Transcript Promotion of Prescription Drugs and Biologics

Promotion of Prescription Drugs
and Biologics
Thomas O. Henteleff
Kleinfeld, Kaplan and Becker LLP
Company
logo here
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Scope of FDA Regulation
• Labeling
• Rx Advertising
• Other Promotional Vehicles
– Sales Presentations
– Educational/marketing events
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Jurisdiction
• Rx Drugs
– Review Division
– Division of Drug Marketing, Advertising and
Communications (Thomas W. Abrams)
• Biologics
– Review Division
– Advertising & Promotional Labeling Branch
(Maryann Gallagher)
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Jurisdiction (cont.)
• Over-The-Counter Drugs
– Advertising - Federal Trade Commission
– Labeling - FDA
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Labeling vs. Advertising
• Labeling – written, printed, or graphic
matter “accompanying” the drug
– No physical connection required; textual
relationship is key (e.g., website)
– Defined by regulation to include brochures,
booklets, detail pieces, catalogs, price lists,
bulletins, etc (21 C.F.R. § 202.1(l)(2))
• Advertising – generally paid media
– Journals, magazines, TV, radio, etc.
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General FDA Requirements
• Not false or misleading
– Affirmative (mis)statements & failure to
reveal material facts
• Consistent with approved package
insert (i.e., not “off-label”)
• Adequately supported by scientific
evidence
• Fair Balance
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Submissions to FDA
• New Drugs/Biologics
– 21 C.F.R. §§ 314.81(b)(3), 601.12(f)(4)
– Labeling & advertising: at initial dissemination or
publication
• Accelerated Approval (§§ 314.550, 601.45)
– Initial (for use during 1st 120 days) labeling &
advertising must be submitted before approval
– Thereafter, 30 days prior to first use
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Types of Ads
• Preapproval
– Coming Soon Ads
– Institutional Ads
• Post-approval
– Full Product Ads
– Reminder Ads (21 C.F.R. § 202.1(e)(2)(i))
– Comparative Ads
• Help Seeking/Disease Awareness
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Direct-to-Consumer
• Current FDA initiative
• Brief Summary
• Broadcast Ads
– Major Statement
– Adequate Provision
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Comparative Claims
• Efficacy, safety, or cost comparisons
• Must relate to approved conditions of
use
• Head-to-head data generally required in
support
• Comparison of information in Package
Inserts is not adequate support
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Investigational Drugs
• 21 C.F.R. § 312.7
• Cannot promote or represent as safe or
effective
• Cannot commercially distribute or test
market
• Cannot commercialize by charging
higher price than necessary to recover
costs
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Off-Label Information
• Dissemination of mfr generated off-label
info is strictly prohibited
• Limited ability to disseminated materials
generated by third parties:
– Unsolicited Requests
– FDA Modernization Act of 1997 (FDAMA)
– Washington Legal Foundation Case (WLF)
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Unsolicited Requests
• FDA policy/FDAMA – will not object to
responses to unsolicited requests
 Truly unsolicited – no prompting
 Document the request
 Monitor to detect prompting
 Medical Affairs, rather than Marketing
 Provide objective, balanced
information
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FDAMA Section 401
• Safe harbor to disseminate info about offlabel uses of approved drugs in limited
circumstances (21 C.F.R. Part 99)
• Detailed, burdensome requirements
–
–
–
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Authorized information
Authorized audience/recipients
Prior notice to FDA/sNDA filing
Mandatory disclosures
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WLF Case – 1st Amendment
• 1st Amendment right to exchange of truthful
scientific information relating to off-label uses
• Court’s injunction was overturned as moot,
but decision was procedural and the District
Court analysis is still persuasive
• Very circumscribed dissemination of
information pertaining to off-label uses may
be protected by the 1st Amendment
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WLF (cont.)
• Unaltered bona fide peer-reviewed
journal article or reference textbook
• Only to healthcare professionals
• Product must be approved
• Identify mfr’s interest in product
• Disclose that use is not approved
• Avoid dissemination as a launching pad
for discussion of off-label information
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Continuing Medical Education
• Industry-supported CME is regulated as
promotion if not independent of mfr’s
substantive influence
• 1997 FDA Guidance identifies criteria to
evaluate independence
• Primary issue: discussion of off-label
information
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FDA Enforcement
• Untitled Letter
• Warning Letter
– Cease conduct; possible remedial action
• Adverse Publicity
• Injunction or consent decree
– Kabi Pharmacia (1993)
– Syntex (1991)
– Eli Lilly (2005); Serono (2005); Warner-Lambert
(2004); Tap (2001)
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Eli Lilly (12/2005)
• Off-label promotion of Evista
• Company pled guilty to criminal count of
violating FDCA by misbranding Evista
• Consent decree of permanent injunction
– Detailed compliance requirements
• Criminal fines and disgorgement total
$36 million
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