FDA law Flashcards
What is the Pure Food and Drug Act of 1906
Defines “Adulteration” and “Misbranding”
What is the Food, Drug and Cosmetic Act of 1938?
- Approval of drugs based on safety only
- Label: adequate directions for the use of a drug
What is the Durham-Humphrey Rx drug amendment of 1951?
Distinguish prescription from OTC
- Misbranding and Packaging
- Labels and Labeling requirements
What is the Kefauver-Harris act?
- Strengthened NDA process by requiring EFFICACY in addition to safety of approved drugs
- Good mManufacturing Practices (GMP): Licensing facility, right to inspect
- Required INFORMED CONSENT in clinical trials
- Enhanced requirement of reporting ADRs
What is the Drug Efficacy Study Implementation aka DESI?
It required the FDA to prove medications were safe and effective for its intended use
What is the Orphan Drug Act of 1983?
Act provided incentives for drug companies to produce medications for rare disease which effect ≤ 200,000 Americans
- Tax incentives
- Get 7 years of exclusivity
- Get help with clinical trial design
- Facilitated review
What is the Drug Price Competition and Patent Term Restoration Act also known as?
The Waxman-Hatch law
What is the Drug Price Competition and Patent Term Restoration Act?
It created the Abbreviated NDA aka ANDA process for generic drug approval which also required bioequivalence
What is the 1987 Prescription Drug Marketing Act?
Provided a diversionary market for deeply discounted drugs and samples
- SAMPLES
- Resale by health care entities (hospitals)
- Licensing of wholesalers by states
- made re-importation of drugs from other countries illegal
What is the Prescription Drug User Fee Act aka PDUFA 1992
Allowed fees for review for NDA
What is the 1994 Dietary Supplement Health Education Act (DSHEA)?
It distinguished a many class of products from regulation by the FDA
What is the 2007 FDA Amendments Act?
- Created the REMS program (Risk Evaluation and Mitigation Strategy)
- Labeling changes to add “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800FDA1088”
- Also gave FDA authority to regulate drugs post-market
What is the 2012 FDA Safety and Innovation Act aka FDASIA?
Expanded the PDUFA not only for NDA but also added for devices, generic and bio-similar agents
What is the Drug Quality and Security Act of 2013?
Title 1:
- Created “Outsourcing Facilities” from more traditional compounders (gave pharmacist to ability to compound without the FDA monitoring every product)
- Compounding in absence of Rx or “reasonable anticipation”
- Traditional compounding is preserved
Title 2: Track and Trace program
Who appoints the Commissioner of the FDA?
Appointed by the President
and
Confirmed by the Senate
(Steven Hun is the name of the new Commissioner)
What is the CBER?
Biologics evaluation and research center of excellence within the FDA
What is the CDER?
Drug evaluation research center of excellence within the FDA
What authority dose the FDA have?
- Issuing or withdrawing licenses
- Rulemaking
- Issuing warning letters
- Publish guidance document (not legally binding tho, just guidance): “compliance police guides”
- Power to inspect
- New safety tools via FDAAA 2007
What dose the Food, Drug and Cosmetics Act do?
A Criminal statute which prohibits:
- The exchange of “Adulteration” and “Misbranding” products in interstate commerce
- The sale/exchange of unapproved ‘new’ drug
- The sale/exchange of unsafe dietary supplements
What is the FDA’s enforcement powers?
They can:
- Bring an injunction (get a court order for a manufacturer to cess and desist)
- Bring criminal, felony proceedings (fines/imprisonments)
- Seize products
- Issue warning letters
- Recall products and can assign classes to the severity of the recall
Class I: reasonable probability of ADE
Class II: temporary of medically reversible ADE
Class III: not likely to cause ADE
What is the definition of Drug?
A - Articles recognized in the official USP, HPUS, NF …
B - Articles intended for the use in the diagnosis cure, mitigation, treatment, or prevention of disease
C - Articles other than food intended to affect the structure or any function of the body
A, B, and C are all separate definition. Any one of them or a combination of them is a definition drug.
To be considered a drug, it must go through the approval process
What is the definition of New Drug?
A drug not generally recognized as safe and effective (“GRASE”)
It is a federal crime to introduce a “new Drug” into the interstate commerce without FDA approval
Drugs per-1938 were ‘grandfathered’ but have received FDA approval since and so no drugs have grandfathered status
What is the definition of “Official Compendium”?
Means the official United States
- Pharmacopoeia
- Homeopathic Pharmacopeia of the United States
- National Formulary
- Any supplement to any of the above
True or False: By definition dietary supplements are not drugs per FDA.
True
To be considered a drug, it must go through the approval process
Dietary supplements does not need to be FDA regulated to be in market . HOWEVER, GMPs now also required in production of dietary supplement.
True or False: By definition dietary supplements are not drugs per FDA.
True
To be considered a drug, it must go through the approval process
Dietary supplements does not need to be FDA regulated to be in market . HOWEVER, GMPs (good manufacturing practices) is required in production of dietary supplement.
**What is the definition of Adulteration?
- If it has an filthy, putrid, or decomposed substance
- If it has been packed or held under insanitary condition and not conformed to current good manufacturing practice (CGMP)
- If its strength differs from or its quality or purity falls below the standard
- If its mixed or packed in any way so to reduce its quality or strength
What is the definition of Misbranding?
Anything that has to do with LABELING or DISPENSING requirement breech
- If its labeling is false or misleading
- If the name and please of business, manufacture is inaccurate
- If active and inactive ingredients are not present
- if is doesn’t have adequate direction for use
- If the drug has the tendency to deteriorate and that fact is not on the label
and so so so much more
Misbranding and Packaging examples (as influenced by Durham-Humphrey)… (4)
- CRP (Child-resistant packaging)
- Tamper-resistant/tamper evident
- OTC products: adequate directions for use
- Rx products: adequate information for use
What is the definition of ‘Label’?
A display of written, printed or graphic matter on the Immediate Container (could be OTC bottle label, prescription bottle label, prescription drug stock bottle labels)
What is the definition of ‘Labeling’?
Includes label and written/printed/graphic material that Accompanies the product. Such as:
- PI, PPIs, MedGuides, brochures
What is the difference between the requirement for OTC labels vs Rx labeling?
OTC labels: Adequate directions for use
Rx labeling: Adequate information for use
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