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Food and Drug Administration

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Food and Drug Administration. Drug Regulation. BIT 120. FDA ... 1927 Establish Food and Drug Administration. 1933 FDA sought to revise laws to include safety ... – PowerPoint PPT presentation

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Title: Food and Drug Administration


1
Food and Drug Administration
  • Drug Regulation
  • BIT 120

2
(No Transcript)
3
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 Shares responsibility
with clinicians and drug company
4
FDA
FDA federal science based law enforcement
agency 9000 employees scientists, MDs,
inspectors, others 1.2 billion budget
(4/taxpayer)
5
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

6
1906 Food and Drug Act regulates food, drugs
and cosmetics ensure proper labeling and product
unadulterated NOT DRUG SAFTEY 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
7
Sulfanilamide
  • 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
8
Issues
Should drugs be available prior to completion of
testing? HIV Needs of few vs many Cancer How
Safe should drug be? Risk assessment Risk vs
Reward Short term effects Long-term effects
(withdrawal of a drug) Education of patient
9
Approval
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)

10
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
11
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 lt200,000 patients No
cure or treatment Difficult to get patients for
clinical trials
SEE HANDOUT
12
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)
13
When recombinant version of approved protein is
re-evaluated...
Chymosin 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
14
Tryptophan
Contaminated Batches caused by Enhanced
bacterial strain Change in purification Caused
EMS (eosinophilia-myalia syndrome) muscle
pain respiratory arrest
15
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
16
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

17
References
Biotechnology Demystifying the Concepts Pages
230-231 306-310 Pharmaceutical Research and
Manufacturers of America- Publications (www.phrm
a.org/publications) Bio-link.org Molecular
Biotechnology Glick and Pasternack
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