Biotechnology Regulations

1
Biotechnology Regulations

• Chapter 12

2
The Regulatory Framework

• U.S. Department of Agriculture
• Safe to Grow
• Environmental Protection Agency
• Safe for the Environment
• Food and Drug Administration
• Safe to Consume
• All 3 agencies work together!

3
U.S. Department of Agriculture

• Created in 1862
• Regulation of plant pests, plants and veterinary
  biologics (defined as any medical preparation
  made from living organisms or products (e.g.
  insulin and vaccines)
• Animal and Plant Health Inspection Service
  (APHIS) - Responsible for protecting U.S.
  agriculture from pests and diseases

4
U.S. Department of Agriculture

• Permitting Process
• Several years of field trials
• Petition for deregulation (plant pest
  consequences, risk to other organisms, weed
  consequences)
• Notification Process or fast track

5
The Environmental Protection Agency

• Established in 1970
• Experimental Use Permit (plants themselves must
  meet the same standards as chemical pesticides
  used in the fields)
• First one issued was to Advanced Genetic Sciences
  Inc. in 1985
• Next phase, deregulation and commercialization
  (considers the gene, its regulation, and the
  protein then health effects environmental fate,
  effect on non-targeted species)

6
Food and Drug Administration

• Consults with companies to produce safe products
• If a food or additive poses no foreseeable
  threat, it is granted generally-recognized-as-safe
  (GRAS) status (e.g. genetically engineered
  chymosin and BST)

7
Food and Drug Administration

• The Drug Approval Process
• GLPs regulations governing animal studies
• GCPs regulations governing human studies
• After animal trials- apply for Investigational
  New Drug status (IND)
• Phase I(safety)-20 to 80 healthy people
  determine ADME
• Phase II(efficacy)-100 to 300 patients
• Phase III- 1,000 to 3,000 patients in double
  blinded tests
• Only 20 make it to NDA
• EXCEPTION- fast track status to drugs that
  counter biological, chemical and nuclear
  terrorism and orphan drugs

8
Legislation and Regulation

• Philosophical values vs scientific evidence
• Stem Cell Research
• Labeling Biotech products

9
Introduction to Patents

• US Patent and Trademark Office (USPTO) issued the
  first patent on a bacterium in 1980
• Simple guidelines to protect a product
• Keep good records
• Do your homework

10
Introduction to Patents

• Novel
• Non-obvious
• Some Utility
• Patenting DNA Sequences
• Specific utility (what the sequence does)
• Substantial utility (real world use)
• Credible utility (sound science)

11
Biotechnology Products in the Global Marketplace

• The world community is still involved in
  preliminary negotiations
• UN voluntary code and a set of technical
  guidelines concerning the release of GMOs
• FAO focusing its attention on biotech in
  developing nations
• EU through the EMEA is the counterpart of the FDA
  (except it doesnt get involved in product
  development)

12
Ethics and Biotechnology

• Chapter 13

13
What is Ethics?

• It considers social and moral aspects and
  potential outcomes of the use of biological and
  medical techniques
• Ask yourself, Should this be done? and then
  How can it be done in the right way?

14
What is Ethics?

• Approaches To Ethical Decision Making
• The FIRST Hippocratic Oath-do not kill or to
  help or at least do not harm
• Two approaches
• Utilitarian or consequences-the ends justify the
  means
• Deontological or objectivism-there are at least
  some absolutes (definitive rules that cannot be
  broken)

15
What is Ethics?

• Ethical Exercise Warm-Up
• Should you push that guys in front of the car
  containing 3 children or not?

16
Biotechnology and Nature

• Asilomar Conference- called for a moratorium on
  DNA recombinant research until guidelines could
  be established

17
Biotechnology and Nature

• Cells and Products
• What are some of the ethical considerations
  associated with animal trials for human drugs?
• Safety
• Efficacy
• Humane treatment of animals in studies
• How many animals and which animal model? (e.g.
  thalidomide was originally tested in rodents and
  found safe however, after birth defects occurred,
  it was then tested in marmosets and birth defects
  occurred in the baby monkeys)

18
Biotechnology and Nature

• GM Crops Are You What You Eat?
• Areas of concern
• Do the alterations in the plant benefit it or at
  least do not produce a less vigorous plant?
• Is the integrity of the species maintained?
• Is the biodiversity of the species altered or the
  biodiversity of any insects dependent on this
  plant?
• What is the statistical probability of a bad
  event happening (e.g. transfer of the gene to
  another plant)?
• How safe is the new product? (e.g can humans
  become allergic to Bt?)
• What are the social and economic ramifications of
  introducing this plant? (e.g. farmers who recycle
  Roundup-Ready soybeans and therefore are stealing
  from Monsanto)

19
Biotechnology and Nature

• Animal Husbandry or Animal Tinkering
• Raises some of the some questions as in plant
  tinkering
• What are some of the early modifications?
  (antibiotics and hormone treatments)
• There is little concern about the effect of
  genetically modified ag animals on the
  environment, but is this appropriate? The effect
  on biodiversity?
• What about species integrity? Consider whether
  there is a point at which the animal might
  acquire enough human genes to be considered
  human? (what defines being a human?)

20
Biotechnology and Nature

• The Human Question
• Controversial issues surround the testing of
  drugs on humans, why?
• Who should get the drug (the sickest?)
• Why is informed consent so important-do you think
  parents should be allowed to decide for a child?
• The placebo problem in the double-blind test
  (someone is going to get a sugar pill)

21
Biotechnology and Nature

• What Does It Mean to Be Human?
• Current ethical debates revolve around the moral
  status of the human embryois it a human being?
• Does it qualify for personhood (defines an entity
  that qualifies for protection based not on an
  intrinsic value but rather on certain attributes
  such as self-awareness)
• AND what about the idea of creating embryos for
  an ES cell source vs spare or disregarded
  embryos?
• AND does creating embryos lead to human
  commercialization-making human life a commodity
  to be bought and sold?

22
Biotechnology and Nature

• Regulations in Flux
• Federal ban on federal funding of stem cell
  research has been reversed.

23
Biotechnology and Nature

• More or Less Human?
• What are the implications of germline genetic
  engineering? (Who decides what makes a better
  human being? What changes are allowed?)

24
Economics, The Role of Science, and Communication

• Grant funding is based on peer review