2.1 - Historical Overview of the Federal Food, Drug, and Cosmetic Act

Earmarks of a profession

- Specialized Intellectual Technique

- Independent Judgement and Individual Responsibility

- organized literature

- self organization

- social regulation

social regulation

- ethical codes

- voluntary associations vs. state regulations

- Make sure people aren’t fooled or taken advantage of by fake “experts.

Sayadilah

(973-1051) pharmacists were examined and licensed by Muhtasib

Edict of Frederick II

- separation of pharmacy from medicine

- official supervision of pharmaceutical practice

- oath to prepare drugs reliably and make sure their quality

Henry VI (1447)

allowed shopkeepers to inspect medicinal herbs and ingredients to make sure they were safe and NOT harmful to people’s health before selling them

Society of Apothecaries (1617)

authorities were given the power to check pharmacies and dispose of any unsafe medicines publicly

Don Alexandre O’Reily

issued an edict in 1770 that help separate medicine, pharmacy, and surgery

Jean Peyroux

first pharmacist known to have been examined and licensed in the US

Drug Importation Act of 1848

- imported drugs were unreliable or tampered with, and people were starting to notice and raise concerns

- NY COP and NY Academy of Medicine lead legislation

Model Law 1900

- written by James H. Beal

- adopted by APhA

- defined the difference between pharmacist and merchant

- established professional pharmacy

Harvey Wiley

- aided in enacting national food and drug statute

- helped Congress enact legislation

- used journalist “muckrackers” to expose shocking conditions in food processing and its ingredients

Federal Pure Food and Drug Act

- prohibited adulteration and misbranding of drugs between states

- penalties if found guilty

- amended in 1912 to prohibit false and fraudulent efficacy claims (lead to USP and NF)

Elixir Sulfanilamide disaster

- caused over 100 deaths

- contained diethylene glycol (antifreeze)

- company did NOT test for safety

- misleadingly labeled → “elixir” (typically contains alcohol, this did NOT)

Food, Drug, and Cosmetic Act (FDCA) of 1938

- basis for all subsequent amendments

- required that NO new drug/cosmetic could be marketed until it was proven safe for use under the conditions described by the FDA

- Required that labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs

FDCA 1941 Amendment

- required batch certification of safety and efficacy of penicillin and insulin to measure uniform potency

- eliminated in 1997

A drug is considered adulterated if . . .

- its strength, quality, or purity differ from the label.

- its strength, quality, or purity differ from compendia standards (USP-NF), unless clearly stated on the label

Durham Humphrey Amendment (1951)

- required all drugs to be labeled with “adequate directions of use”

- established OTC vs prescription drugs

- subjected prescription drugs to new drug application (NDA)

Food Additives Amendment (1958)

- required components added to food products receive premarket approval for safety

- Unless ‘Generally recognized as safe’ (GRAS)-adequately shown to be safe under conditions of intended use

Delaney Clause

prohibited approval of any food additive that was cancerous

Color Additive Amendments (1960)

- required manufacturers to establish the safety of color additives in food, drugs, and cosmetics

- FDA can approve a color for one specific use

Kefauver-Harris Amendment (1962)

- required drugs to be both safe and effective

- established Good Manufacturing Practices (GMP)

- more extensive controls for clinical trials = informed consent, reporting of ADRs

- passed as a result of thalidomide incident (caused birth defects)

Good Manufacturing Practices (GMP)

a set of regulations that establish the minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product

Medical Device Amendments (1976)

- classification of devices according to f(x)

- premarket approval of safety and efficacy

- establish performance standards

- conform to GMP regulation and record/reporting requirements

Orphan Drug Act of 1983

provided tax advantages and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of rare diseases or conditions

Drug Price Competition and Patent Term Restoration Act of 1984

- streamlined approval pathway for generic drug products

- Patent extensions for innovator drugs to provide incentives for manufacturers to develop new drugs

Prescription Drug Marketing Act of 1987

- establishes sale restrictions and recordkeeping requirements for prescription drug samples

- requires state licensing of drug wholesalers and prevents healthcare entities from reselling pharmaceutical products

- resulted from intense lobbying and

negotiating between the generic drug manufacturers and the manufactures of innovator drugs

Safe Medical Devices Act of 1990

- gave FDA additional authority to post-marketing Surveillance for monitoring products after the hit the market

- helps expediate premarket approval process

- device tracking for maintaining traceability of certain devices

- helped strengthen Medical Device Act (MDA) of 1976

Generic Drug Enforcement Act of 1992

- authorized FDA to ban individuals or firms from participating in drug approval process if convicted of related felonies

- imposed severe civil penalties for false statements, bribes, failures to disclose materials, etc.

Prescription Drug User Fee Act (1992)

- requires manufacturers seeking NDAs to pay fees for applications and supplements, to review clinical studies

- required private industry to shoulder part of the costs for the FDA to review clinical studies for new drugs to speed up the NDA reviews

- MUST be reauthorized every 5 years

Nutrition Labeling and Education Act of 1990

Mandates 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 (DSHEA)

- defining dietary supplements and permitting manufacturers to make certain claims that otherwise would have been illegal under the FDCA.

- forced the FDA to regulate dietary supplements more as foods than as drugs

Food and Drug Administration Modernization Act (1997)

- Creates a fast-track approval process for drugs intended for serious or life-threatening disease

• Establishes a data bank on clinical trials, authorizes scientific panels to review clinical investigations, and expands the rights of manufacturers to disseminate unlabeled use information.

Medical Device Modernization Act of 2002

- similar to Prescription Drug User Fee Act

- established user fee requirements for premarket reviews of medical devices and performance goals for premarket reviews

- Inspections can be conducted at establishments by accredited third parties

FDA Amendments Act of 2007

Require companies to implement "risk evaluation and mitigation strategies" (REMS) to ensure that the benefits of a drug or biological product outweigh the risks.

Patient Protection and Affordable Care Act of 2010

- Provided sweeping changes throughout the entire healthcare system

- Added healthcare law beyond the scope of the FDCA

- Directly and indirectly affected other laws related to pharmacy practice

FDA Safety and Innovation Act of 2012

- adds new user fees for generic drugs and

biosimilars

- reduces drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages, and enhancing the exchange of prescription drug diversion information across state lines.

- Allows the FDA to inspect foreign drug manufacturers, target problematic sites

Drug Quality and Security Act of 2013

- Clarified and strengthened FDA oversight over pharmacies engaged in large-scale compounding & shipping of sterile products to other licensed entities (outsourcing facilities)

- outsourcing facilities MUST comply with GMP and adds “track-and-trace requirements”

- Manufacturers must provide transaction information to purchasers and in turn must provide transaction information to subsequent purchasers

- passed in response to meningitis outbreak in New England

Cures Act (2016)

- streamlined and accelerated the drug development and approval process by creating new clinical trial design options

FDA Reauthorization Act of 2017 (FDARA)

- amends FDCA to revise and extend the user-fee programs

- Food and Drug Omnibus Reform Act = encourages clinical trial diversity