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MPJE - Federal
Federal Laws and Regulations
| Term | Definition |
|---|---|
| Subsidiaries of HHS | Food & Drug Administration (FDA) Centers for Disease Control (CDC) Centers for Medicare and Medicaid Services (CMS) |
| Subsidiary of DOJ | Drug Enforcement Administration (DEA) |
| FDA Drug Approval Process | INDA: P1 = animal studies to determine safety, adverse effects, PK/PD; P2= larger animal studies ~100 with disease or condition to determine safety, efficacy, dosage; P3= >1000 people, compared against placebo./SOC; NDA:P4 = Post-market surveillance |
| Abbreviated New Drug Application (ANDA) | Same active ingredient, Route of administration, dosage form, strength, and bioequivalence |
| FDA Classification of New Drugs | Type P- Priority: advance in therapy compared to currently marketed drugs Type S- Standard: similar therapeutic qualities as marketed drugs |
| Pure Food and Drug Act (Wiley Act) - 1906 | Prohibited adulteration or misbranding of food and drugs Drug ingredients did not have to be listed Cosmetics and devices not regulated |
| Adulteration | If it consists in whole or in part of any filthy, putrid or decomposed substance; or if it has been prepared, packed, or held under any unsanitary conditions whereby it may have been contaminated or may have been rendered injurious to health |
| Misbranding | If a product's labeling is false or misleading and sold, dispensed, or distributed in violation of the labeling requirements of the FD&C Act |
| Food, Drug, and Cosmetic Act - 1938 | New drugs to be proven safe for labeled indication Regulates cosmetics & devices Created the FDA & NDA approval process Labeling for "adequate directions" and habit forming meds Drugs marketed prior to 1938 were grandfathered in Created USP, NF, HPUS |
| Durham-Humphrey Amendment - 1951 | Amends the FD&C Act Creates Rx Only & OTC categories Allowed verbal orders and transcription of the prescription Allowed refills of prescriptions |
| Food Additives Amendment (Delaney Clause) - 1958 | Premarket approval for food safety Food additives were prohibited if shown to induce cancer in humans or animals |
| Color Additive Amendment - 1960 | Required manufacturers to ensure safety for color additives to foods, drugs, and cosmetics |
| Kefauver-Harris Amendment - 1962 | Amends the FD&C Act Drugs marketed after 1962 must be both safe & effective Informed consent for human research Established cGMP for all drugs and DESI for drugs 1938-1962 FDA oversight of drug advertising FTC oversight of OTC and dietary supplements |
| Medical Device Amendment - 1976 | Amends the FD&C Act Medical devices are classified by specific function - record keeping and adverse event reporting Manufacturers must follow cGMP (Current Good Manufacturing Practices) |
| Orphan Drug Act - 1983 | Treatment of rare disease and conditions - < 200,000 people Incentivized manufacturers to develop and market orphan drugs 50% tax credit on clinical testing 7 year exclusivity |
| Hatch-Waxman Amendment (Drug Price Competition and Patent Term Restoration Act) - 1984 | Amends the FD&C Act Brand patent protection = 5 years Established therapeutically equivalent generics; must have BE Established use of ANDA & Orange Book |
| Prescription Drug Marketing Act - 1987 | Wholesalers must be licensed under state jurisdiction Bans sale of drug samples Prohibits re-importation of drugs Transfer by sale from an institution to a community pharmacy (in an emergency) |
| Safe Medical Devices Act - 1990 | Increased FDA authority in medical devices Established post-market requirements and pre-market notification and approval process |
| Nutrition Labeling and Education Act - 1990 | Health claims were regulated for food products Authorizes health claims (in compliance) on product labeling |
| Generic Drug Enforcement Act - 1992 | Imposed debarment (exclusion) and other penalties for illegal acts involving the ANDA process (false statements, bribes, disclosure failures) Resulted from series of incidents of FDA staff taking bribes |
| Prescription Drug User Fee Act - 1992 | Added fees to increase revenue and FDA resources (including staff) to address drugs and biologic application reviews |
| Dietary Supplement Health and Education (DSHEA) Act - 1994 | Prohibited adulteration and misbranding Health claim- nutrient deficiency, support health, or be linked to body functions "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease" |
| FDA Modernization Act (FDAMA) - 1997 | Replaced the PDUFA -1992 Established fast track NSA process for life-threatening diseases Simplified labeling requirement to 'Rx only" established clinicaltrials.gov and pediatric testing for pediatric drugs |
| FDA Amendments Act of 2007 | Established Risk Evaluation and Mitigation Strategy (REMS) FDA established five levels of mitigation: Professional label and package insert, REMS MedGuide, REMS communication plan, ETASU, implementation system (open, managed, controlled, restricted) |
| Biologics Price Competition & Innovation Act - 2009 | Established biosimilar and interchangeable of biologic products Established biosimilar approval process |
| FDA Safety and Innovation Act - 2012 | Blocks adulterated products from entering drug marketplace (counterfeits) Improves drug diversion information sharing between states |
| Drug Quality and Security Act - 2013 | Increased oversight in larger scale compounding and sterile products Regulated outsourcing facilities- large volume sterile products, interstate transactions allowed, orders don't require individual prescriptions Drug product track & trace |
| Right to Try Act - 2018 | Improved access to investigational medications (life-threatening condition, exhausted approved options, written informed consent from physician) Immunity protection for manufacturers and study sponsors |
Created by:
skelly46
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