Food and Drug Administration FDA

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Food and Drug Administration (FDA)

• Authorized by Congress to inspect, test, approve
  and set safety standards for drugs, medical
  devices, chemicals, cosmetics, foods and food
  additives, electronic products that emit radiation

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Authorizing Legislation

• Pure Food and Drug Act of 1906
• Federal Food, Drug, Cosmetic Act, 1938
• FDC Act Amendment 1962
• FDC Act Amendment 1996

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Other Legislation/Regulations

• 1976 - Medical Device Amendment
• 1977 - Saccharin Study and Labeling Act
• 1980 - Infant Formula Act
• 1982 - Tamper Resistant Packaging Regulations
• 1983 - Federal Anti-Tampering Act
• 1983 - Orphan Drug Act
• 1990 - Nutrition Labeling and Education Act
• 1990 - Safe Medical Devices Act
• 1992 - Mammography Quality Standards Act
• 1996 - Food Quality Protection Act

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Structure

• Agency within the U.S. Public Health Service in
  U.S. Department of Health and Human Services
• Managed by a commissioner (Jane Henney)
• appointed by President and confirmed by Senate
• Offices in Washington, D.C. and
  Rockville,Maryland plus regional offices

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8 Agencies In FDA

• Office of Management Operations
• Office of Health Affairs
• Office of Science
• Office of Legislative Affairs
• Office of Planning and Evaluation
• Office of Public Affairs
• Office of Consumer Affairs
• Office of Regulatory Affairs

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FDA Resources

• 9530 employees including 1100 investigators and
  inspectors (1999 request)
• FY 1999 budget request of 1,350 million (18
  increase)

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Who Influences the FDA?

• Some Presidents influence through general
  direction, largely through regulatory reform but
  FDA has fared well.
• Congress - laws it passes, appropriations to FDA
  budget, congressional hearings
• Other agencies -- FTC, EPA, USDA, DEA
• Drug manufacturers
• Physicians and patients

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FDA Modernization Act of 1997

• Reauthorizes Prescription Drug User Fees
• Modernizes and streamlines practices
• Allows manufacturers to distribute information
  about unapproved uses of drugs and medical
  devices

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Enforcement Publicity

• Publishes the FDA Consumer Report
• summarizes all seizures and criminal proceedings
• News Conferences
• Press Releases
• Speeches
• Publishes the FDA Enforcement Report
• lists harmful products seized by the FDA

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Warning Letters

• Advise firms that their product(s) may violate
  FDA provisions
• Corrective actions must occur to avoid court
  action

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Recalls

• Recalls a manufacturer is required to remove a
  defective product from the market
• when products are a serious threat to consumers
• Can be both voluntary and involuntary
• Three levels
• Class I
• Class II
• Class III

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Seizure

• Confiscation of a selected good(s) in violation
• goods that contain non-approved additives
• misbranded products
• How does the FDA initiate seizures?
• Files a complaint with the US District Court
• to take possession of products that are in
  violation until the matter is settled
• The manufacturer has 30 days to decide what
  action he/she will take
• do nothing, ask the court for more time, fight
  the FDA in Court

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Injunctions, Prosecutions

• Injunctions - Civil actions filed by the FDA
  against a person/company
• to stop a company from continuing to produce
  products that violate the FDAs guidelines
• involves lengthy, complicated court battles that
  the FDA may not win
• Criminal prosecution is most extreme step
• will only prosecute after detailed and careful
  consideration

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New Drug Development Process

• Company does lab testing followed by animal
  studies - typically 3.5 years
• If those turn out well, company submits an
  Investigational New Drug Application to do
  clinical trials on humans in 3 phases
• Phase 1 - adverse reactions/side effects - 10-50
  people
• Phase 2 - drugs activity safety - 50-100
  people
• Phase 3 - safety efficacy - 200-1000 or more

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New Drug Approval

• 1990 Parallel track protocol policy for drugs for
  AIDS and HIV - begin treating patients during
  clinical trials
• 1992 - Accelerated approval process for new drug
  therapies to teach life threatening illnesses
• Result is significantly shorter drug approval
  time from 19 mo to 16.5 mo more drugs approved

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New Drug Approval

• On average takes 12 years for approval 1 in 5000
  compounds tested are approved
• Major criticism of FDA has been how long approval
  takes
• In 1988 FDA modified the process allows
  manufacturer to skip Phase 3 if Phase 2 goes well
  but adds Phase 4 (post-marketing trials)

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Food Safety Regulation Agencies responsible for
regulating food supply and monitoring food safety

• USDA - Food Safety and Inspection Service (FSIS)-
  meat and poultry eggs live food animals, grains
  and oilseed crops
• FDA - Center for Food Safety and Applied
  Nutrition (CFSAN) all other food products
• FDA and EPA - pesticides
• Public Health Service in HHS monitors food-borne
  illnesses
• State Departments of Agriculture, Public Health,
  Consumer Protection, etc.
• Some states have specific laws

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Food Safety and Inspection Service - USDA

• Visual inspection until 1996 in meat and poultry
• 1996 - Hazard Analysis Critical Control Point
  (HACCP)
• 1994 - Safe Handling Instructions Rule

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FDA - Center for Food Safety and Applied
Nutrition (CFSAN)

• Inspects all foods except meat, poultry, eggs,
  liquor in interstate commerce and food
  processing/handling facilities
• approval of new foods, food additives, and
  pesticides
• 1991 - created Office of Seafood to increase
  inspection of seafoods

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Inspections - FDA Consumer Safety Officers

• make unannounced inspections of food processing
  facilities, food stores, and warehouses

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Food Additives

• 1958 - Food Additive Amendment (Delaney Clause)
• requires that only those additives that dont
  cause cancer in man and in animals be Generally
  Recognized As Safe (GRAS list)
• absolute zero standard for carcinogenic additives
• additives that are toxic or allergens are not
  banned but require either warning labels or meet
  allowable threshold levels.
• Sulfites must be declared on label if above a
  given level

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Current Issues

• Switching prescription drugs to OTC status
• Effectiveness of labeling of OTC drugs
• Medications for special populations
• Reconsidering status of thaladomide
• Cohesive Food Policy
• Claims of Dietary Supplements
• Improved Inspection Procedures
• Irradiated Foods
• Genetically Altered Foods
• Biotechnology Food Labeling
• International Marketing