Transcript Prescription Drug Labeling

Development and Regulation of
Medical Products
(MEDR-101)
Prof. Moustafa M. Mohamed
Vice dean
Dr. Safa Ahmed El-askary
Faculty of Allied Medical Science
Pharos University in Alexandria
Lecture (5)
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Event History leading to FDA regulation of drug labeling
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Laws that regulate prescription drug labeling and
promotional materials
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Scope of labeling components and their content
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Significance of promotional labeling and DTC Advertising
and why FDA regulates these materials
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Current topics in prescription drug labeling
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Where to find current information related to prescription
drug labeling
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Essential scientific information needed for safe
and effective use
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Informative, accurate, not promotional or
misleading
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Based on human experience, whenever possible
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Animal data when necessary for safe and
effective use
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Federal Register
 Legal newspaper published daily, contains current federal agency
regulations, proposed rules, and Executive orders.
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Code of Federal Regulations (CFR)
 CFR codifies final rules published in Federal Register
 Divided into titles an subparts representing broad areas subject to
Federal regulation
 Updated yearly and issued quarterly
▪ Code of Federal Regulations: About
 21CFR201:Drug Labeling - Title 21-Drugs, Subpart 201-Labeling
▪ Labeling Requirements for Prescription Drugs and Insulin
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Laws
 Laws Enforced by the FDA
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Professional Labeling
Immediate Container/ Outer package
Patient Product Information
Medication Guide
Promotional Labeling
DTC Advertising
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Description
 name, dosage form, ingredients, sterility, class, structure)
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Animal pharmacology
Clinical Pharmacology
Clinical Studies
Indications and Usage
Contraindications
Warnings
Precautions
 General precautionary information
 Drug interactions; carcinogenicity, mutagenesis, fertility;
 Pregnancy/ nursing mothers;
 Special Populations
Professional Labeling: Isotrentinoin
1.
Statement of identity
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2.
Net quantity of contents
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3.
5.
Weight, measure, numerical count, combination
Statement of usual dosage
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4.
Established name, Ingredients
“See package insert”
Expiration date
Name and place of business of manufacturer, packer, or
distributor
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Extension of professional labeling for the patient
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Distributed to patients when dispensed and includes
Important information in consumer-friendly language
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May describe benefits, risks, how to recognize risks,
dosage and administration
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May Include Special Notices (Boxed Warnings)
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Required for certain drugs
 oral contraceptives (21 CFR 310.501)
 estrogens (21 CFR 310.515)
 progestational drug products (21 CFR 310.516)
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Voluntary for other drugs
Patient Product Information
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Serious and significant public health concern
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Significant risk:benefit issue(s) that may affect
patients’ decisions to use, or continue to use the
product
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Patient compliance (i.e., adherence to directions for
use) is crucial to drugs safety/ effectiveness
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Where additional information could help prevent
serious adverse effects
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Where drug would used primarily in an outpatient
setting without supervision of health professional
 Brand name
 What is the most important information I should know
about (name of drug)?
 What is (name of drug)?
 Who should not take (name of drug)?
 How should I take (name of drug)?
 What should I avoid while taking (name of drug)?
 What are the possible or reasonably likely side effects
of (name of drug)?
 Additional headings
Accutane Medication Guide
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The Food and Drug Modernization Act
of 1997 (FDAMA) - FDAMA Homepage
Pre“On-Label” Indications are
listed in FDA approved
labeling, however, FDA does
not dictate the medical
practice
Drug sponsors may not
discuss, promote or distribute
materials that encourage “offlabel” use
Promotion of “Off-label” use
by sponsors would:
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Diminish use of evidencebased medicine
Expose patients to
unidentified risk or harm
Post Firms may distribute information
related to new (unapproved) use
of approved drug, prior to FDA
approval, if:
 Reprint or copy of a peer-
reviewed scientific or medical
journal article, or reference
publication, about a clinical
investigation
 Is not false or misleading and
does not pose a significant risk to
the public health
 Manufacturer must submit copy
to FDA (DDMAC) 60 days prior to
dissemination
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Direct-to Consumer (DTC) promotion for purpose to
enhance patient awareness of disease states, available
therapies, potential side effects
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Includes magazines, newspapers, broadcast (TV/radio),
internet dissemination/ advertising of drug information
to physicians and patients
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May be product-claim, reminder or help-seeking
advertisements
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New form of product labeling with specific regulation by
DDMAC
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Before 1980, No DTC promotion
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1983 – Voluntary Moratorium
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1985 – Policy Statement, Sufficient
Safeguards
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1990’s – Promotional Message/ Brief
Summary (AEs)
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Mid 1990s – “Reminder Ads”
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1997 – FDA Draft Guidance
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Division of Drug Marketing, Advertising and
Communication (DDMAC)
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Regulates DTC promotional labeling
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Ensures truthful, balanced and accurate
communication of drug information to the public
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Post-Hoc evaluation, most recommendations to
“Stop or Discontinue” due to false, misleading or
unbalance representation
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Untitled Letters– notice of violation
Warning Letters – More serious violations
Injunctions and Consent Decrees
Criminal Investigation or Prosecution
Product Seizure
Thanks