Transcript History of FDA and Related Regulatory Agencies (Ch. 1-2)

History of FDA and Related
Regulatory Agencies
Gretchen Bowker
Pearl Pathways
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FDA Mission
• Protect public health
• Safety efficacy and security of approved drugs,
devices, biologics, cosmetics, and food supply
• Advancing public health
• Sharing information
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Structure of FDA
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CBER - Biologics, Vaccines, Blood, Cells/Genes
CDER – Drugs, Rx and OTC, Advertisements
CDRH – Devices and Radiation Emitting products
CFSAN – Food safety, not meat poultry & eggs
CTP – Tobacco product labeling and Ads
CVM – Animal Food and Drug safety and
effectiveness
• ORA – Quality system compliance
• NCTR – Counter terrorism, pathogen monitoring
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Office of Chief Counsel
• Office of Special Medical Programs
– Combination Products
– Good Clinical Practice
– Orphan Product Development
– Pediatric Therapeutics
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InterCenter Agreements
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Define oversight agreements
CDER reviews biologics
CBER reviews devices
Combination products assists with
designations
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Related Agencies
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FTC - false advertisement
CMS – medicare and medicaid reimbursement
CPSC – product safety
SEC – protect investing public
OSHA – employee safety
TTB – alcohol safety
USDA - dairy, poultry, fruit and meat safety
DOC – fish safety
EPA – environment protection
DEA – Illegal drugs
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Bottom Line
• Know the centers and what they do
– CDER
– CBER
– CDRH
– CFSAN
– ORA
• Know the main offices at Chief Counsel
– Combination products
– Orphan drugs
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History of Food Drug and
Cosmetic Laws
Gretchen Bowker
Pearl Pathways
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Highlights
• Pure Food and Drug Act 1906
– Provided the original drug definition still in use
– Provided labeling requirements
– Assumed consumers would make sound decisions
based on accurate labels
• Food, Drug and Cosmetic Act 1938
– “The Act” replaced Pure Food and Drug Act
– Created the NDA process
– Legal basis for current legislation
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After “The Act”
• Added Devices in 1976
• Food beefed up by Nutrition labeling in 1990
• Dietary Supplement Health and Education Act,
aka DSHEA 1994
• Bioterrorism Act 2002
• Cosmetics FD&C safe colorants
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Current Trends
• Orphan Drug act – Orphan drug patents and
grants
• Hatch-Waxman act – Patents and Generics
• Safe Medical Devices Act – defined a device
and required post-market reporting, created
HUDs
• PDUFA – fees for quicker reviews
• FDAMA – Cadre of changes for clinical study
changes and device reporting
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More Current Trends
• MDUFMA – fees for device submissions
• PREA – required pediatric studies or a waiver
• FDAAA – reauthorized PDUFA, MDUFMA,
PREA and added clinical trials.gov
• FDASIA – Not mentioned in the book, but you
should familiarize yourself with the concepts
in your spare time………
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Laws, Regulations and Guidance
• Laws are enacted by Congress aka “The Act”
• Regulations are instructions on how to meet
the law, they create standards aka 21CFR…….
• Guidance defines FDA expectations aka
Guidance for Industry……
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Regulation or Rulemaking Process
• Proposed rules are published in the Federal
Register
• Anyone can send in comments
• FDA can promulgate the rule, extend the
comment period or abandon the rule
• Final rules are published in the Federal
Register
• The public can petition to change a regulation
Good luck!!
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Bottom Line
• History questions are easy to test on
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