Landmark drug legislations in the US:
1. The first American aw to regulate drugs was the Federal Pure Food and Drug Act of 1906
- this law was very weak: it required only that drugs be free of adulterants; nothing about safety or effectiveness
2. The Food, Drug and Cosmetic Act (1938) was must stronger and was the first legislation to address drug safety; must be Food and Drug Administration (FDA) approved to market
3. the Harris-Kefauver Amendments (1962) required drugs be EFFECTIVE before marketing; this law also required rigorous procedures for testing new drugs
4. the controlled substances act (1970) set rules for the manufacture and distribution of drugs considered to have potential for abuse
the development and testing of new drugs is an expensive and lengthy process, requiring 6-12 years for completion.
cost of developing a new drug can exceed $800 million.
Randomized controlled trials (RCTs) are the most reliable way to objectively assess drug therapies. RCTs have 3 distinct features: use of controls, randomization, and blinding.
- 1. use of controls: controls allow us to compare the safety of the new drug with that of the old drug, a placebo, or both
- 2. Randomization: by assigning subjects randomly to the control and experimental groups, all factors - known and unknown, important and unimportant- should be equally represented in both groups
- 3. blinding: done to minimize the impact of personal bias
Stages of new drug development:
2 principle steps: preclinical testing and clinical testing
Preclinical testing is required before a new drug may be tested in humans.
drugs are evaluated for toxicities, pharmacokinetic properties and potentially useful biologic effects.
may take 1-5 years.
when sufficient preclinical data have been gathered, the drug developer may apply to the FDA for permission to begin testing in humans
if the application is approved, the drug is awarded Investigational New Drug status and clinical trials may begin
- clinical testing
- occurs in 4 phases and may take 2-10 years.
- the first 3 stages are done before a new drug is marketed and the fourth is done after
- phase 1: usually conducted in healthy volunteers unless the drug is likely to have severe side effects, then its done in volunteer patients who have the disease under consideration
- this phase has 3 goals: evaluating drug metabolism, pharmacokinetics and biologic effects
- phase II and III: drugs are tested in patients
- objective is to determine therapeutic effects, dosage range, safety and effectivenss
- upon completing phase III, the drug manufacturer applies to the FDA for conditional approval of a New Drug Application
Phase IV: postmarketing survellance
The 3 types of Drug Names:
1. chemical name: constitutes a description of a drug using the nomenclature of chemistry
2. Generic Name: assigned by the US Adopted Names Council. each drug only has ONE generic name. aka the nonproprietary name or the US adopted name.
3. trade name: aka proprietary or brand names. these are the names under which a drug is marketed. must be approved by the FDA
- 1. N-acetyl-para-aminophenol
- 2. acetaminophen
- 3. tylenol
Sources of Drug Info:
People - clinicians and pharmacists, poison control centers, pharmaceutical sales reps
Published Info - text-like books, newsletters, reference books, and the internet
since the job of the drug rep is sales and not education, this person may not be your best source of drug info
as pharm students, you should know that Goodman & Gillman's The Pharmacological Basis of Terapeutics (aka G&G) is the classic text/reference on pharmacology