling of drugs and medical devices gives prescribers and patients reliable guidance about the safety and effectiveness of health care products…
  • What is False and Misleading?
    Better or more effective
    Safer (fewer side effects, less severe)
    Comparability claims without evidence
    Misleading presentation of data
    Promotion outside of labeled uses
  • Roles In Copy Clearance and Promotional Review
  • Medical Role
    Do No Harm
    Establish Scientific Credibility
    Prevent False and Misleading Statements
    Be true to the science
    Assure fair balance
    Support the Brand positioning
  • Hierarchy of Scientific Evidence
    Systematic Review/Multi-center trials
    Randomized Placebo Controlled trials (RCT)
    Observational Studies
    Prospective cohort
    Case Control
    Case Studies
    Expert Opinion
  • Steps to Market Authorization
    Non-Clinical Toxicology
    IND – Investigational New Drug
    Phase I –Safety - small number healthy volunteers
    Phase II – POC, dose ranging –
    efficacy on targeted indications
    Identifies adverse effects and safety risks
    Phase III - safety & efficacy in expanded population
    NDA – New Drug Application
  • How does Crinone 8% work?
     Crinone 8% comes in the form of a bioadhesive gel
    This gel is squeezed from an applicator…progesterone is absorbed and transported to the uterus.
  • February 2000
    The TV effort from CDM, New York, sought to capitalize on the romantic mood of the month; it featured a couple in a romantic moment and told viewers to "be sweet" and "be playful."
  • FDA Response February 2000
    Rita Wittich 
Director, Regulatory Affairs 
Pfizer Pharmaceuticals 
235 East 42nd Street 
New York, NY 10017-5755
    RE: NDA 20-895 
      Viagra (sildenafil citrate) tablets 
    Dear Ms. Wittich:
  • Your “Valentine’s Day” broadcast advertisement for Viagra contains written and graphic representations and suggestions about Viagra, yet fails to include information relating to Viagra’s major side effects and contraindications.  In addition, in the absence of a brief summary, the advertisement fails to make adequate provision for disseminating the approved product labeling.
  • DDMAC requests that Pfizer immediately cease using this advertisement and all other promotional materials for Viagra that contain the same or similar presentations.  Pfizer should submit a written response to DDMAC, on or before February 17, 2000, describing its intent to comply with the above. Your written response should include a list of promotional materials that were discontinued, and the discontinuation date.
  • Research doesn't support the idea that risks and benefits should be fully communicated in broadcast ads. And expecting patients to become experts simply by viewing a commercial doesn't make a lot of sense. I don't advocate standardized warning messages. But I am in favor of giving people tools to use drugs safely. DTC should generate interest, not attempt to fully educate patients.
    Lou Morris 2006
  • Progenitorivox Ad
  • Weltramax arthritis