Federal Drug Laws Flashcards
HTS and UHTS (drug development)
High Throughput and Ultra High Throughput Screening
DART
Developmental and Reproductive Toxicity
NOEL
No Observed Effect Level (maximum level at which a toxic effect is not seen)
IND
Investigational New Drug application (submited to FDA to get permission for clinical trials)
Federal Food Drug and Cosmetic Act (FDCA, 1938)
Setup the FDA
Constrolled Substances Act (CSA, 1970)
Set laws regarding drugs of abuse and controlled substances. Overseen by the DEA, which was created three years later (1973)
Federal Food and Drug Act of 1906
Prohibited adultered and misbranded foods and drugs from interstate commerce
Federal Narcotic Drug Act of 1914 (Harrison Narcotic Act)
Made it illegal to sell or possess narcotics execpt in a tax stamped package
Durham-Humphrey Amendment of 1951 (Prescription Drug Amendment)
Created the notion of prescription drugs
Legend Drugs
Drugs that are required to have a label stating that they require a prescription
Kefauver-Harris Amendment (Drug Efficacy Amendment of 1962)
Manufactures must prove efficacy and safety of drugs, FDA would control prescription drug advertising and applications, mandated informed consent and AE reporting
Orphan Drug Act of 1983
Incetivized development of drugs for less profitable conditions
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act or Generic Drug Act)
Accelerated approval of generic versions, required demonstration of bioequivalence
Prescription Drug Marketing Act of 1987
Prevented retail sale of substandard/counterfit drugs, samples, re-imported drugs
Anabolic Steroids Control Act and Omnibus Budget Reconciliation Act of 1990 (OBRA)
Controlled anabolic steroids, made amendments to medicare/medicaid, denied reimbursement for unsafe/ineffective drugs, off-label prescribing
Prescription Drug User Fee Act of 1992 (PDUFA)
Made manufacturers pay user fees for new drug applications, resulted in decreased review time by FDA
FDA Modernization Act of 1997 (FDAMA)
Focused the FDA on including women and minorities more in clinical trials
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
Extended medicare to include prescription drugs
Combat Methamphetamine Epidemic Act of 2005
Regulates selling of ephedrine, pseudoephedrine and phenylpropanolamine (precursors to meth)
Biologics Price Competition and Innovation Act of 2009 (BPCIA)
Made law the concept of biosimilar for biologics drugs
Schedule 1 Drug
High abuse potential, no accepted medical use
Schedule 2 Drug
High abuse potential, current accepted medical use. Abuse may lead to dependence
Schedule 3 Drug
Some abuse potential, accepted medical use. Moderate or low potential for physical dependence and high potential for psychological dependence
Schedule 4 Drug
Accepted medical use, limited potential for dependence (Rx required)
Schedule 5 Drug
Accepted medical use, limited dependence possible (no Rx but sign log book)
What added steps are necessary for prescription of a controlled substance that are not necessary for prescription of a legend drug (regular prescription drug)?
1) DEA number of prescriber on prescription, 2) Prescription cannot be pre- or post-dated, 3) Label must have particular caution statement on it
FDA’s Orange Book
A publication of bioequivalent products (full name is Approved Drug Products with Therapeutic Equivalence Evaluations)
Bioequivalence
Equivalent release of the same drug substance
What is the difference between generic substitution and therapeutic substitution?
Therapeutic substitution involves swapping for a chemically different drug, whereas generic substitution involves swapping for a different product which is chemically the same drug (bioequivalent)
How do conflicting drug laws get resolved?
The more stringent law prevails (except in military or VA where federal law prevails)
