US History (Ch. 1) Flashcards
1
Q
What are the three branches of the US Government?
A
- The Legislative Branch
- The Executive Branch
- The Judicial Branch
2
Q
What branch of the US government is responsible for making laws?
A
Legislative
3
Q
What branch of the US government is responsible for executing laws?
A
Executive
4
Q
What branch of the US government is responsible for evaluating laws?
A
Judicial
5
Q
What does FDA stand for?
A
The US Food and Drug Administration
6
Q
How do the three branches of US government affect the FDA?
A
They guide the regulations for products that are under the FDA’s jurisdiction
7
Q
What are the two parts of Congress?
A
- The House of Representatives
2. The Senate
8
Q
How does Congress affect the FDA?
A
Congress uses its authority to 1) regulate interstate commerce, and 2) legislate federal statutes on food/drugs
9
Q
What is the process for a bill to become a statute?
A
Bill / Joint Resolution > Subject matter committees / public hearings > House/Senate votes > Signed by President > Statute
10
Q
What is a statute?
A
An enacted law
11
Q
What is a public law?
A
A law that affects society as a whole (e.g. food, drugs)
12
Q
What is a private law?
A
A law that affects an individual or a small group
13
Q
What is a slip law?
A
The first official publication of a statute (published separately)
14
Q
What is the NARA, and what do they do?
A
National Archives and Records Administration (NARA),(Office of the Federal Register), prepares slip laws and adds marginal notes with explanatory info
15
Q
What is the US Statutes at Large?
A
A permanent collection of all laws enacted during each session of Congress (prepared by the Office of the Federal Register)
16
Q
What is the United States Code (U.S.C.)?
A
Statutes are published, or “codified” in the U.S.C. (e.g. Title 21 is federal statutes on food and drugs), prepared by the Law Revision Council of the House of Representatives
17
Q
What is the HHS?
A
Department of Health and Human Services (HHS)
18
Q
What branch of the government is the FDA under?
A
Executive branch, HHS
19
Q
What is the purpose of the FDA?
A
To implement statutes through regulations, the mission is to protect public health by ensuring the safety of 1) food, 2) drugs, and 3) cosmetics
20
Q
What are regulations?
A
interpret laws and describe how they will be enforced
21
Q
What is rulemaking?
A
A process the FDA uses to propose and establish regulations
22
Q
What is the Administrative Procedure Act (APA) of 1946?
A
Administrative Procedure Act (APA) of 1946:
Requires agencies to keep the public informed, and gives the public the right to participate in the rulemaking process by commenting on proposed regulations
23
Q
What is the Government in the Sunshine Act of 1976?
A
Government in the Sunshine Act of 1976:
Requires advanced notice of rulemaking meetings, and that those meetings are open to the public (Unified Agenda provides regulatory agenda with planned rulemaking activities for 6 months)
24
Q
What is the Federal Register (FR)?
A
Where new regulations, or changes to existing regulations are published (similar to US Statutes at Large)
25
What is the Code of Federal Regulations (CFR)?
Where regulations are published (similar to U.S. Code), organized into 50 titles
26
What is the CFR formatting?
Title #, "CFR", Part #, ".", Section # (e.g. 21 CFR 10.3)
27
What are FDA guidance documents?
Used to convey the FDA's "current thinking" or enforcement priorities to establish regulatory principles and practices aligned with that thinking (not legally binding)
28
What is a treaty?
A written agreement between sovereign states (or other international bodies) dictating terms binding the parties to the agreement, becoming international law once signed
29
What is a trade agreement?
Establishes terms between parties regarding tariffs/trade restrictions
30
What is case law?
Law based on judicial opinions (as opposed to legislative law), judicial decisions set precedents that influence food and drug laws/regulations
31
What is the United States Reports?
The official record of the proceedings of the Supreme Court
32
How have judicial opinions influenced food/drug regulations?
Regulating false claims, chemicals in the food supply, labeling, ability to prosecute responsible individuals of a corporation, drug efficacy, scope of drug/devices
33
Who is Harvey Wiley?
(1902) Had concerns about the safety of food preservation chemicals (Poison Squad experiments)
34
What was Upton Sinclair's book?
"The Jungle", described the unsanitary conditions in the meat packing industry
35
What is the Pure Food and Drug Act of 1906?
Pure Food and Drug Act of 1906:
Prohibited misbranded and unadulterated foods, drinks, and drugs from entering interstate commerce (the predecessor of the FD&C Act)
36
What is the Sherley Amendment of 1912?
Sherley Amendment of 1912:
| Prohibited labeling medicines with false therapeutic claims (however, burden to prove intent placed on govt.)
37
What is the Food, Drug, and Cosmetic Act (FD&C Act) of 1938?
Food, Drug, and Cosmetic Act (FD&C Act) of 1938:
- Manufacturers are required to provide scientific proof that new drugs were safe for their intended use prior to being placed on the market
- Cosmetics and medical devices now regulated
- Prohibit adding poisonous substances to food
- FDA allowed to prosecute
(repealed the Pure Food and Drug Act and the Sherley Amendment)
38
What was Elixir Sulfanilamide?
A significant public health event:
An antibacterial drug was dissolved in diethylene glycol for oral administration, no safety testing performed, and caused over 100 deaths
39
What is the Public Health Service Act (PHS Act) of 1944?
Public Health Service Act (PHS Act) of 1944:
- Gave the FDA authority over biological products (vaccines, serums)
- Requires application process for licensing new biological products
40
What is the Durham-Humphrey Amendment of 1951?
Durham-Humphrey Amendment of 1951:
- Defined prescription drug vs. over-the-counter drug
- Habit-forming or potentially harmful drugs must be prescription only
- Prescription drugs must have an RX statement
41
What is the Food Additives Amendment of 1958?
Food Additives Amendment of 1958:
| - Identified substances added to food that are GRAS substances, and non-GRAS that require marketing approval
42
What are GRAS substances?
GRAS: Generally Recognized As Safe
43
What is the Kefauver-Harris Amendment, aka Drug Amendments of 1962?
Kefauver-Harris Amendment, aka Drug Amendments of 1962:
| - Addresses standards for both SAFETY and EFFICACY that must be met before a drug is marketed in the US
44
Who was Frances Kelsey?
A significant public health event:
In the 1960's, Frances Kelsey was an FDA employee who reviewed the application for thalidomide, a morning sickness medicine marketed in 46 other countries. Not approved on basis of drug SAFETY, actually caused severe birth defects worldwide
45
Who was Senator Estes Kefauver?
In the 1950's, Senator Estes Kefauver called for reform on drug price-gouging, false advertising, and called for proof of EFFICACY
46
What law introduced the concepts of SAFETY and EFFICACY?
The Kefauver-Harris Amendment, aka Drug Amendments of 1962
47
What are the 1976 Medical Device Amendments (to the FD&C Act)?
1976 Medical Device Amendments:
- Established three medical device classes with different levels of regulatory scrutiny
- Device listing
- Establishment registration
- Adherence to Good Manufacturing Practices
48
What law introduced the requirements for device listing and establishment registration?
1976 Medical Device Amendments
49
What law caused medical devices to be regulated?
Food, Drug, and Cosmetic Act (FD&C Act) of 1938
50
What is the Cooper Commission?
In 1970, the Cooper Commission published the Cooper Report, which found that many deaths/serious injuries were caused by medical devices. (Led to the 1976 Medical Device Amendments)
51
What is the Orphan Drug Act of 1983?
Orphan Drug Act of 1983:
- Provides incentives for manufacturers to develop "orphan drugs" (originally defined as a drug for a disease or condition which is rare)
52
What is the Safe Medical Devices Act (SMDA) of 1990?
Safe Medical Devices Act (SMDA) of 1990:
- Added reporting requirements for device user facilities
- Defined a medical device
- Added requirements for device tracking and post-market surveillance
- Provides civil penalties for violating the FD&C Act
- Created incentives for orphan or humanitarian use devices
- Add preproduction design controls to the Current Good Manufacturing Practice (CGMP) regulation
53
What does SMDA stand for?
Safe Medical Devices Act (SMDA) of 1990
54
What are the 1992 Medical Device Amendments?
1992 Medical Device Amendments:
- Clarified terms
- Established a single reporting standard for device user facilities, manufacturers, importers, and distributors
55
When were design controls introduced to the QSR?
In 1996, design controls were added to the Quality Systems Regulation (QSR)
56
What does QSR stand for?
Quality Systems Regulation (21 CFR 820)
57
What is the Drug Price Competition and Patent Term Restoration Act of 1984, aka Hatch-Waxman Act?
Drug Price Competition and Patent Term Restoration Act of 1984, aka Hatch-Waxman Act:
- Established a process for approving drugs based on comparison to an already approved product (due to lengthy reviews)
- Exclusive marketing status for a period of time based on the drug's approval process time
- Provided patent term extension (as an incentive for time lost during regulatory approval process)
58
What is the Biologics Price Competition and Innovation (BPCI) Act of 2010?
Biologics Price Competition and Innovation Act of 2010:
- Biosimilar products can be approved based on similarity
(amended the PHS Act)
59
What is a biosimilar product?
A biological product may be demonstrated to be "biosimilar" if data shows that the product is "highly similar" to an already-approved biological product (ref. Biologics Price Competition and Innovation Act of 2010)
60
What does BPCI stand for?
Biologics Price Competition and Innovation Act of 2010
61
What does PDUFA stand for?
Prescription Drug User Fee Act
62
What is the Prescription Drug User Fee Act (PDUFA I) of 1992?
Prescription Drug User Fee Act of 1992 (PDUFA I):
- Allowed the FDA to collect user fees for drugs/biological products
- Required annual fees for each marketing establishment and each drug marketed
63
What is the purpose of user fees?
Industry provides the funding (through user fees) in exchange for the FDA's agreement to meet drug review performance goals/timelines
64
What does MDUFMA stand for?
Medical Device User Fee and Modernization Act
65
What is the Medical Device User Fee and Modernization Act (MDUFMA) of 2002?
Medical Device User Fee and Modernization Act (MDUFMA) of 2002:
- Required medical device companies to pay fees to the FDA
66
What is the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012?
Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012:
- Collect user fees from the generic drug and biosimilar biologics industry
- Reauthorized existing user fees
- Created new programs for timely access to medicine: reporting drug shortages and drug supply chain controls (suppliers become part of the QMS)
- Created the GAIN program
67
What does FDASIA stand for?
Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012
68
What does GAIN stand for?
Generating Antibiotic Incentives Now (GAIN)
69
What is the GAIN program?
Generating Antibiotic Incentives Now (GAIN):
- Provides incentives for antibacterial and antifungal drugs that treat serious or life-threatening infections that are designated as QIDPs
(e. g. fast-track, priority review, 5-year exclusivity extension)
70
What are QIPDs?
Qualified Infectious Disease Products (QIDPs)
71
What is the Food & Drug Administration Modernization Act (FDAMA) of 1997?
Food & Drug Administration Modernization Act (FDAMA) of 1997:
- Provided additional authority for drug/biologic postmarket monitoring
- Expedited review for some medical devices
- Clarified SMDA's humanitarian device provisions
- Allowed the FDA to recognize other national and international standards
- Encouraged the least burdensome approach of establishing substantial equivalence
- Repealed SMDA's tracking requirements for high-risk devices, and instead established process where FDA can mandate device tracking
72
What does FDAMA stand for?
Food & Drug Administration Modernization Act (FDAMA) of 1997
73
What does FSMA stand for?
Food Safety Modernization Act (FSMA) of 2011
74
What is the Food Safety Modernization Act (FSMA) of 2011?
Food Safety Modernization Act (FSMA) of 2011:
- Was a big food safety reform
- Gave FDA new enforcement authority
- Focused on prevention and risk-based food safety standards
- Provided new tools to respond to food problems
- FDA can hold imported foods to same food safety standards
75
What does DQSA stand for?
Drug Quality and Security Act (DQSA) of 2013
76
What is the Drug Quality and Security Act (DQSA) of 2013?
Drug Quality and Security Act (DQSA) of 2013:
- Title I: pharmacy compounding
- Title II: supply chain security
77
Drug Quality and Security Act (DQSA) of 2013: Title I, The Compounding Quality Act
Drug Quality and Security Act (DQSA) of 2013: Title I, The Compounding Quality Act:
- Created a category for an outsourcing facility
78
Drug Quality and Security Act (DQSA) of 2013: Title II, Drug Supply Chain Security Act
Drug Quality and Security Act (DQSA) of 2013: Title II, Drug Supply Chain Security Act:
- Electronic tracking system for certain prescription drugs in the US
79
What is the Controlled Substances Act of 1970?
Controlled Substances Act of 1970:
- FDA could recommend controls is a product has abuse potential
- The DEA places the product in a schedule I - VI
80
What does DEA stand for?
Drug Enforcement Administration
81
What is the Improving Regulatory Transparency for New Medical Therapies Act of 2015?
Improving Regulatory Transparency for New Medical Therapies Act of 2015:
- Requires the DEA to schedule a drug within 90 days after FDA recommendation
(amended the Controlled Substances Act)
82
What is the 21st Century Cures Act (CC&A) of 2016?
21st Century Cures Act (CC&A) of 2016:
- Patient-focused drug development
- Advancing new drug therapies
- Modern trial design and evidence development
- Patient access to therapies and information
- Antimicrobial innovation and stewardship
- Medical device innovations
- Improving FDA scientific expertise and outreach
- Medical countermeasures innovation
- Vaccine access, certainty, and innovation
(amends the FD&C Act and PHS Act)
83
What is patient experience data?
Includes data collected by any persons, including patients, their family members and caregivers, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers; intended to provide information about patients' experiences with a disease or condition, including a therapy's impact and patient treatment preference
84
What law allows the use of patient experience data?
21st Century Cures Act (CC&A) of 2016 (to improve patient-focused drug and device development by allowing patient experience data)
85
What is the Right to Try Act of 2018?
Right to Try Act of 2018:
- Allows patients with life-threatening diseases or conditions, who have tried all approved treatment options and are unable to participate in a clinical trial, to access unapproved treatments
