Lect 2 Regs of Medications Flashcards
Pure food and drug act of 1906
- brought on by Upton Sinclair’s “The Jungle”
- Prohibited the adulteration and misbranding of food/meds
- Amended in 1912, prohibit false efficacy claims
Sulfanilamide Elixir
- circa 1937, Massengil reported a demand for liquid form of drug
- diethylene glycol solvent was used
- 107 deaths (renal failure and seizures)
Food, Drug, and Cosmetic act of 1938
- no new drug could be marketed until proven safe for use and approved by FDA
- labels must contain adequate directions and warnings
- pre1938 drugs exempt
Roles of FDA
- Rulemaking
- Issue guidance documents
- Incorporate advice from standing advisory committees of outside experts
Durham-Humphrey Amendment of 1951
- Established 2 classes of drugs (OTC and RX)
- RX: those that required medical supervision and a warning “caution, federal law prohibits dispensing w/o rx”
- OTC:do not require medical supervision (still need labeling)
- Authorized oral scripts/refills
Thalidomide Tragedy of 1961
- sleep aid and antiemetic for morning sickness
- Dr. Frances Kelsey had concerns
- 10,000 flipper babies
Thalidomide Today
- in 2006, approved for multiple myeloma (w/dexamethasone)
- only dispensed under STEPS
- available only to approved professionals
REMS programs
-Risk evaluation and mitigation tool CAN include: -distribution of a medication guide -Registries -Provider training
Kefauver-Harris Amendment of 1962
- AKA drug efficacy amendment
- required drugs to be proven safe and effective to be approved
- transferred rx drugs advertising from FTC to FDA
- established GMPs
- required informed consent and ADR reporting
Orphan drug act of 1983
-provided tax and license incentives for manufacturers who developed drugs for rare diseases/conditions (<200K)
Wax Hatchman Amendment
- AKA drug price competition and patent term restoration act of 1984
- streamlined the generic drug approval process while giving patent extensions for innovative drugs
Prescription drug marketing act of 1987
- in repsonse to diversionay distribution systems
- required restrictions and recordkeeping for samples
- prevented medical centers from reselling stock
- required licensing of drug wholesalers
Patient protection and ACA of 2010
- mandate all individuals have health insurance
- set up exchanges for companies to compete
- phase out donut hole
- stop brand/generic collusion
What is a drug?
- article in the USP/NF
- article intended to diagnose, cure, mitigate, treat, or prevent disease
- article intended to affect structure or function of the body
Special food categories
Legal categories -special dietary foods -medical foods Publicly conceived categories -Nutraceuticals -functional foods
Class I recall
Reasonable probability product will cause serious health consequences or death (heparin 2008)
Class II recall
Product may cause temporary or reversible adverse effects (Ketorolac 2010)
Class III recall
Product unlikely to cause adverse health consequences
Adulteration
1) consists of any filthy, putrid, or decomposed substances
2) represented as the drug not recognized in USP. wrong strength, or quality/purity below USP standards
3) mixed or packed therwith so as to reduce quality/strength
Federal Anti-tampering act
Act requires certain OTC drugs, cosmetics, and devices be manufactured in tmaper resistant packaging
Misbranding
- label can’t be false/misleading
- label must include active ingredients (in alpha)
- adequate directions for/warnings against use
- cannot imitate another drug
Adulteration vs Misbranding
A:deals with drug’s strength, purity, and quality
M: focuses on representations made by the manufacturer on the label
Pregnancy A
Adequate studies have not demonstrated a risk to fetus
Pregnancy B
Animal studies failed to demonstrate risk to fetus
