Term
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Definition
| AA women refuse to move to colored car- separate but equal & doesn't violate 13th amendment-held for 58 years until Brown v. Board of Education |
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Term
| Ferguson v. Williams 1991 |
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Definition
| In NC - patient had allergies to ASA/Percodan and RPh knew and filled Indomethacin --Pt died of anaphylaxis. Court says RPh has no duty to warn about dangers & liability for RPh even though no duty |
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Term
| Cohen v. Missouri Board of Pharmacy 1998 |
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Definition
| Complaint that person stole 400 Vicodin tablets from pharmacy and revoked RPh's license because he let it happen |
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Term
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Definition
| Negligence of approving chemo with 23.4% sodium chloride instead of 0.9% sodium chloride and patient died |
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Term
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Definition
| Inmates petitioned use of drugs for lethal injection. They petitioned the Food and Drug Administration (FDA), alleging that use of the drugs for such a purpose violated the Federal Food, Drug, and Cosmetic Act (FDCA), and requesting that the FDA take various enforcement actions to prevent those violations. |
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Term
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Definition
| Lance Chaney, was found guilty of possession of a controlled substance, sentenced to one year probation, fined $50 for laboratory fees and assessed a $5 monthly probation fee. |
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Term
| Pure Food and Drug Act 1906 |
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Definition
| Prohibits misbranding-requires drugs to meet standards-Mother's Little Helper(morphine) |
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Term
| Food and Drug Act of 1938 |
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Definition
| Sulfanilamide (diethylene glycol) response-requires drugs to be SAFE and approved by FDA |
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Term
| Durham-Humphrey Amendment of 1951 |
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Definition
| Establishes OTC (non-legend) and Rx (legend) drug classes and prohibits legend drugs from being dispensed without prescription |
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Term
| Drug Efficacy Amendment 1962 (Kefauver) |
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Definition
| Thalidomide- must be proven SAFE and EFFECTIVE- establishes GMP, advertising, clinical investigations |
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Term
| Medical Device Amendments 1976 |
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Definition
| Dalkon Shield -need pre-market approval, GMP conformance and classification of devices |
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Term
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Definition
| Incentives for manufacturers to create products for diseases affecting less than 200,000 American |
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Term
| Waxman Hatch Amendment 1984 |
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Definition
| Allows ANDA process without safety or efficacy-enhances protection for innovators-greater generic competition |
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Term
| Prescription Drug Marketing Act 1987 |
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Definition
| Restricts samples, encouraged ped. drug studies, expands FDA authority over OTCs |
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Term
| Dietary Supplement Health and Education Act 1994 |
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Definition
| FDA regulates dietary supplements-prove DS is unsafe before it is removed from market |
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Term
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Definition
| DS manufacturers fought pre-marketing approval requirements of FDA since they claimed that FDA violated 1st amendment rights (commercial free speech) |
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Term
| Prescription Drug Fee User Act 1992 |
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Definition
| Manufacturers pay fees for FDA reviews to speed up process of approval |
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Term
| UF v. Guardian Chemical Company 1969 |
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Definition
| Product not only cleans dairy apparatus but dissolves kidney/bladder stones- FDA says product is a drug and must conform to labeling rules-Ruling must conform to label rules |
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Term
| Food, Drug and Cosmetic Act (FDCA) Section 301 |
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Definition
| Prohibits misbranded or adulterated food, drug, device or cosmetic-including alterations, counterfeits, refusal of inspection |
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Term
| FDA Rating and Classification System 1974 |
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Definition
Number (chemical) system - 1. new molecular entity 2. new salt/ester 3. new dosage form 4. new combo 5. generic 6. new indication
Letter (Therapeutic) - P rating- Therapeutic advance & S rating- similar therapeutic properties as similar drugs |
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Term
| Drug Efficacy Study Implementation (DESI) |
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Definition
| Kefauver requires drug (post 1938) to be effective and post 1962 generics are new drugs |
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Term
| National Academy of Science and DESI |
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Definition
| Responsible for 1938-1962 drugs - efficacy categories 1. Effective 2. Probably effective 3. Ineffective 4. Effective but... 5. Ineffective as combo product |
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Term
| USV pharma Corp. v. Weinberger 1973 |
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Definition
| Manu. sells bioflavanoid products with hematologic/capillary fragility effects - no evidence to well controlled investigation - NDA withdrawn - FDA has authority to determine if drugs are new and subject to efficacy review |
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Term
| Hoffman La-Roche v. Weinberger 1975 |
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Definition
| Innovator sues over generic version marketed without approval. Brand name manufacturers amendment enforces to limit generic competition- FDA cannot allow unapproved products to be marketed |
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Term
| Drug Price Competition and Patent Term Restoration Act |
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Definition
| Generic companies get speedier approval- Manufacturers must present Cmax, AUC, 90% CI, 0.80-1.25 BE between products |
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Term
| Bristol Myers Squibb Co. V. Shalala 1996 |
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Definition
| Innovator sought new indication which gives them 3 year extension on market - Generic product must be safe and effective for each indiction on its label - FDA allows ANDA for generics |
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Term
| United States v. Rutherford 1979 |
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Definition
| Patients and spouses to enjoin FDA from halting intersate shipment of Laetrile- Supreme court- court of appels is wrong- safety and efficacy are important to all drugs, regardless of patient health status |
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Term
| Abigail Alliance Decision |
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Definition
| Abigail Burroughs diagnoses with squamous cell carcinoma of head and neck- applies for clinical trial and is rejected-drugs later approved- Court of Appeals-patients have protected liberty interest under Due Process and when drug in Phase II when no approved alternative is available |
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Term
| Medical Device Amendments of 1976 |
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Definition
Class I -needles, gloves, toothbrushes
Class II-syringes, infustion pumps, heating pads, tampons
Class III - Implants,pacemakers, stents, valves, contact lenses, pre-1976 products (Grandfather clause) |
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Term
| FDA Modernization Act 1997 |
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Definition
| Durham-Humphrey Amendment - First statutory distinction between legend and on-legend medications- |
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Term
| US v. Article of Drug-Decholin 1967 |
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Definition
| FDA must prove two issues to change the status of drug- 1. Toxicity & 2. Collateral measures (harm) |
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Term
| Switching Prescription Drugs to OTC Drugs |
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Definition
1. Manu. requests switch with supplemental applications to approved NDA:change will only apply to manu's product
2.Manufacturer petitions FDA
3.Drug switched through a drug review process |
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Term
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Definition
| FDA require patient package inserts for estrogens- COngress wants FDA input and there is no interference with patient-physician relationship |
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Term
| 1992 Compliance Policy Guide |
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Definition
| FDA historically sides with manufacturers who don't want compounding to exists |
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Term
| Food and Drug Modernization Act 1997 |
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Definition
Rescinds 1992 guide- compounding ok for 1. individual patient 2. not a copy of existing product
No solicitying compounded Rxs or advertising compounding of certain |
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Term
| Thompson v. Western States Medical Center 2002 |
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Definition
| Food and Drug Modernization Act of 1997’s prohibitions on soliciting prescriptions and advertising of compounded drugs amounts to unconstitutional restrictions on commercial speech |
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Term
| 2002 Compliance Policy Guide |
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Definition
| Compounding in anticipation, withdrawn products, unapproved bulk products, commercial scale equipment, compounding for re-sale |
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Term
| Medical Center Pharmcy v. Gonzalez 2006 |
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Definition
| Invalidated 2002 guide- compounding is lega, are not new drugs, in anticipation must be reasonable, can be advertised |
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Term
| Prescription Drug Marketing Act |
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Definition
| States must licence wholesalers, re-importation is banned, bans sales, trade and purchases of samples, prohibits resales to other healthcare entities |
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Term
| Poison Prevention Packaging Act |
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Definition
| Enforced by Consumer Product Safety Commision, child resistant caps |
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