FDCA Amendments simplified! Flashcards
(33 cards)
Food Drug and Cosmetic Act did what
1- A drug has to be proven safe and effective for use before it is marketed and sold
2- has to be proven by the Food and Drug Administration (FDA)
3- forms the nucleus for today’s laws
Pure Food and Drug Act
What does adulteration mean
1- Put in place due to concern for unsanitary and poorly labeled foods and drugs given to the public
2- issued by Congress
3- It prohibited the adulteration and misbranding of foods and drugs in interstate trading
Sulfanilamide elixir tragedy
what are sulfa drugs
1- what is it: Sulfanilamide was one of the first of the “miracle” anti-infective sulfa drugs sold
2- What happened: Because it smelled bad, the manufacturer produced the drug in an elixir form with diethylene glycol (like antifreeze for cars; a poison) and did not test for toxicity and poison
3- Removed from the market: The 1906 law did not grant the FDA the authority to ban unsafe drugs. So the FDA removed the elixir on a technicality: Elixirs must contain alcohol, and the elixir of sulfanilamide did not contain alcohol so it was removed
Sulfa drugs are used to treat bacterial infections
FCDA Label Policy & Durham-Humphrey Amendment ***
1- Labels must have directions for use and warnings about the habit-forming properties of drugs.
2- This applies to cosmetics and devices as well.
3- Drugs on the market at this time were not safe for use except under medical supervision.
What two things did the Durham-Humphrey Amendment do and what would happen if prescription drugs had “caution: Federal law prohibits dispensing without a prescription” ***
1- Established two classes of drugs
prescription and over-the-counter
2- Labels of prescription drugs do not need to contain “adequate directions for use” as long as they have “Caution: Federal law prohibits dispensing without a prescription”
Durham-Humphrey Amendment is satisfied by what and authorizes what **
1- The label for “adequate directions of use” is satisfied by a pharmacist putting the label of directions from the prescriber
2- Authorizes oral prescriptions (giving prescriptions by word of mouth) and refills of prescription drugs
Congress amended the FDCA to include what and prohibit what for which clause
1- Congress required the FDCA to require that food ingredients must be approved for safety before going on the market
2- prohibits food additives that might cause cancer- Delaney clause
Color Additive Amendments require what from manufacturers and can the FDCA approve colors for every food **
1- Requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics.
2- The FDA can approve a color for one use but not the others (e.g. external use only)
Thalidomide
What did thalidomide cause
What did the FDA withhold approval of
Did the FDA allow thalidomide to be sold in the U.S.? What was the result of this?
What amendment resulted from this?
What did the amendment do?
1- thalidomide caused birth defects, in thousands of infants. The FDA withheld final approval of the new drug application (NDA) pending safety information.
2- The FDA did not allow it to be sold in the US so the number of birth defects in the US was low.
3- Congress enacted the Kefauver-Harris Amendment: Manufacturers must prove the effectiveness of drug products before they go on the market, and afterward report any serious side effects
What is the Kefauver-Harris Amendment
What did the FDA gain control of
What did the GMP do ***
1- required drugs to be proven not only safe but also effective.
2- Place control of prescription drug advertising from the Federal Trade Commission to the FDA
established
3- Good Manufacturing Practices (GMP)
added more extensive controls for clinical investigations, informed consent, and reporting of adverse drug reactions
What did the Medical Device Amendment restrict the FDA from doing
What did Congress do to the FDCA later on ***
1-The FDA could not review medical devices for safety and efficacy before marketing
2- Congress amended the FDCA to provide more extensive regulation and administrative authority regarding the safety and efficacy of medical devices.
What does the Medical Device Amendment require ***
1- Classification of devices according to their function
2- premarket approval
3- Establishment of performance standards
4- Conformance with GMP regulations
5- Adherence to record and reporting requirements
Orphan Drug Act?
What did pharm. companies tell Congress about NDA
What did Congress do about it? ***
1- Pharm. companies told Congress that the NDA process was too expensive to make drugs for diseases that affected a few people.
2- Congress provides tax and exclusive licensing incentives for companies to develop and market these drugs– so this is the Orphan Drug Act :)
What is an Orphan Drug? ***
drugs for “rare diseases or conditions” (defined as those affecting fewer than 200,000 Americans.)
What is the Drug Price Competition and Patent Term Restoration Act also known as
What did it do ***
1- Waxman-Hatch Amendment
2- to make generic drugs more available to the public while providing incentives to manufacturers to develop new drugs.
What did the Prescription Drug Marketing Act do?
What did it prohibit
What does it require
What was the fear that put this amendment in pace
1- Prescription drug samples will have sales restrictions and record-keeping requirements
2- Prohibits hospitals and other healthcare entities from reselling their drugs
3- Other businesses require state licensing of drug wholesalers.
4- A secondary distribution system for prescription drugs was threatening public health and safety and creating an unfair form of competition.
What did the Safe Medical Devices Act do for the FDA
1- Made the FDA have additional authority for post-marketing requirements and premarket notification
2- also allowed for approval while speeding up the premarket device approval process.
How did the Generic Drug Enforcement Act occur
What did the FDA do in response to convicted felonies?
what is the consequence for false statements, brides, etc **
1- Occurred when some FDA staff accepted bribes from generic drug industry workers to facilitate the approval process of certain generic drug products.
2- The FDA banned individuals or firms from participating in the drug approval process if convicted of related felonies.
3- Impose severe civil penalties for any false statements, bribes, failures to disclose material facts and other related offenses.
Prescription Drug User Fee Act
What did the FDA and Congress say private industry should do
What do manufacturers have to pay for
What does the FDA do with the money from the companies ***
1- The FDA and Congress took the approach that private industry should handle part of the costs for new drug approval rather than the taxpayers.
2- Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies.
3- Fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA review.
What does the Nutrition Labeling and Education Act
mandate as long as it meets FDA regulations
1- Nutrition labeling on food products
2- Health claims on product labeling
Why is the Dietary Supplement Health and Education Act (DSHEA) in place
What does DSHEA define and permit
How does the FDA regulate dietary supplements
1- Dietary supplement manufacturers felt that the NLEA left too much authority with the FDA and restricted the promotion of dietary supplements.
2- DSHEA defines dietary supplements and permits manufacturers to make certain claims that otherwise would have been illegal under the FDCA
3- The FDA regulates dietary supplements more as foods than as drugs.
What is a Dietary Supplement?
What does it contain
What does a dietary supplement do
1- A product that is intended: for ingestion; To supplement the diet
2- Contains any one or more of the following:
a vitamin
a mineral
an herb or other botanical
an amino acid
3- A dietary substance for use by humans to supplement the diet by increasing the total dietary intake
a concentrate, metabolite, constituent, extract, or combination of the previous
Dietary Supplement claim
What can manufacturers do to link food and disease?
What does the manufacturer have to do to make claims?
How did the FDA relax the standard for evaluation?
1- Manufacturers may make limited health claims for dietary substances that describe the relationship between a food substance and a disease.
“Folic acid may reduce the risk of neural tube birth defects”
2- To make the claims, the manufacturer must receive FDA approval for the health claim as judged by the “significant scientific agreement” standard.
3- Today, the FDA has appeared to relax its standard for evaluation, stating it would approve such claims if the scientific evidence in support of the claim outweighs the evidence against the claim.
Food and Drug Administration Modernization Act (FDAMA)
What was the FDA accused of and was the FDCA burdensome
What did the FDAMA do for regulatory procedure
1- Due to FDA criticism, the FDA was not efficiently administrating its statutory responsibilities, and the FDCA was too burdensome a regulatory system for drug approval.
2- FDAMA passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices.
