Dr. DelConte\'s PresentationPresentation 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… http://www.sju.edu/academics/hsb/pharmmarketing/why.html
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)
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 Legal Regulatory Medical Marketing Editorial Traffic/Coordination
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 http://www.youtube.com/watch?v=2-lrd5Kke-k&feature=related