Chapter 1 - History of Food, Drug and Cosmetic Laws

Question 1

What does CFR stand for?

Answer 1

Code of Federal Regulations

Question 2

What are the three branches of the gov’t?

Answer 2

Executive, legislative, judicial

Question 3

What gov’t branch regulates interstate commerce and legislates federal statues on food and drugs?

Answer 3

Legislative Branch

Question 4

What is a statute?

Answer 4

An enacted law

Question 5

What gov’t branch has the power to execute the laws?

Answer 5

Executive Branch

Question 6

Which Branch does the FDA fall under?

Answer 6

Executive Branch

Question 7

What act requires agencies to keep the public informed and gives the public the right to participate in the rulemaking process by commenting on proposed regulations?

Answer 7

Administrative Procedure Act (APA) of 1946

Question 8

What CFR are regulations for food and drugs found in?

Answer 8

CFR Title 21

Question 9

What gov’t branch decides the constitutionality of federal laws and reviews and enforces orders of many federal administrative bodies?

Answer 9

Judicial Branch

Question 10

Pure Food and Drug Act of 1906

Answer 10

1. Prohibited misbranded and adulterated foods, drinks and drugs from entering interstate
2. In the early 1900s, concerns grew about the safety of chemicals added to food for preservation.
3. Poison Squad
4. Chicago meat-packing plant had strike by union about poor working conditions and unsanitary conditions
5. President Theodore Roosevelt appointed committee to investigate meat-packing conditions.
6. Pure Food and Drug Act was enforced by the Bureau of Chemistry in the Department of Agriculture, which became the FDA in 1930.

Question 11

Sherly Amendment

Answer 11

1. Prohibited labeling medicines with false therapeutic claims intended to defraud the purchaser.
2. Amended the Pure Food and Drug Act.

Question 12

FD&C Act

Answer 12

1. Prompted by Elixir Sulfanilamide drug leading to adult and children deaths. FDA had little authority to take action.
2. Significant changes include:
   - Manufacturers required to provide scientific proof new drugs were safe prior to market
   - Cosmetics and medical devices were regulated for the first time
   - Added poisonous substances to foods was prohibited except where unavoidable or required in production
   - FDA was given authority to bring federal court injunctions in addition to product seizures and criminal prosecutions for violations of the FDA&C Action
3. Repealed the Pure Food and Drug Act of 1906
4. Sherly Amendment was also removed

Question 13

Public Health Service Act of 1944

Answer 13

1. Gave FDA authority over biological products such as vaccines and serums.
2. Did not amend the FD&C Act

Question 14

Durham-Humphrey Amendment

Answer 14

1. Clarified what constituted a prescription drug versus an OTC drug.
2. Signed into law in 1951.

Question 15

Food Additives Amendment

Answer 15

1. 1958
2. Enacted to delineate substances added to food products generally recognized as safe (GRAS) and substances that may affect food characteristics that were not GRAS and required market approval.

Question 16

Kefauver-Harris Amendment

Answer 16

1. Patented drug containing thalidomide that treated nausea and morning sickness in pregnant women.
2. Babies born with physical defects or malformations.
3. Motivated profound changes in drug approval requirements. Address standards for both safety and efficacy that must be met before a drug may be marketed in the US.
4. Also known as the Drug Amendments of 1962.

Question 17

Medical Device Amendments

Answer 17

1. Technology boom introduced increasing complex medical devices.
2. 1976
3. Established three medical devices classes, each requiring different level of regulatory scrutiny, up to premarket approval.

Question 18

Orphan Drug Act of 1983

Answer 18

1. Guarantees an orphan product developer 7 years of market exclusivity following FDA’s approval.
2. Incentives also include tax credits for clinical research undertaken by a sponsor to generate data required for marketing approval.

Question 19

Orphan drug

Answer 19

A drug for a disease or condition which is rare (affects less than 200,000 persons).
Regulations for orphan drugs found in 21 CFR 316.

Question 20

Safe Medical Devices Act (SMDA) of 1990

Answer 20

1. Device user facilities must report device-related deaths to FDA and manufacturer
2. Device user facilities must report serious injuries to the manufacturer or FDA (if manufacturer is unknown)
3. Instituted device tracking and postmarket surveillance requirements
4. Gave authority to FDA to add preproduction design controls to the Current Good Manufacturing Practice (CGMP) regulation.
5. Amended the FD&C Act to create an incentive for developing orphan or humanitarian use devices.

Question 21

Medical Device Amendments of 1992

Answer 21

Clarify certain terms and establish a single reporting standard for device user facilities, manufacturers, importers and distributors.

Question 22

Drug Price Competition and Patent Term Restoration Act of 1984

Answer 22

1. Also known as Hatch-Waxman Act
2. This law established a process for approving drugs based on comparison to an already approved product and provided exclusive marketing status for a period based on the length of the new drug’s approval process or the branded drug patent status for generics.
3. Add provisions for patent term extension.
4. Object was to restore some of the incentive for innovation to US domestic drug companies, as federal premarket approval requirements became more expensive and time-consuming.

Question 23

Prescription Drug User Fee Act (PDUFA)

Answer 23

1. 1992
2. Authorized FDA to collect user fees from companies submitting applications for certain human drug and biological products.
3. Previously, taxpayers paid for product reviews through congressional budgets.
4. In this program, industry provides the funding in exchange for FDA’s agreement to meet drug review performance goals, which emphasize timeliness.
5. In 2002, expanded to other product categories that FDA regulates (Medical Device User Fee and Modernization Act)
6. User fees are subject to reauthorization by Congress every 5 years.

Question 24

FDAMA

Answer 24

1. Provides additional authority for drug and biologic postmarketing studies’ monitoring.
2. Repealed SMDA’s humanitarian device provisions and allowed FDA to recognize other national or international standards.
3. Emphasized using the least-burdensome means of establishing substantial equivalence.
4. Repealed SMDA mandatory tracking requirements for some high-risk devices and, instead, established requirements and a process under which FDA may order device tracking.
5. Allows clinical study sponsors to modify any investigational device or study protocol by submitting a notice of change.

Question 25

Supply Chain Globalization and Amendments to the FD&C Act in the 21st Century

Answer 25

1. FDA is tasked with monitoring manufacturer’s compliance with programs to ensure the safety of products they place on the market.
2. Recalls
3. Tracking and tracing drug product from its release point to its destination is important to protect against diversion, prevent counterfeit drugs from gaining market access and ensure product quality during transport.

Question 26

Food Safety Modernization Act (FSMA) of 2011

Answer 26

1. Most sweeping food safety reform in 70 years.
2. Prompted by food-borne illness from contaminated food products significantly impacting healthcare costs.
3. Gave FDA new enforcement authority designed to achieve higher compliance rates with prevention- and risk-based food safety standards and new tools to respond to and contain problems.
4. Gave FDA tools to hold imported foods to the same standards as domestic foods.

Question 27

FDASIA

Answer 27

1. 2012
2. Existing user fees were reauthorized, and FDA was given authority to collect user fees to fund reviews of generics and biosimilar products.
3. Created new programs to gain timely access to medicines, reporting requirements to avoid drug shortages and a new drug supply chain control requirement
4. Created GAIN (Generating Antibiotic Incentives Now), which provides incentives, such as fast-track, priority review and a five-year exclusivity extension for certain applications for the development of antibacterial and antifungal drugs that treat serious or life-threatening infections designated as qualified infectious disease product (QIDPs).

Question 28

Drug Quality and Security Act

Answer 28

1. 2013
2. Removed a provision under Section 503A concerning commercial speech regulation as it violated the First Amendment.
3. Title 1 addressed pharmacy compounding
   - Legislative response to a fungal meningitis outbreak due to contamination.
   - Significant concern over sterile drug processing under unsanitary conditions.
   - Created a new entity category called an outsourcing facility.
4. Title 2 addressed supply chain security.
   - Mandated implementing an electronic track and track system to identify and trace certain prescription drugs throughout the US supply chain.

Question 29

DEA

Answer 29

Drug Enforcement Administration

Question 30

Controlled Substances Act of 1970

Answer 30

1. DEA places a controlled substance in Schedule I, II, III, IV or V, depending on its potential for abuse, accepted medical use and psychological or physiological dependence severity.
2. FDA provides recommendation on schedule for drugs.

Question 31

Improving Regulatory Transparency for New Medical Therapies Act of 2015

Answer 31

1. Amended Controlled Substances Act of 1970.
2. Requires DEA to schedule a drug by issuing an interim final rule within 90 days of receiving a recommendation from the FDA.

Question 32

21st Century Cures Act (CCA)

Answer 32

1. 2016
2. Sweeping legislation to advance drug and device development.
3. Aims to improve patient-focused drug and device development by allowing the use of “patient experience data.”
4. Directs FDA to issue one or more guidance documents on collecting and using patient experience data and to issue reports assessing such data’s use in application approvals.
5. Directs FDA to establish a process for “qualification of drug development tools” to advance new drug therapies. I.e., biomarker, clinical outcome assessment, etc.
6. Incorporate modern trial design and evidence development for new drugs and biological products.
7. Directs FDA to evaluate the use of real-world evidence for
   
   • approving a new indication of an already approved drug
   • satisfying postapproval study requirements
8. Aim to improve patient access to therapies and information.
9. Gives FDA authority to approve an anti-microbial drug for a limited population if the drug is intended to treat a serious or life-threatening infection.
10. To promote medical device innovations, CCA authorizes use of flexible approaches to expedite development and provide for priority review of breakthrough device technologies.
11. Other changes include a pathway for standards recognition, ensuring adequate expertise in panels for device classification, allowing Institutional Review Board flexibility by not requiring a local board, least-burdensome device review, and cleaning and validation requirements for reusable devices
12. Identifies specific software categories that should not be regulated as devices.

Question 33

Right to Try Act

Answer 33

1. 2018
2. This law offers another way for patients diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options and are unable to participate in a clinical trial, to access certain unapproved treatments.