this work was made possible by a grant from the state attorney general consumer & prescriber...
TRANSCRIPT
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
U.S. Food and Drug Administration
Practices, People, Politics and Prescriptions
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Mission
http://www.fda.gov/opacom/morechoices/mission.html
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Overview
• Development & Evolution of the FDA
• Limitations of the FDA Regulatory System
• Contemporary Challenges Facing the FDA
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Development & Evolution Cycle• Crisis – Public health
disaster
• Legislation – Congressional response
• Adaptation – Steps FDA took to implement the new law
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Early Medicines
• Buyer beware
• Boastful and extravagant claims
• Alcohol as the main ingredient
• Addictive and dangerous ingredients
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Significant Milestones in Drug Law
• Biologic Control Act 1902
• Pure Food and Drugs Act of 1906
• Federal Food, Drug and Cosmetic Act of 1938
• Durham-Humphrey Amendment of 1951
• Kefauver-Harris Drug Amendments of 1962
http://www.fda.gov/opacom/backgrounders/miles.html
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
A Public Outcry for a New Law• Upton Sinclair’s book, The Jungle,
drew attention to adulterated meat (Meat sales dropped by 1/3)
• Roosevelt was persuaded to sign Pure Food and Drugs Act on June 30, 1906 along with the Meat Inspection Act
• 1906 Act transformed a scientific bureau into a regulatory agency that would become FDA
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
1906 Pure Food and Drugs Act
• “Adulteration” and “Misbranding
• Prohibited interstate transport of unlawful products
• New labels• Sanctioned drug
standards
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Limitations of the 1906 ActCrazy Crystals Radio/Print Advertising…
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
A Turning Point
• Elixir Sulfanilamide
– First wonder drug– Used untested “solvent” DEG– Proved deadly– Legal Implication…
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Federal Food, Drug, and Cosmetic Act 1938
• Pre-market safety approval of all new drugs• Prohibited false therapeutic claims for drugs• Drugs labeled with adequate directions for safe
use• Food standards “in the interests of consumers”• Cosmetics and medical devices under FDA’s
jurisdiction
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
A Disaster Averted Thalidomide
• Sedative sold over-the-counter in Europe – Treated morning sickness during
pregnancy– Produced birth defects in European
babies
• FDA received application for marketing in the US– Reviewer Frances Kelsey had concerns – Delay in approval prevented its being
sold in US
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Amendments – 1960-80s
• Kefauver-Harris Amendments - the most significant changes in the Food, Drug and Cosmetic Act
– Pre-market efficacy and safety– Good manufacturing practices– Prescription drug advertising
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Drug Regulation Changes
• New drug approvals based on safety AND efficacy
• Required GMPs and later GLPs
• New controls over Rx advertising
• New patient protection policies
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Significant Milestones in Drug Law• Tamper-Resistant Packaging Regulations of 1982
• Orphan Drug Act of 1983
• Drug Price Competition & Patent Term Restoration Act of 1984
• Prescription Drug Marketing Act of 1987
• Medicare Prescription Drug Improvement & Modernization Act of 1997
• Prescription Drug User Fee Act (PDUFA) of 1992, 1997, 2002, 2007
http://www.fda.gov/opacom/backgrounders/miles.html
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Critical Thinking QuestionsGiven the history of the U.S. Food and Drug Administration (FDA) as a regulatory agency constantly reacting to a series of “crisis---legislative---adaptation cycles:
1. What do you think the U.S. medication system would be like if these regulations were not in place?
2. Do you think the U.S. is on the verge of another “crisis”--legislative—adaptation cycle?
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Overview
• Development & Evolution of the FDA
• Limitations of the FDA Regulatory System
• Contemporary Challenges Facing the FDA
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Mission
• http://www.fda.gov/opacom/morechoices/mission.html
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Modern FDAModern FDA
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20
(Borchers AT, et al. The history and contemporary challenges of the US Food and Drug Administration. Clin Ther 2007;29:1-16)
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NCTR CBERCDRH
CFSAN CVM
Food and Drug Administration
Center for Drug Evaluationand Research
CDER
ORA
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http://www.gpoaccess.gov/cfr/index.html
IndustryGuidance
IndustryGuidance
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PRE-CLINICALRESEARCH
FDA & INDUSTRY TIME
FDA TIME
INDUSTRY TIME
SPONSOR/FDA MEETINGS ENCOURAGED
DIS
CO
VE
RY/S
CR
EE
NIN
GSYNTHESISAND PURIFICATION
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DIS
CO
VE
RY/S
CR
EE
NIN
GPRE-CLINICALRESEARCH
SYNTHESISAND PURIFICATION
ANIMALTESTING
SHORT-TERM
LONG-TERM
IND
CLINICAL STUDIES
NDAFDA & INDUSTRY TIME
INDUSTRY TIME
SPONSOR/FDA MEETINGS ENCOURAGED
FDA TIME
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DIS
CO
VE
RY/S
CR
EE
NIN
GPRE-CLINICALRESEARCH
SYNTHESISAND PURIFICATION
ANIMALTESTING
CLINICAL STUDIES
PHASE 3
PHASE 1
PHASE 2
FDA REVIEW
SHORT-TERM
LONG-TERM
IND NDA/ BLAFDA & INDUSTRY TIME
INDUSTRY TIME
SPONSOR/FDA MEETINGS ENCOURAGED
FDA TIME FDA ACTION
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PHASE 1 PHASE 2 PHASE 3
CLINICAL STUDIES
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DIS
CO
VE
RY/S
CR
EE
NIN
GPRE-CLINICALRESEARCH
SYNTHESISAND PURIFICATION
ANIMALTESTING
PHASE 3
PHASE 1
PHASE 2
PHASE 4
CLINICAL STUDIES
ADVERSEREACTION
SURVEILLANCEPRODUCT DEFECT
REPORTING
POSTMARKETING
SURVEYS/SAMPLINGTESTING
POST APPROVALINSPECTIONS
SHORT-TERM
LONG-TERM
FDA REVIEW
PARALLEL TRACK
TREATMENT USE
ACCELERATED APPROVAL
ACCELERATED REVIEW: SUBPART E
ACCELERATED REVIEW
EEXPANDED ACCESS:
PARALLEL TRACKTREATMENT USE
IND NDA/BLA FDA ACTIONFDA & INDUSTRY TIME
INDUSTRY TIME
SPONSOR/FDA MEETINGS ENCOURAGED
FDA TIME
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New Drug Application (NDA) or Biologic License Application
(BLA) contains the following:
• Pre-clinical studies
• Human clinical studies
• Manufacturing details
• Labeling – Indication(s)
• Additional information
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ODE I ODE II ODE III ODE IV ODE V
Neuro-pharmacological
Oncology
Cardio-Renal Metabolic andEndocrine
Pulmonary
Gastrointestinal and Coagulation
Anesthetic, Critical Care,
and Addiction
Medical Imaging and
Radiopharmaceuticals
Anti-Viral
Anti-Infective
Special Pathogen
and Immunologic
Anti-Inflammatory, Analgesic and Ophthalmologic
Dermatologic and Dental
Over-the-Counter
Reproductiveand Urologic
ODEVI
TherapeuticBiologicalOncology
TherapeuticBiological
InternalMedicine
ReviewManagement &
Policy
DRUG PRODUCT DIVISIONS
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Review Team
Project ManagerMedical OfficerChemistMicrobiologistStatisticianPharmacologistEstablishment/Facility ReviewerSupport Personnel
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• Panel of OUTSIDE experts• Provide advice and opinions to the FDA drug review team • FDA advisory committee
information, 1-800-741-8138 or 301-443-0572
ADVISORY COMMITTEE
http://www.fda.gov/oc/advisory/default
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Prescription DrugUser Fee Act (PDUFA)
http://www.fda.gov/oc/pdufa/default.htm
• Permits CDER/CBER to charge pharmaceutical manufacturers a fee to review drug applications
• These fees provide appropriate resources to accelerate the review of applications
• Not the only source of funds for CDER/CBER
• Funds go directly to CDER/CBER, not individuals
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DIS
CO
VE
RY/S
CR
EE
NIN
GPRE-CLINICALRESEARCH
SYNTHESISAND PURIFICATION
ANIMALTESTING
PHASE 3
PHASE 1
PHASE 2
PHASE 4
CLINICAL STUDIES
ADVERSEREACTION
SURVEILLANCEPRODUCT
DEFECTREPORTING
POSTMARKETING
SURVEYS/SAMPLINGTESTING
POST APPROVAL
INSPECTIONS
SHORT-TERM
LONG-TERM
FDA REVIEW
IND NDABLA
ACTIONFDA & INDUSTRY TIME
INDUSTRY TIME
SPONSOR/FDA MEETINGS ENCOURAGED
FDA TIME
PARALLEL TRACK
TREATMENT USE
ACCELERATED APPROVAL
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Post-market Surveillance
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Potential Regulatory Action for Postmarketing Safety Issues
• Labeling Change
• Scientific publication
• "Dear Doctor" letter (for specific warnings)
• Restricted use
• Restricted distribution
• Patient Medication guide
• Product withdrawal
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Office of Drug Safety
• Division of Drug Risk Evaluation
• Division of Medication Errors and Technical Support,
• Division of Surveillance, Research, and Communication Support
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MedWatch Website
• Safety Information Retrieval
• Adverse Event Reporting for Drugs,Devices, Biologics and Dietary Supplements
www.fda.gov/medwatch
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• Database
• Internationally compatible
Adverse Event Reporting System (AERS)
Office of Drug Safety (ODS) uses AERS to:
• triage
• review
• assess risk
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DDMAC (Division of Drug Marketing Advertising and Communications)
• Promotional Materials Review
• Guidance and policy development
• Research
• Surveillance and enforcement
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CDER’s Office of Compliance
• Sets labeling, manufacturing, and testing standards
• Monitors the quality of marketed drugs
• Evaluates, classifies, and recommends human drug recalls
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Can We Improve the Current FDA System
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Overview
• Development & Evolution of the FDA
• Limitations of the FDA Regulatory System
• Contemporary Challenges Facing the FDA
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Problems With the Current System?
1. Initial review for approval often fails to detect serious ADR’s
2. FDA’s surveillance system is plagued with underreporting
3. Threshold for action in response to ADR reports is subjective
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Problems With the Current System?
4. Performance of post-marketing surveillance studies is out of FDA controls
5. FDA lacks direct legal authority to hold accountable drug companies that violate its recommendations
6. FDAs intrinsic structure is viewed as presenting a potential conflict of interest
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Problems With the Current System?
7. FDA is highly dependent on user fees
8. Shortage of FDA expertise in drug safety and public health
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Vision for the Next Century
• Critical Path Initiative
– Transform medical product development
– Keep pace with expected medical advances
http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Debate on Current FDA Issues• Independent Agency
– Transperent– Accountable
• Science-based– Enhanced Predictive Tools– Allow for Disagreement
• Increased Legal Authority– Enforcement/Oversight– Minimize Conflict of Interest
• Culture of Safety– Enhanced Communication
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Perspective Practices, People and
Politics
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Classroom Activities• Post-Marketing (Phase IV) studies
• Medicare Prescription Drug Improvement & Modernization Act of 1997
• Prescription Drug User Fees• Act (PDUFA) of 1992, 1997, 2002, 2007
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Classroom Discussion• Post-Marketing (Phase IV) studies
• Medicare Prescription Drug Improvement & Modernization Act of 1997
![Page 52: This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state](https://reader035.vdocuments.site/reader035/viewer/2022062407/56649ca55503460f94965f35/html5/thumbnails/52.jpg)
This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Classroom Discussion• Prescription Drug User Fees
• Act (PDUFA) of 1992, 1997, 2002, 2007
![Page 53: This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state](https://reader035.vdocuments.site/reader035/viewer/2022062407/56649ca55503460f94965f35/html5/thumbnails/53.jpg)
This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Perspective Practices, People and
Politics• Protecting the Health of the Public
http://content.nejm.org/cgi/content/full/355/17/1753/DC1
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This work was made possible by a grant from the state Attorney General Consumer & Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin®.
Perspective
Put this information in the context of your:
• Group assigned medication exercise• Classroom learning• Direct-patient care activities next year• Professional practice
“Be a part of the DEBATE”
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ChallengesAre We Headed for Another Public
Health Crisis?