This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
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The Other Agency: An introduction to Pharma Marketing
1. The Other Agency:
How the FDA affects everything we do
Presented by
Dale A. Cooke
@PhillyCooke
Vice President/Group Director, Regulatory Review
Digitas Health
2. 2
At the end of this presentation you will
understand…
> The role of the FDA in the development and
marketing of prescription medicines
> The key regulations and principles that apply to every
promotion of a prescription medicine
4. 4
Drug Development Process
Clinical Trials
Drug
Discovery
Pre-Clinical/
Laboratory
Trials
Phase 1
20 – 100
Subjects
Safety &
Dosage
Range
Studied
Phase 2
100 – 500
Subjects
Safety &
Optimal
Dosage/
Schedule
Studied
Phase 3
1,000 – 5,000
Subjects
Safety &
Effectiveness
Studied
INDFiled
NDAFiled
FDA Filing FDA Filing
Phase 3b/4
1,000 – 5,000
Subjects
Additional
Safety or
Efficacy
Studied
sNDAFiled
FDA Filing
5. 5
Drug Development Process
Clinical Trials
Drug
Discovery
Pre-Clinical/
Laboratory
Trials
Phase 1
20 – 100
Subjects
Safety &
Dosage
Range
Studied
Phase 2
100 – 500
Subjects
Safety &
Optimal
Dosage/
Schedule
Studied
Phase 3
1,000 – 5,000
Subjects
Safety &
Effectiveness
Studied
INDFiled
NDAFiled
FDA Filing FDA Filing
Phase 3b/4
1,000 – 5,000
Subjects
Additional
Safety or
Efficacy
Studied
sNDAFiled
FDA Filing
≈10,000 entities
are studied for
1 approved drug
6. 6
Pharma Industry Success
Since 1980 life expectancy for cancer patients has
increased about 3 years and 83% of those gains are
attributable to new treatments, including medicines.
Patients diagnosed with AIDS in 1990 could expect
to live only months…. Since the approval of the
anti-retroviral treatments (ART) in 1995 the AIDS
death rate has dropped by 78%.
A 2007 study in Health Affairs found that use of
antihypertensive medicines prevented 86,000
premature deaths from cardiovascular disease in
2001 and, 833,000 hospitalizations for heart attack
and stroke in 2002.
9. 9
Increase in the number of reports of
violative promotional activities from HCPs 1
1SOURCE: FDA Bad Ad Program Year End Report, 2011
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm258719.htm
Was it successful?
12. 12
What’s in a Brand Name?
•Brand Name = Trade Name = Proprietary Name
•Generic = Established Name
Brand Name
Generic
13. 13
Regulations
•Featured Use
“the established name…shall accompany …[brand]
name…each time it is featured”
•(21 CFR 202.1(b)(1))
•Body Copy
if the brand name “is not featured but is used in”
body copy, then the established name must accompany
the brand name “at least once” [on each page]
•(21 CFR 202.1(b)(1), emphasis added)
15. 15
Logo Design
•Featured Use
“the [generic] name is required to be…at least half as
large as …the [brand] name”
• (21 CFR 201.10(g)(1) and (2); 202.1(b)(1) and (2))
“the [generic] name shall have a prominence
commensurate with the…[brand] name…taking into
account…typography, layout, contrast, and other
printing features”
• (21 CFR 201.10(g)(2) and 202.1(b)(2))
16. 16
TV Spots: Supers & Audio
“[T]he [generic] name [should] be displayed on the screen for the
same amount of time as the [brand] name. For superimposed text
that typically runs along the bottom of the screen, the [generic]
name does not have to be included…. FDA also recommends that
the [brand] name be included in the audio…with the most
prominent display of the proprietary name. Under most
circumstances, this is the first occurrence in the broadcast.”
— From Guidance for Industry: Product Name Placement, Size,
and Prominence in Advertising and Promotional Labeling
17. 17
Fair Balance
Prescription drug advertising must “present a fair balance
between information relating to side effects and
contraindications and information relating to effectiveness
of the drug.”
- 21CFR202.1(a)(1)
22. 22
Reminder Advertising
•What is it?
“Reminder advertisements ... call attention to the name
of the drug product but do not include indications or
dosage recommendations ....”
•- From 21CFR202.1.e2
31. 31
Unbranded Advertising
We call these “Unbranded.”
FDA calls them “Help-seeking” or “Disease Awareness”
“Disease awareness communications are communications
disseminated to consumers or health care practitioners that
discuss a particular disease or health condition, but do not
mention any specific drug or device or make any representation
or suggestion concerning a particular drug or device.”
•- Guidance for Industry "Help-Seeking" and Other Disease Awareness
Communications by or on Behalf of Drug and Device Firms, FDA 2004
33. 33
PI vs. PPI vs. MG vs. PMI
PI = Package Insert
(Prescribing Information & Product Information)
PPI = Patient Prescribing Information
(sometimes called PI = Patient Information)
MG = Medication Guide
PMI = Patient Medication Information
34. PI vs. PPI vs. MG vs. PMI
PI PPI MG PMI
Product
Class
All Prescription
Drugs
Products with
Complex Usage
Products with a
Safety Concern
Some
Prescription
Drugs
Who Is It
Written for?
Physicians Consumers Consumers Consumers
Present for
All Drugs?
Yes No No No
Document
Author
Product
Manufacturer
Product
Manufacturer
Product
Manufacturer
Pharmacy
Subject to
FDA
Mandate?
Yes Yes Yes No
Dispensed
with
Prescription?
No No* Yes Yes
* Certain classes of drugs (particularly hormone treatments) have a required PPI, and for
those drugs, the PPI must be distributed with every prescription.
35. 35
“Safe & Effective”
•Safe
> 1938 Food, Drug, and Cosmetic Act
> No regulatory definition, but gain must outweigh risks
•Effective
> 1962 Kefauver-Harris Drug Amendments
> Effective for what?
> Establishes the notion of an indication
> Two double-blind, placebo-controlled studies
36. 36
Off-label Promotion
What is off-label promotion?
> Any discussion that goes beyond the established PI
Off-label usage by physicians is legal and quite common
What can be done legally by pharma?
> Respond to physician-initiated questions
> Provide reprints of scientific research
38. 38
Dale Cooke
VP/Group Director, Regulatory Review
• Dale Cooke is the head of the Regulatory Review department for Digitas
Health. He has worked with more than 25 pharmaceutical and medical
device clients and with Medical-Legal-Regulatory committees around the
world from offices in Philadelphia, New York, Boston, and London. Dale
advises clients on FDA enforcement actions and provides recommendations
for compliance with FDA regulations, with a focus on issues involving the
Internet and emerging technology. His insights have been featured in the
Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec,
and others. Dale is a member of the Regulatory Affairs Professionals
Society (RAPS) and the Food and Drug Law Institute (FDLI).
• Dale is the author of Effective Review and Approval of Digital Promotional
Tactics, which is part of the FDLI primer series. He is regularly invited to
speak at industry conferences on topics including FDA enforcement trends,
best practices for review processes, global review practices, and
pharmaceutical involvement in social media.
• Dale earned his B.A. in Philosophy from Southern Methodist University and
an M.A. in Analytical Philosophy from the University of Arizona and studied
Epidemiology and Biostatistics at Drexel University’s School of Public
Health. Before joining Digitas Health, Dale was with ARAMARK overseeing
proposal development for government and industry clients.