3. Federal Regulation of Development, Production, and Marketing

In what order were drugs established pure, safe, and effective?

1. pure

2. safe

3. effective

What did the Pure Food and Drug Act of 1906 do?

required purity of drugs

What did the Food, Drug, and Cosmetic Act of 1938 do?

Required that any new drug be proved safe for use under the conditions described on the label

Forms the basis of all modern U.S. drug regulation

FDCA

What did the Durham-Humphrey Amendment of 1951 do?

1. created prescription and legend (otc)

2. authorized PO prescriptions and refills

What did the Kefauver-Harris Amendment of 1962 do?

1. required proof of efficacy

2. applied efficacy requirement to drugs marketed 1938-1962

What did the Medical Device Amendments of 1976 do?

Required premarket approval for some medical devices

What did the Drug Price Competition and Patent Term Restoration Act of 1984?

sped up the generic drug approval process

Generics need to prove they’re equal to brand

What did the Prescription Drug User Fee Act of 1992 do?

sped up the new drug application approval process by charging 4.6 million

What did the Nutrition Labeling and Education Act of 1990 do?

1. authorized the use of some health claims on product labeling

What did the Dietary Supplement Health and Education Act of 1994 do?

1. exempted dietary supplement manufacturers from pre-market approval

What did the Food and Drug Administration Amendments Act of 2007 do?

1. post-market clinical studies to assess risks

2. REMS

What department is the FDA a part of?

Department of Health and Human Services

What branch of the federal government is the FDA a part of?

Executive Branch

Who is the FDA headed by?

commissioner

Who is the commissioner appointed by?

president of the united states

Who is the commissioner confirmed by?

senate

Who does the commissioner report to?

secretary of health and human services

Regulations issued by the FDA is _________ (legally/not legally) binding.

legally

Guidance documents issued by the FDA is _________ (legally/not legally) binding.

not legally

What are the definitions of food according to the Food, Drug, and Cosmetic Act?

1. articles used for food or drink for humans or animals

2. chewing gum

What are the definitions of drugs according to the Food, Drug, and Cosmetic Act?

1. diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals

2. affect the structure or any function of the body of humans or animals

The Food, Drug, and Cosmetic Act defined medical devices?

1. does not achieve any of its principle intended purposes through chemical action within or on the body

2. not dependent upon being metabolized for the achievement of any of its principle intended purposes

__________ is a vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

Biologics

__________ are articles that are intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.

Cosmetics

Is soap a cosmetic?

No

__________ is a product that is intended for ingestion, supplement the diet and contains a vitamin, mineral, herb, botanical or amino acid.

dietary supplement

Does food require pre-market approval?

No

Do prescription drugs require pre-market approval?

Yes

Do non-prescription drugs require pre-market approval?

Yes

Do cosmetics require pre-market approval?

No

Do medical devices require pre-market approval?

depends on class

Do dietary supplements require pre-market approval?

No

Do biologics require pre-market approval?

Yes

New Drug Definition

o New chemical entity

o New ingredient in an already-approved drug

o Changes in the proportion of ingredients in an already-approved combination product

o New intended use for an already-approved drug

o Change in the dosage, method, or duration of administration of an already-approved drug

What is the order of the 7 steps of the New Drug Approval Process?

1. pre clinical testing

2. investigational new drug application (IND) is filed

3. phase I clinical trials

4. phase II clinical trials

5. phase III clinical trials

6. new drug application (NDA) is filed

7. phase IV clinical trials

What are acts prohibited by the Food, Drug, and Cosmetic Act (FDCA)?

producing, delivering, receiving, dispensing, or offering for sale any food, drug, biologic, device or cosmetic that is adulterated or misbranded

What are the enforcement mechanisms available to the FDA?

1. warning letters

2. injunctive action (sue)

3. seizure (take it)

4. criminal proceedings (criminal court)

Product Recall

By FDA mandate (for medical devices, biologics, and food – NOT for drugs)

Class ____ recall is when there is reasonable probability that the product will cause serious adverse health consequences or death.

I

Class ____ recall is when the product may cause temporary or medically reversible adverse health consequences, but probability of serious adverse health consequences is remote.

II

Class ____ recall is when the product is not likely to cause adverse health consequences.

III

_________ is a voluntary adverse event reporting system administered by the FDA for serious adverse events, potential and actual product use errors, and product quality problems.

MedWatch Voluntary Reporting System

__________ is a mandatory for healthcare professionals and voluntary for consumers reporting system administered by the FDA and CDC for new or rare vaccine adverse events

Vaccine Adverse Events Reporting System (VAERS)

Who regulates advertising and promotion of prescription drugs, biologics, and prescription medical devices?

Food and Drug Administration (FDA)

Who regulates advertising and promotion of non-prescription drugs, non-prescription medical devices, and dietary supplements?

Federal Trade Commission (FTC)

What are the requirements for the advertising of prescription drugs, biologics, and prescription medical devices?

1. name of product

2. A summary of information relating to adverse effects, contraindications, and efficacy

3. fair balance between ADRs/contraindications and efficacy

What forms of advertisement are exempt form the requirements of adverse effects, contraindications, and efficacy?

1. reminder advertising

2. advertising used in compounding by pharmacists

3. institutional advertising

4. help-seeking or disease awareness communications

What 3 types of acceptable medical information that may be distributed by manufacturers for off-label uses?

1. published research (journal articles)

2. reference texts

3. clinical practice guidelines

All peer reviewed

What is the only requirement for advertising for non-prescription drugs, non-prescription medical devices, and dietary supplements?

non-deceptive

Note that the FTC doesn’t need not prove that consumers were actually misled, only that they are

likely to be misled by the advertisement.

What are the enforcement actions that may be taken by the FTC for deceptive advertising of non-prescription drugs, non-prescription medical devices and dietary supplements?

1. order the manufacturer to cease deceptive advertising

2. issue corrective action

3. require disclosure of adverse effects

What can’t the FTC do for deceptive advertising of non-prescription drugs, non-prescription medical devices and dietary supplements?

Seize or recall

Incorrect drug name on the label (whether placed by the manufacturer or the pharmacy)

Misbranding

Missing lot numbers or expiration dates

Misbranding

Repackaged medication without proper labeling

Misbranding

Dispensing Zofran orally disintegrating tablets in a Ziploc bag

Misbranding

Manufactured in an unregistered facility

Adulteration

Counting on a dirty tray in the pharmacy

Adulteration

Storing in an unclean automated dispensing machine

Adulteration

Temperature not adequately controlled

Adulteration

If a drug manufacturer refuses to recall a product upon FDA request, the FDA must

seize the drug or seek an injunction in civil court to remove the product from the market

is required only to present a brief summary of adverse effects, contraindications, and efficacy

Advertising

must include all of the information required to be in the package insert

Labeling