| pioglitazone | Actos
Antidiabetic agent |
| glyburide | Diabeta
Antidiabetic agent |
| metformin | Glucophage
Antidiabetic agent |
| glipizide | Glucotrol
Antidiabetic agent |
| insulin lispro | Humalog
Antidiabetic agent |
| sitagliptin | Januvia
Antidiabetic agent |
| insulin glargine | Lantus
Antidiabetic agent |
| insulin detemir | Levemir
Antidiabetic agent |
| insulin aspart | Novolog
Antidiabetic agent |
| saxagliptin | Onglyza
Antidiabetic agent |
| liraglutide | Victoza
Antidiabetic agent |
| meclizine | Dramamine/Antivert
Antiemetic |
| metoclopramide | Reglan
Antiemetic |
| ondansetron | Zofran
Antiemetic |
| ranitidine | Zantac
Gastric antisecretory agent (H2RA) |
| famotidine | Pepcid
Gastric Antisecretory Agent (H2RA) |
| rabeprazole | Aciphex
Gastric antisecretory agent (PPI) |
| dexlansoprazole | Dexilant
Gastric antisecretory agent (PPI) |
| esomeprazole | Nexium
Gastric antisecretory agent (PPI) |
| lansoprazole | Prevacid
Gastric Antisecretory Agent (PPI) |
| omeprazole | Prilosec
Gastric Antisecretory Agent (PPI) |
| pantoprazole | Protonix
Gastric Antisecretory Agent (PPI) |
| dicyclomine | Bentyl
GI Antispasmodic for IBS |
| loratadine | Claritin
Anti-Allergy Agent |
| fexofenadine | Allegra
Anti-Allergy Agent |
| cetirizine | Zyrtec
Anti-Allergy Agent |
| promethazine | Phenergan
Anti-Allergy Agent/Antiemetic |
| fluticasone | Flonase
Nasal Anti-Allergy Agent |
| mometasone | Nasonex
Nasal Anti-Allergy Agent |
| olopatadine | Patanol
Topical Anti-Allergy Agent |
| albuterol | ProAir HFA/Ventolin
Anti-asthmatic |
| budesonide | Pulmicort
Anti-asthmatic |
| tiotropium | Spiriva
Anti-asthmatic |
| risedronate | Actonel
Osteoporosis Agent |
| alendronate | Fosamax
Osteoporosis Agent |
| raloxifene | Evista
Osteoporosis Agent |
| allopurinol | Zyloprim
Uric Acid Reducer |
| colchicine | Colcrys
Uric Acid Reducer |
| travoprost | Travatan
Anti-Glaucoma Agent |
| latanoprost | Xalatan
Anti-Glaucoma Agent |
| Are laws made in anticipation of problems? | No, typically in response to a problem |
| When state and Federal laws conflict | we follow the strictest law |
| First U.S. Pharmacopoeia (USP) was published | 1820 |
| National Formulary NF Created | 1888 |
| Congress passed Pure Food and Drug Act in 1906
A.K.A. “The Wiley Act”
Prohibited foods and drugs to be adulterated or misbranded
First time that drugs were recognized as requiring laws and regulation | Pure Food and Drug Act of 1906 |
| Crime to label drugs with false and fraudulent claims of therapeutic effectiveness
Required a prosecutor to prove a deliberate intent to defraud the public | 1912 – Sherley Amendment |
| Regulated opium, coca, and their derivatives
Ensured orderly marketing of narcotics
Now illegal to purchase certain “cure-alls” – needed prescription for products that exceeded certain limits of narcotics
Required record keeping
Could not prescribe opiates to addicts to maintain addiction
Thousands of physicians imprisoned | Harrison Narcotics Act of 1914 |
| Liver and kidney damage
Approximately 105 deaths, mostly children
Contained 72% diethylene glycol (anti-freeze) | 1937 – Elixir of Sulfanilamide |
| In response to the Elixir of Sulfanilamide tragedy
Required all new drugs to be proven safe before going on market
Required that labels have adequate direction for use
Warnings about habit-forming drugs that are contained in product
Included cosmetic products and medical devices | Food, Drug and Cosmetic Act of 1938 |
| Drug products marketed before 1938 were exempted
A new department was created - Food and Drug Administration (FDA)
New Drug Application (NDA) must be submitted | Food, Drug and Cosmetic Act 1938 |
| Many drugs still not safe to use without medical supervision
Durham-Humphrey Amendment established two classes of drugs
Legend drugs (prescription)
Nonprescription Over-the-Counter (OTC) | Durham-Humphrey Amendment of 1951 |
| 1950s and 1960s – thalidomide common treatment for morning sickness
Sold in 46 countries (not U.S.)
Found to cause serious birth defects
10,000 babies born with phocomelia | Thalidomide Tragedy |
| The absence of most of the arm with hands extending from the shoulders
Similar with legs and feet
Phocomelia can be the result of a single dose of thalidomide
1962 – banned in most countries | Phocomelia |
| Adopted after the thalidomide tragedy
Amendment to the Food, Drug and Cosmetic Act
AKA the Drug Efficacy Amendment
Drugs need to be effective as well as safe
FDA was given authority to regulate the advertising of prescription drugs | Kefauver-Harris Amendment of 1962 |
| Required informed consent for subjects in clinical investigations
Reporting adverse drug reactions
Creation of Good Manufacturing Practice requirements
OTC advertising regulated by the Federal Trade Commission, not the FDA | Kefauver-Harris Amendment 1962 |
| Amendment to the FDCA
Better classification of medical devices according to their specific functions
Established performance standards for devices
Pre-market approval requirements
Conformance with GMP standards | Medical Device Amendment of 1976 |
| Poisoning by common household substances leading cause of injuries among children under 5
Child resistant packaging for hazardous household products
OTCs – one size can be non-safety cap
“This package for households without young children”
Waiver for patients in the pharmacy | Poison Prevention Packaging Act of 1970 |
| Passed after the Tylenol murders
7 deaths - victims of product tampering
Extra-strength Tylenol capsules in question found to contain 65mg of cyanide
In addition to the 5 bottles that caused 7 deaths, 3 more bottles were also discovered that were contaminated
Never been solved | Anti-Tampering Act of 1982 |
| Orphan drugs – drugs used to treat rare diseases – affecting less than 200,000 people
Manufacturers reluctant to develop – low potential for profitability – high cost to manufacture
Orphan Drug Act enacted to facilitate the development of orphan drugs
Tax breaks, subsidies, monopoly privileges | Orphan Drug Act of 1983 |
| A.K.A. the 1984 Hatch-Waxman Act
Streamlined drug approval process for generics
Only need to submit abbreviated new drug application (ANDA)
Only required proof of bioequivalence | 1984 –Drug Price and Patent-Term Restoration Act |
| Prescriptions drug wholesalers must be licensed by states under federal guidelines
Banned re-importation of prescription drugs produced in the U.S.
Banned sale, trade or purchase of prescription drug samples – record keeping required
Resale of prescription drugs prohibited by hospitals, with certain exceptions | Prescription Drug Marketing Act of 1987 |
| Fast-track approvals for drugs that treat serious conditions
States will regulate compounding – pharmacies exempt from GMP standards
“Rx Only” replaces old legend
Encouraged marketing for “unapproved uses”
Pediatric studies incentives – six month marketing exclusivity | FDA Modernization Act of 1997 |
| Medicare Part D – prescription drug coverage – began January 1, 2006 | Medicare Prescription Drug Improvement, and Modernization Act of 2003 |
| Major bill passed by Congress
Required that all individuals have health insurance – Health Insurance Exchange was created
Stop agreements between brand name and generic drug manufacturers that limit or delay competition from generic drugs
Phase elimination of the catastrophic threshold, or “donut hole” or “coverage gap”, during which the patient pays all costs of Rx drugs | Patient Protection and Affordable Care Act of 2010 |
| Part of the Affordable Care Act
Well-woman visits
Gestational diabetes screenings
STD counseling
HIV counseling and screening
Contraceptive counseling
Etc. | Women’s Preventative Health Care Amendment of 2012 |
| END | END |
