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Food and Drug Administration. Drug Regulation BIT 120. FDA. 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

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food and drug administration

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
FDA Mission
  • Foods are safe, wholesome, sanitary and properly labeled
  • Human and veterinary drugs are safe and effective
  • Safety of devices intended for human use
  • Public health and safety are protected from radiation
  • 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

  • Antibiotic
  • 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 testing?


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

  • RAC
  • 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 safety
Where does FDA look for Safety?

1. During Pre-Clinical Studies

lab and animal studies

2. Clinical Trials

3. During NDA review

4. Post-Marketing

orphan drug act
Orphan Drug Act

Two incentives:

1) 7- year period of market exclusivity following approval of drug by FDA

2) 50% tax credit for clinical research expenses

Orphan diseases affect <200,000 patients

No cure or treatment

Difficult to get patients for clinical trials


early regulations on rdna tech
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
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 somatotropin
Recombinant Bovine Somatotropin

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
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)
        • USDA

Biotechnology: Demystifying the Concepts

Pages 230-231


Pharmaceutical Research and Manufacturers of America-



Molecular Biotechnology Glick and Pasternack