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Promotion of Prescription Drugs and Biologics

Promotion of Prescription Drugs and Biologics. Thomas O. Henteleff Kleinfeld, Kaplan and Becker LLP. Company logo here. Scope of FDA Regulation. Labeling Rx Advertising Other Promotional Vehicles Sales Presentations Educational/marketing events. Jurisdiction. Rx Drugs Review Division

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Promotion of Prescription Drugs and Biologics

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  1. Promotion of Prescription Drugs and Biologics Thomas O. Henteleff Kleinfeld, Kaplan and Becker LLP Company logo here

  2. Scope of FDA Regulation • Labeling • Rx Advertising • Other Promotional Vehicles • Sales Presentations • Educational/marketing events

  3. Jurisdiction • Rx Drugs • Review Division • Division of Drug Marketing, Advertising and Communications (Thomas W. Abrams) • Biologics • Review Division • Advertising & Promotional Labeling Branch (Maryann Gallagher)

  4. Jurisdiction (cont.) • Over-The-Counter Drugs • Advertising - Federal Trade Commission • Labeling - FDA

  5. 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.

  6. 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

  7. 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

  8. 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

  9. Direct-to-Consumer • Current FDA initiative • Brief Summary • Broadcast Ads • Major Statement • Adequate Provision

  10. 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

  11. 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

  12. 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)

  13. 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

  14. FDAMA Section 401 • Safe harbor to disseminate info about off-label uses of approved drugs in limited circumstances (21 C.F.R. Part 99) • Detailed, burdensome requirements • Authorized information • Authorized audience/recipients • Prior notice to FDA/sNDA filing • Mandatory disclosures

  15. 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

  16. 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

  17. 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

  18. 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)

  19. 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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