Pure Food and Drug Act (1906)
-Passed by congress
-Prohibited adulteration and misbranding of foods and drugs in interstate commerce
US V. Johnson
-1911 US Supreme Court decision
-Held that misbranding provision in the law did not prevent false or misleading efficacy claims
-1912 - Congress amended the Pure Food and Drug Act to prohibit false claims and fraudulent efficacy claims
-Difficult to prove
Sulfanilamide tragedy
-1937- an elixir made with diethylene glycol solvent without any prior toxicity tests
-FDA had no authority to ban unsafe drugs, so it removed the drug on technical misbranding violation since elixirs must contain alcohol
Food, Drug, and Cosmetic Act of 1938
-Required that no new drug could be marketed until it was proven safe to be used under the conditions described on the label and approved by the FDA
-Applies to devices
-Drugs before 1938 exempt
-Applies to interstate commerce and transactions between pha
Durham Humphrey Amendment 1951
-Established prescription and OTC classes
-Provided that labels of Rx do not require adequate directions for use if they contain the legend
-Directions from prescriber on label satisfy adequate directions for use
-Authorizes oral Rx and refills of Rx drug
Food Additives Amendment (1958)
-Required that components added to food products receive premarket approval for safety
-Delaney clause prohibited approval of any food additive that might cause cancer
Color Additive Amendment of 1960
Required that manufacturers establish the safety of color additives in food, drugs, and cosmetics
Kefauver-Harris Amendment of 1962
-Required that drugs be roved safe and effective
-Effectiveness requirement retroactive to all drugs marketed between 1938 and 1962
Medical Device Amendments of 1976
-Public safety concerns with devices such as Dalkon Shield, an IUD, prompted congress to add regulation, administrative authority, and premarket approval for the safety and efficacy of medical devices
Orphan Drug Act of 1983
- Congress passed act to provide tax advantages and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of rare diseases (less than 200,000)
Drug Price Competition and Patent Term Restoration Act of 1984
-Act provided patent extension in some cases to innovator drugs
-Intent was to make generic drugs more readily available to the public and to provide incentives for manufacturers to develop new drugs
Safe Medical Devices Act of 1990
-Act gave the FDA additional authority related to post-marketing requirements and pre-market notification and approval of medical devices, while expediting the pre-market device approval process
Generic Drug Enforcement Act of 1992
-FDA staff accepted bribes from generic to facilitate approval of generics
-FDA can ban individuals or firms from participating in drug approval process if convicted of related felonies
-Imposed severe civil penalties for false statements, bribes, failure
Prescription Drug User Fee Act of 1992
-Act required private industry to shoulder part of the costs for reviewing new drugs in the FDA
-ACT must be reauthorized every five years
Nutrition Labeling and Education Act of 1990
-Requires nutrition labeling on food products and authorizes health claims on product labeling, so long as the claims are made in compliance with FDA regulations
Dietary Supplement Health and Education Act of 1994
-Act forced the FDA to regulate dietary supplements more as foods than as drugs
-Define dietary supplements and permit manufacturers to make certain claims that otherwise would have been illegal under the FDCA
Food and Drug Administration Modernization Act of 1997
-Creates fast-track approval process for drugs intended for serious or life-threatening diseases
-Establishes a data bank on clinical trials
-Authorizes scientific panels to review clinical investigations
-Expands the rights of manufacturers to disseminat
FDA Amendments Act of 2007
-Allows the FDA broader use of the fees generated from the Prescription drug user fee act, while substantially increasing the fees
-FDA with enhanced responsibilities and authorization to regulate drug safety, including the authority to mandate labeling c
FDA Safety and Innovation Act of 2012
-Reauthorized PDUFA
-Allows FDA to continue to collect user fees from manufacturers seeking NDA or medical device approvals
-Adds new user fees for generic drugs and biosimilars
Drug Quality and Security Act of 2013
-Passed in response to meningitis outbreak caused by contaminated drugs compounded by New England Pharmacy
-Adds track-and-trace requirements for all entities in the chain of distribution of pharmaceutical products
-Manufacturers must provide transaction
Rationale for federal drug regulation
-Protection of the public against adulterated and misbranded products
-Necessity of balancing "direct" and "indirect" regulation
FDA
-Housed under DHHS
-Authority for administering the FDCA
-Secretary appointed by president with confirmation of senate
Structure of FDA
-National HQ and extensive force field
-Four offices under commissioner
--Office of Foods and Vet Med
--Office of Global Regulatory Operations and Policy
--Office of Medical Products and Tobacco
--Office of Operations
Office of Medical Products and Tobacco
-Center for Drug Evaluation and Research (CDER)
-Center for Biologics Evaluation and Research
-Center for Devices and Radiological health
-Center for Tobacco products
Functions of FDA
-Rulemaking
-Issue guidance documents (not force of law)
-Incorporate advice from standing advisory committee of outside experts
Drug
-Articles recognized in the USP or homeopathic PC
-Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease (part B)
-Articles other than food intended to affect the structure or function of the body (part C)
-Intentio
Evidence product is a drug
Labeling
Advertising
Nature of the product
Food or drug?
-Depends on intended use
-Congress likely intended the meaning of food in the exclusion from part C of drug definition to apply to food used for its ordinary purpose and in an ordinary manner
Legal food categories
-Specialty dietary foods
-Medical foods
Publicly-conceived food categories
-Nutraceuticals and functional foods
Health or disease claims for foods
-Could result in product being considered a drug
-Nutrition labeling and education act of 1990 and FDAMA allow foods to contain health claims if approved by the FDA by regulation or by the significant scientific agreement test
-Manufacturer must submit co
Dietary supplement and/or drug
-Dietary supplement health education act
-Created DS (Category of food)
-DS do not require premarket approval
Dietary supplement
-Vitamin, mineral, or other botanical
-Amino acid
-Or substance used to supplement the diet by increasing total dietary intake
Four types of nutritional support claims
-DSHEA
-Benefiting a classical nutritional deficiency dis
-Describing role of the DS in affecting the structure/function of the body
-Characterizing the mechanism by which a DS acts to maintain the structure or function
-Statements of general well-being
*
Health or disease claims
-Permitted either if the FDA approves the claim by regulation or by significant scientific agreement test
-Pearson v. Shalala
-FDA allows qualified and unqualified claims but need disclaimer and must not be false or misleading
Dietary supplements containing drugs
- DSHEA excludes an article as a DS if it was approved as a drug prior to being marketed as DS
-Pharmanex case establishes that DSs cannot be specially manufactured to concentrate the natural drug ingredient
FDA removal of DS
-Only if the product is adulterated
-Ex: Ephedrine alkaloid DS
-DS and nonprescription drug consumer protection act requires manufacturers to report serious adverse events
Device
-Excludes articles that achieve their purpose through chemical action and metabolism
Cosmetic
Generally includes topical articles intended for cleansing, beautifying, or altering appearance
-Can become a drug if the seller makes a health or structure/function claim
Labeling
-Includes labels
-Written or printed or graphic matter accompanying (doesn't have to be in the same package) the article
-If it is not labeling, it is advertising
USP official compendia
-Published by the USPC
-Sets uniform standards
-USPC works closely with the FDA, but is private
HPUS
-Publishes standards for homeopathy products by HPCUS, a private organization
-Role and legal authority of this
Prohibited acts
-Violation of FDCA to strict liability, good faith excuse applicable
-Receipt and delivery of adulterated or misbranded drug
-Doing any act which causes a drug to be counterfeit
-Alteration, mutilation, etc, of the labeling
FDA enforcement authority
Injunction
Criminal action
Seizure of products
Warning letters
Park doctrine
Corporate officer liability
-Affirmative duty of corporate officers to be aware of and correct violations
Product recalls
-FDAAA established FDA authority to order this for certain products but not drugs
-Manufacturers responsible for notifying seller and seller for notifying consumers if necessary
-Pharmacists responsible for knowing p
Adulteration
-Both facility and product
-Drug if strength, quality, or purity differs from compendia standards, unless plainly stated on the label (or w/o compendia)
-No CGMP
-Failure to manufacture tamper-resistant container when required by law (also misbranding)
Misbranding
-Labeling must not be false or misleading, including HC economic info
-Must include list of active ingredients and quantity
-Inactive ingredients
-Adequate directions for use and adequate warnings against use
--If not adequate directions, must be adequate
Black Box warnings
-Required in labeling when use of a drug may lead to death or serious injury
-About 450 Rx drugs
NDC
-First segment - distributor or manufacturer
-Second - strength, dosage form, formulation
-Third - Package size and drug type
-Billing - 11#