Lec 3 FDCA (Week 2)

Describe the purpose of the Food, Drug and Cosmetics Act (FDCA)

To protect consumers from adulterated or misbranded foods, drugs, cosmetics and devices

Contrast the 1906 Pure Food and Drug Act with the 1938 FDCA

The Pure Food and Drug Act prohibited misbranding and adulteration. The FDCA did the same with expanded definitions, inclusion of cosmetics and devices, and additionally required proof of safety, adequate directions for use, and warnings about habit-forming properties.

Durham Humphrey Prescription Drug Amendment 1951

• Created two classes of drugs- prescription and OTC

• Authorized oral prescriptions and refills of prescription drugs

Kefauver-Harries (Drug Efficacy amendment 1962)

Required drugs to be proved effective, retroactive to drugs marketed in 1938 or later

Poison Prevention Packaging Act (1970)

Intended to protect children from accidental poisonings by requiring specific container closures

Orphan Drug Act (1983)

Provides tax and licensing incentives for manufacturers to develop drugs for rare diseases or conditions

Drug Price Competition and Patent Term Restoration Act (1984)

Waxman-Hatch Amendment

Increases availability of generic drugs by streamlining the generic drug approval process and giving patent extensions to innovator drugs

Prescription Drug Marketing Act (PDMA 1987)

Sales restriction and record-keeping requirements for drug samples

Dietary Supplement Health and Education Act

Dietary supplements are more food than drugs

Manufacturers can make claims that would have been illegal under the FDCA

FDA Modernization Act

Created fast track approval process for drugs for serious life threatening illness

Dietary Supplement and Non-Rx Drug Consumer Protection Act

Two parallel and mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements

Food and Drug Administration Amendments Act (FDAAA 2007)

Gave FDA authority to mandate labeling changes related to safety and require companies to do REMS

Biologics Price Competition and Innovation Act (2010)

Created a regulatory framework to facilitate the approval of generic biologics (or biosimilars), including interchangeability

Drug Quality and Security Act (2013)

Clarifies FDA oversight for pharmacies engaged in large scale compounding

Drug supply chain security act adds “track and trace” requirements

Drug

(A) articles recognized in the official United States Pharmacopoeia (USP), official Homoeopathic Pharmacopoeia of the United States (HPUS), or official National Formulary (NF), or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

Biological Product

Products derived from living organisms applicable to the prevention, treatment or cure of a disease or condition of human beings

Food

Articles used for food or drink for man or other animals, chewing gum

Device

Like a drug BUT does not achieve its intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes

Cosmetic

Articles 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

Dietary Supplement

Explain strict liability as it pertains to FDCA

The commission of any of the listed offenses violates the FDCA regardless of the person’s intentions or knowledge.

Adulteration

• Consists of any filthy, putrid or decomposed substance or

  1. Been prepared or held under unsanitary conditions

  2. Not manufactured in conformity with good manufacturing practice

  3. Container is composed of any poisonous substance

  4. Color additive which is unsafe

• Strength, quality or purity differing from official compendium

  1. OK when its difference in strength, quality or purity is plainly stated on its label

• Misrepresentation of strength where drug is unrecognized in compendium

• Mixture with or substitution of another substance 

• Delayed, denied or limited inspection; refusal to permit entry or inspection

Misbranding

1. False or misleading information

2. Failure to meet packaging and labeling requirements

3. Other conditions

   1. Prepared at an unregistered facility

   2. Prepared at facility with unpaid fees

   3. Failure to follow REMS requirements

List the enforcement actions FDA can take in response to a violation of the FDCA

• Warning letter

• Injunctive action: force manufacturer to not market product

• Criminal proceedings

• Seizure of misbranded or unadulterated products 

• Voluntary Product recall

Differentiate the 3 classes of recalls and explain the pharmacist’s role when drug products are recalled

1. Class I - reasonable probability that the product will cause serious adverse health consequences or death

2. Class II- may cause temporary or medically reversible adverse health consequences 

3. Class III- not likely to cause adverse health consequences