Federal Laws/Acts/Amendments Flashcards
When was the Pure Food and Drug Act established?
1906
What did the Pure Food and Drug Act do? (2 major things)
-Prohibited food and drugs that were distributed through interstate commerce to be adulterated or misbranded
-Required a label to be placed on products
What did the Pure Food and Drug Act NOT do? (4 things)
Require manufacturers to list ingredients
Require manufacturers to label directions for use
Regulate cosmetic products
Regulate medical devices
When was the Food, Drug, and Cosmetic Act created?
1938
Why was the Food, Drug, and Cosmetic Act created?
In 1937, there were 107 deaths from antifreeze
Significance of the Food, Drug, and Cosmetic Act of 1938
It required any new drug wanting to be placed on the market to be tested for safety when used according to directions on the label
Requirements created from the Food, Drug, and Cosmetic Act
Adequate directions for use and required warnings about habit-forming drugs contained in the product
The Food, Drug, and Cosmetic Act was the first law that applied to what?
Cosmetic products and medical devices
What happened with drugs that were approved before the Food, Drug, and Cosmetic Act?
They were grandfathered into the system (Synthroid, digoxin, NTG, phenobarbital)
The Food, Drug, and Cosmetic Act also established what major government organization?
The FDA!
When was the Durham-Humphrey Amendment passed?
1951
What was the Durham-Humphrey Amendment added onto?
The Food, Drug, and Cosmetic Act (FDCA)
What did the Durham-Humphrey Amendment establish?
Legend and OTC drugs
What are legend drugs?
Drug that require medical supervision (so basically prescription drugs)
Legend drugs do not have to list what?
“Adequate directions for use”
Legend drugs require what on the label?
“Caution: federal law prohibits dispensing without a prescription”
What are OTC drugs
Drugs that don’t require medical supervision for use
What do OTC drugs require on the label?
“Adequate directions for use”
What did the Durham-Humphrey Amendment also provide?
Verbals and prescription refills
When was the Kefauver-Harris Amendment established?
1962
What was the Kefauver-Harris Amendment added onto?
The FDCA
Why was the Kefauver-Harris Amendment established?
Public concerns over the birth defects of thalidomide
What did the Kefauver-Harris Amendment put into law?
All new drugs marketed in the US had to be shown to be SAFE AND EFFECTIVE
What happened to the drugs that were approved before the Kefauver-Harris Amendment was passed?
All the drugs approved between 1938-1962 had to undergo re-testing
According to the K-H Amendment, who has the authority over prescription drug advertising?
The FDA
What do research subjects in clinical investigations have to do according to the K-H A?
Give informed consent
According to the K-H A, what is now required to report?
ADRs
What did the K-H A create?
Good Manufacturing Practices (GMP) requirements
What do GMPs do?
Define conditions for drug manufacture in the US
Exception to GMPs
Not required for compounding products or supplements
When was the Medical Device Amendment created?
1976
What is the Medical Device Amendment an amendment to?
The FDCA
What does the Medical Device Amendment do?
Provides for better classification of medical devices
According to the Medical Device Amendment, how do you classify a medical device?
According to specific function
Establishment of performance standards
Meets pre-market approval requirements
Conformance with GMP standards
Requirements for adherence to record and reporting requirements
When was the Orphan Drug Act created?
1983
What is an orphan drug?
A drug used to treat diseases that affect less than 200K people that has limited potential for profitability
What did the Orphan Drug Act provide?
Various tax and licensing incentives to manufacturers to make the development of orphan drugs more appealing
When was the Drug Price Competition and Patent-Term Restoration Act created?
1984
Other name for the Drug Price Competition and Patent-Term Restoration Act
Waxman-Hatch Amendment
What was the Waxman-Hatch Amendment an addition to?
The FDCA
Why was the Waxman-Hatch Amendment created?
It attempted to resolve a dispute between generic drug and brand name manufacturers
What did the Waxman-Hatch Amendment do?
Streamlined drug approval process for generic drugs- they needed to show bioequivalence
What did the Waxman-Hatch Amendment provide?
Innovative drug manufacturers with incentives to develop new drug products
When was the Prescription Drug Marketing Act created?
1987
What did the Prescription Drug Marketing Act do?
Control distribution of prescription drug samples
What did the Prescription Drug Marketing Act prevent?
They prevented hospitals and other healthcare entities from reselling pharmaceuticals to other businesses to prevent fraud/abuse
When was the FDA Modernization Act created?
1997
FDA Modernization Act: fast-track review
It allowed a fast-track review of New Drug Applications (NDAs) to expedite approval of new drugs for serious or life-threatening conditions (like AIDS)
FDA Modernization Act: clarifications about compounding
Individual states need to regulate compounding
Pharmacies are exempt from the strict regulatory federal GMP standards and requirements for submission of NDAs
FDA Modernization Act: change of prescription drug legend
Changed “Caution: federal law prohibits dispensing without a prescription” to “Rx only”
FDA Modernization Act: provision that required certain substances to be labeled
“Warning- may be habit forming” was eliminated
FDA Modernization Act: manufacturers and research
Encouraged manufacturers to conduct research for new uses of current drugs and submit supplemental NDAs for new uses
What can manufacturers do about unapproved uses of an FDA-approved drug?
They can publicly disseminate limited information on such unapproved uses if a statement is included specifying that the use isn’t FDA-approved
When was the Combat Methamphetamine Epidemic Act created?
2005
Purpose of CMEA
Enacted to curb the illicit production of methamphetamine, so it regulates the sale of OTC meds containing PSE
Daily sales limit on PSE
3.6 grams/day
Monthly purchase limit on PSE
9g in a 30-day period
Monthly purchase limit on PSE for mail-order/mobile retail
7.5g in a 30-day period
When was the Affordable Care Act signed?
2010 (Obama Care)
What did the ACA require of all individuals?
To have healthcare!
How did the ACA allow people to get healthcare?
Health insurance exchanges were created, which allowed individuals and families to purchase health insurance with subsidies available based on their federal poverty level
Small businesses received tax credits if they provided healthcare coverage to employees
What did the ACA do for transactions?
They required timely and transparent claims using standard electronic transactions
What did the ACA stop?
Agreements between brand name and generic drug manufacturers that limit or delay competition from generic drugs
What did the ACA start to phase out?
The donut hole (coverage gap) when patients have to cover the entire cost of their prescription meds themselves
I think as of 2024 that the donut hole closed
When was the Inflation Reduction Act signed?
2022
What did the Inflation Reduction Act require of the federal government?
Required the federal government to negotiate prices for some drugs covered under Medicare Part B and D with the highest total spending starting in 2026
What did the Inflation Reduction Act require of drug companies?
Drug companies have to pay rebates to Medicare if prices rise faster than inflation for drugs used by Medicare beneficiaries starting in 2023
What did the Inflation Reduction Act cap?
It capped OOP spending for Medicare Part D enrollees and made other Part D benefit design changes starting in 2024
What did the Inflation Reduction Act do for the price of insulin?
Limited the monthly cost sharing for insulin to $35 for people with Medicare starting in 2023
What did the Inflation Reduction Act do for vaccine costs?
Eliminated cost-sharing for adult vaccines covered under Part D and improved access to adult vaccines in Medicaid and CHIP starting in 2023
What did the Inflation Reduction Act do for benefit eligibilities?
It expanded the eligibility for full benefits under the Part D Low-Income Subsidy Program starting in 2024
What did the Inflation Reduction Act delay?
The Trump administration’s drug rebate rule starting in 2027
When was the Drug Quality and Security Act signed?
2013
What do the electronic tracing systems from the DQSA do?
They protect US consumers by readily identifying compromised prescription pharmaceutical products, including those that may be counterfeit, stolen, contaminated, dangerous, or harmful. Then it will be removed from the supply chain
What requirements did the DQSA create?
It created requirements for trading partners regarding the tracing of prescription pharmaceutical products during distribution across the US
Primary goal of HITECH
Promote the adoption and meaningful use of health information technology across the US healthcare system
How did HITECH get people to adopt EHRs?
It provided HCPs, hospitals, and clinics incentives via Medicare and Medicaid to adopt EHRs
How did HITECH allow people to get incentives?
They had “meaningful use” criteria people had to meet
What happens to providers who don’t adopt EHRs?
They get penalized by getting reduced Medicare reimbursements
HIPAA/HITECH Violation Tier 1
Person didn’t know that the person violated the provision (and the person wouldn’t have known)
HIPAA/HITECH Violation Tier 2
Violation was due to reasonable cause and not willful neglect
HIPAA/HITECH violation Tier 3
Violation was due to willful neglect that’s timely corrected
HIPAA/HITECH violation Tier 4
Violation was due to willful neglect that isn’t timely corrected
What did HITECH facilitate the creation of?
Health information exchanges (HIEs) that allow the secure exchange of health information between different healthcare organizations
What is an adulterated drug according to NYS?
If a drug’s strength, purity, or quality differs from what it claims or if substances are mixed to reduce its quality
So basically: if the drug’s strength, purity, or quality falls below the standards in an official compendium
What is a misbranded drug according to NYS?
Its labeling is false or misleading, lacks required information such as manufacturer details or content quantity, or fails to present necessary information conspicuously to be read under normal conditions
So basically: if the packaging is misleading, it imitates another drug, or is sold under another drug’s name
Misbranded drugs: drugs that contain habit-forming substances have to have what?
A warning label
Misbranded drugs: what should compounded drugs/drugs not recognized in an official compendium have?
Bear the common or usual name and active ingredients
Misbranded drugs: what should labeling include?
Adequate usage directions and warnings, ensure that it meets compendium standards, and avoid imitating or misleading consumers about the drug’s identity or origin
FDA Class I Recall definition
There is a reasonable probability that the use of, or exposure to a violative product, will cause serious adverse health consequences or death
FDA Class II Recall definition
Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FDA Class III Recall definition
Use of, or exposure to, a violative product is not likely to cause adverse health consequences
Market withdrawal definition
Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation.
Medical safety device alert definition
Issued in situations where a medical device may present an unreasonable risk of substantial harm. In some cases, it can be a recall
