FDCA Amendments simplified!

Question 1

Food Drug and Cosmetic Act did what

Answer 1

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

Question 2

Pure Food and Drug Act

What does adulteration mean

Answer 2

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

Question 3

Sulfanilamide elixir tragedy

what are sulfa drugs

Answer 3

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

Question 4

FCDA Label Policy & Durham-Humphrey Amendment ***

Answer 4

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.

Question 5

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” ***

Answer 5

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”

Question 6

Durham-Humphrey Amendment is satisfied by what and authorizes what **

Answer 6

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

Question 7

Congress amended the FDCA to include what and prohibit what for which clause

Answer 7

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

Question 8

Color Additive Amendments require what from manufacturers and can the FDCA approve colors for every food **

Answer 8

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)

Question 9

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?

Answer 9

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

Question 10

What is the Kefauver-Harris Amendment
What did the FDA gain control of
What did the GMP do ***

Answer 10

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

Question 11

What did the Medical Device Amendment restrict the FDA from doing
What did Congress do to the FDCA later on ***

Answer 11

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.

Question 12

What does the Medical Device Amendment require ***

Answer 12

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

Question 13

Orphan Drug Act?
What did pharm. companies tell Congress about NDA

What did Congress do about it? ***

Answer 13

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 :)

Question 14

What is an Orphan Drug? ***

Answer 14

drugs for “rare diseases or conditions” (defined as those affecting fewer than 200,000 Americans.)

Question 15

What is the Drug Price Competition and Patent Term Restoration Act also known as
What did it do ***

Answer 15

1- Waxman-Hatch Amendment

2- to make generic drugs more available to the public while providing incentives to manufacturers to develop new drugs.

Question 16

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

Answer 16

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.

Question 17

What did the Safe Medical Devices Act do for the FDA

Answer 17

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.

Question 18

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 **

Answer 18

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.

Question 19

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 ***

Answer 19

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.

Question 20

What does the Nutrition Labeling and Education Act
mandate as long as it meets FDA regulations

Answer 20

1- Nutrition labeling on food products
2- Health claims on product labeling

Question 21

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

Answer 21

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.

Question 22

What is a Dietary Supplement?
What does it contain
What does a dietary supplement do

Answer 22

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

Question 23

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?

Answer 23

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.

Question 24

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

Answer 24

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.

Question 25

What is the intent of the Food and Drug Administration Modernization Act intent
what does the intent result in

Answer 25

1- The intent is to eliminate backlogs in the approval process and ensure timely review of applications.

2- Creates fast fast-track approval process for drugs intended for serious or life-threatening diseases

3- Establish a database of information on clinical trials, authorize scientific panels to review clinical investigations, and expand the rights of manufacturers to disseminate unlabeled use information.

4- Expands the FDA’s authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients.

Question 26

What did the Medical Device User Fee and Modernization Act establish

Answer 26

1- Established user fee requirements for premarket reviews of medical devices

2- Established performance goals for many types of premarket reviews, and inspections that can be conducted at establishments by accredited third parties

3- New regulatory requirements for reprocessed single-use devices. This also must be renewed by Congress every 5 years.

Question 27

Food and Drug Administration Amendments (FDAAA)
What was the result of PDUFA
What did the postmarket problems provide the FDA
What does the

Answer 27

1- FDA’s broader use of the fees generated from PDUFA, substantially increased fees

2- In response to postmarket problems with certain drug products (i.e. Vioxx), the law provides the FDA with increased responsibilities and authority to regulate drug safety, label changes related to safety, clinical trial data reporting, and registries, requiring postmarket clinical studies to assess risk

3- requires companies to implement risk evaluation and mitigation strategies (REMS).

Question 28

What does the FDA Safety and Innovation Act allow
What does it add
what is the purpose of imposing fees on manufacturers

Answer 28

1- allows the FDA to continue to collect fees from manufacturers seeking NDAs or medical device approvals.

2- It also adds the Generic Drug User Fee Act and Biosimilar User Fee Act.

3- The purpose of imposing fees on these manufacturers is to increase resources for the FDA in order to speed up the generic drug and biosimilar approval process

Question 29

What does the FDA Safety and Innovation Act do concerning drug counterfeiting?

Answer 29

1- enables the FDA to inspect foreign drug manufacturers more regularly and requires the agency to target problematic manufacturing sites.

Question 30

what is the first title of the Drug Quality and Security Act
what is it also called ***

Answer 30

1- clarifies and strengthens FDA oversight over pharmacies engaged in the large-scale compounding and shipping of sterile products to other licensed entities.

2- The law also removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMP, labeling and the new drug approval process.

3- title 1 also called the Compounding Quality Act

Question 31

what is the 2nd title of the Drug Quality and Security Act
what is it also called

Answer 31

1- adds “track and trace” requirements for all entities in the chain of distribution of pharmaceutical products.

2- Requires manufacturers to provide transaction information to purchasers, who in turn must provide transaction information to subsequent purchasers.

3- The law also mandates an electronic, exchangeable product tracing system by 2023, strengthens wholesaler and third-party logistics licensure requirements, and requires manufacturers to serialize drugs by 2017.

4- Title II known as the Drug Supply Chain Security Act,

Question 32

Why was the 21st Century Cures Act passed?

Answer 32

1- to streamline and add flexibility and innovation to the drug development and approval process, by creating new clinical trial design options and by accelerating the pathways to market for drugs intended to treat certain serious or life-threatening diseases.

2- provides for billions of dollars of additional funding to the National Institute of Health (NIH).

Question 33

what does the FDA Reauthorization Act do

Answer 33

1- Reauthorized the user fee programs

2- Enhanced the goals of the Cures Act

3- created a new category of OTC hearing aids.