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Food and Drug Administration
Drug Regulation
BIT 120
Regulatory body that governs testing and marketing of new
therapeutic drugs, food, medical devices and procedures
Establishes guidelines for how drugs should be tested in
animal studies, as well as clinical trials
Shares responsibility with clinicians and drug company
FDA – federal science based law
enforcement agency
9000 employees – scientists, MDs,
inspectors, others
$1.2 billion budget ($4/taxpayer)
FDA Mission
• Foods are safe, wholesome, sanitary and
properly labeled
• Human and veterinary drugs are safe and
• Safety of devices intended for human use
• Public health and safety are protected from
• Cosmetics safe and properly labeled
1906: Food and Drug Act
regulates food, drugs and cosmetics
ensure proper labeling and product unadulterated
1927 Establish Food and Drug Administration
1933 FDA sought to revise laws to include safety
eyelash dye- caused blindness
cream- mercury poisoning
weight loss drugs - death
1938: Revised Food, Drug and Cosmetic Act passed
included drug safety (animal and clinical studies)
and efficacy
•Sold by Massengill
•Pill ‘solubilized’ in diethylene glycol ELIXIR
•350 poisonings, 100 deaths
Pulled from shelves because mislabeled
- NOT an elixir
Massengill not held responsible for poisoning
Should drugs be available prior to completion of
Needs of few vs many
How Safe should drug be? Risk assessment
Risk vs Reward
Short term effects
Long-term effects (withdrawal of a drug)
Education of patient
FDA reviews application
10-15% are denied
FDA decides whether RAC needs to review
Recombinant DNA Advisory Committee
•reviews applications to use novel recombinant
DNA procedures
(ie Gene Therapy)
•part of NIH (National Institutes of Health)
•must publish meeting minutes for public view
•no release of GEO to environment (originally)
Where does FDA look for
1. During Pre-Clinical Studies
lab and animal studies
2. Clinical Trials
3. During NDA review
4. Post-Marketing
Orphan Drug Act
Orphan diseases affect
<200,000 patients
No cure or treatment
Two incentives:
1) 7- year period of market
exclusivity following approval
of drug by FDA
2) 50% tax credit for clinical
research expenses
Difficult to get patients for
clinical trials
Early Regulations on rDNA Tech
A. 1973 Self-Imposed Moratorium
On Recombinant DNA experiments until
regulatory guidelines established
recombinant microorganisms proliferate outside laboratory?
Potential hazard to lab workers?
B. 1976 US National Institutes of Health
1. primary research grant agency for medical and health sciences
2. no legal status
3. issues guidelines
containment of organisms (i.e., negative pressure rooms)
(Later data shows that E coli K 12 strain unable to extensively live
outside lab)
When recombinant version of approved
protein is re-evaluated...
cheese making
cows stomach
hydrolyzes casien in milk
Is rChymosin the same as naturally derived?
Restriction mapping
DNA hybridization
DNA sequencing
molecular weight
biological activity
Purification - remove E coli contaminants
Contaminated Batches caused by
Enhanced bacterial strain
Change in purification
Caused EMS (eosinophilia-myalia syndrome)
muscle pain
respiratory arrest
Recombinant Bovine
Arguments for
1. more milk/less cows
2. Levels of bST in milk no higher than control cows
3. bST no adverse reaction in humans
Arguments against
1. Antibiotics given due to infection of milk glands
causing allergic reaction
2. economic consequences
little farmer put out of business
Release of GEO
1983 Submissions made to NIH-RAC
1. Submission announced to US Federal Register
2. Information disseminated
3. Reviewed by panel of experts
4. Public Meeting
5. Review by USDA (U.S. Dept of Agriculture)
After lawsuit to block use of ice-minus bacteria…
Responsibility of GEO release went to
•EPA (Environmental Protection Agency)
Biotechnology: Demystifying the Concepts
Pages 230-231
Pharmaceutical Research and Manufacturers of AmericaPublications
Molecular Biotechnology Glick and Pasternack