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Regulation of labeling and promotion



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  • 1. Regulation ofLabeling andPromotionByDR.Alaa Essmat
  • 2. Legal Risks• Drug Cannot Be Marketed• Drug Can Be Removed From TheMarket• Civil Fines• Criminal Prosecution• Tort Judgments• Bankruptcy2
  • 3. Why Is Labeling So Important?• All Drugs Pose Risks– Inherent Risks– Risks Due To Interactions With OtherDrugs– Risks Due To Disease States– Risk Of Over and Under Dosage• NO RISKS ARE OBVIOUS!3
  • 4. Manufacturers Have The MostInformation• Clinical Trials Under The IND– Proprietary Information– Controlled By The Manufacturer– Should Be Reported To The FDA• Post-Market Information– Manufacturer Gets Primary Reports– Should Pass Information To The FDA4
  • 5. What is a Label - I• "Brochures, booklets, mailing pieces,detailing pieces, file cards, bulletins,calendars, price lists, catalogs, houseorgans, letters, motion picture films, filmstrips, lantern slides, sound recordings,exhibits, literature, and reprints andsimilar pieces of printed, audio or visualmatter descriptive of a drug andreferences published (for example, thePhysicians Desk Reference)5
  • 6. What is a Label - II• for use by medical practitioners,pharmacists, or nurses, containingdrug information supplied by themanufacturer, packer, or distributorof the drug and which aredisseminated by or on behalf of itsmanufacturer, packer, or distributorare hereby determined to be labelingas defined in section 201(m) of theFD&C Act."6
  • 7. Rx Drugs• Physician Information– Package Insert– Information Sheets For Physicians• Depends on Expertise of Physician• Rarely, Patient Package Insert– When Patients Have Significant ControlOver Choice of Drugs– Birth Control Pills7
  • 8. OTC• On The Box• Insert In The Box• Must Allow Safe Use By Consumer• Labeling Issues Often DetermineWhether A Drug Is OTC or Rx8
  • 9. Labels Can Make The Drug• Apple Cider Vinegar Alone is not aDrug– Apple Cider Vinegar with a Label thatSays It Will Cure Cancer is a Drug,Subject to FDA Regulation– Also Subject to FTC Regulation• Does a Book Saying it TreatsCancer Make it a Drug?• Is the Author Guilty ofMisrepresentation?9
  • 10. Product Independent Labels• Pamphlets And Flyers– Are They Provided With The Drug Or ToPersons Who Buy The Drug?– Are They Necessary To Use The Drug?– Do They Undermine Or Conflict With TheFDA Approved Label?• What If The Pharmacy ProvidesThem Independently of theManufacturer?10
  • 11. FDA Standards• A Drug is Misbranded If:– [Its] "labeling is false or misleading inany particular" or– the labeling does not bear "adequatedirections for use."• Drugs are Misbranded if theManufacturer Does Not Use the FDAApproved Label Information• Misbranded Products Cannot Be Sold11
  • 12. Federal Trade CommissionStandards• Misleading Or Deceptive• FTC Looks At All Advertising AndPromotional Materials• Penalties– Civil Fines– Criminal Prosecution• Usually Secondary To The FDA For Drugs• Governs Medical Products That Are NotUnder the FDCA12
  • 13. Tort Law Standards• Must Provide Full PrescribingInformation• Must Provide All Side-effects andContraindications• Must Anticipate Misuse and WarnAgainst it• Must Quickly Add Any NewInformation about the Drug13
  • 14. FDA Standard for an Rx DrugLabel• Labeling must include the establishedname, proprietary name (if any),adequate directions for use, andadequate warnings. The agencyconsiders the approved productlabeling, sometimes called the fullprescribing information, to beadequate directions for use andadequate warning.14
  • 15. Are there exceptions to therequirements for labeling?• Reminder labeling, as defined in 21 CFR201.100(f), is exempted.• Reminder labeling calls attention to thename of the drug product but does notinclude indications or dosagerecommendations for use. Reminderlabeling may contain only theproprietary name of the drug, theestablished name of each activeingredient, and optionally, informationrelating to quantitative ingredientstatements, dosage form, quantity ofpackage contents, price, and otherlimited information.15
  • 16. What the Label Cannot Have• Unapproved Uses– Only Uses From Approved NDAs– Hence "Off-Label" Uses• Disputes with the FDA• No Over-Warning– CYA in Tort Cases– Interferes with Rational Prescribing16
  • 17. Patient Package Inserts• Legal Authority To Require?• Regulatory History• Why Did Physicians Oppose Them?• What Drugs Must Have Them Now?• Why Is The FDA Interested In ThemAgain?17
  • 18. Promotional Materials• Real Issues– Off Label Uses– Inappropriate Use• FDA Authority Over PromotionalMaterials– Can The FDA Control What DetailmenSay?– How Have Companies Gotten InTrouble?18
  • 19. FDA Definition of PrescriptionDrug Advertising• 21 CFR 202.1(l)1 states that advertisementssubject to Section 502(n) of the Food, Drug, andCosmetic Act (FD&C Act) include advertisementspublished in journals, magazines, otherperiodicals, and newspapers; and broadcastthrough media such as radio, television, andtelephone communications systems. This is not acomprehensive list of advertising media subjectto regulation. For example, FDA also regulatesadvertising conducted by sales representatives,on computer programs, through fax machines, oron electronic bulletin boards.19
  • 20. What must a prescription drugadvertisement include?• Under section 502(n) of the FD&C Act,advertisements must include: theestablished name, the brand name (ifany), the formula showing quantitativelyeach ingredient, and information in briefsummary which discusses side effects,contraindications, and effectiveness. Thebrief summary is further discussed in 21CFR 202.1(e)(1).20
  • 21. Are there exceptions to theadvertising regulations?• Yes, there are a few exceptions butonly to the requirement to provide atrue statement of information in briefsummary as required under 21 CFR202.1(e)(1).21
  • 22. 21 CFR 202.1(e)(2) describeswhich ads are exempt:• Reminder advertisements– advertisements which call attention to the name ofthe drug product but do not include indications ordosage recommendations for use of the product, orany other representation. Reminder ads contain theproprietary name of the drug and the establishedname of each active ingredient. They may alsocontain additional limited information, such as thename of the company, price, or dosage form.• Advertisements of Bulk-sale drugs• Advertisements of prescription-compoundingdrugs– promote sale of a drug for use as a prescriptionchemical or other compound for use by registeredpharmacists. 22
  • 23. Providing Information OnUnapproved Uses• The Manufacturer Cannot AdvertiseUnapproved Uses• The Manufacturer Can Send Out MedicalJournal Reprints On Unapproved Uses– Must Log and Notify FDA– May Have to Retract if the Science Changes• Must A Manufacturer Warn Against KnownUnapproved Uses?23
  • 24. Requirements for Direct toConsumer Ads• All the contraindications• All the warnings• All the major precautions• All other frequently occurring sideeffects that are likely to be drug-related• Include Contact Phone and URL24
  • 25. Internet Information• WWW Pages are Subject To FDARegulation• Non-Manufacturer Sites– Can Pharmacies Tout Unapproved Uses?– What about Access to Rx Drugs withoutan Rx?• Can Manufacturers Link To Non-Manufacturer Sites?25
  • 26. Tort Implications of DirectAdvertising• Undermines Learned IntermediaryDefense• Can Trigger a Duty to Warn thePatients Directly– Makes Rx Drugs More Like OTC– Must the FDA Approve a Voluntary PPI?26
  • 27. Future Issue• Commercial Speech Restrictions OnFDA Authority• Blurring of OTC And RX LabelingBecause Of Internet Sales• Shifting Of Warning Duties ToPharmicists• Changing Labeling Standards AsStates License Non-PhysicianPrescribers27