511 - Pharm Law - Exam I - New Drugs And Advertising

Front 1

What is required under (Section 505(b)) in regards to a NDA?

Back 1

1) Full reports of investigations showing the drug's safety and efficacy
2) It's components and composition
3) The methods, facilities and controls used in manufacturing, processing and packaging of the drug
4) Samples of the drug and its components
5) The proposed labeling of the drug

Front 2

What is the formal description of a new drug under Section 201(p) in the FDCA?

Back 2

"... as a drug that is not recognized by qualified experts as safe and effective for use under the conditions recommended in the drug's labeling."

Front 3

Under what circumstances is a drug exempt from proving safety or efficacy?

Back 3

This applies to drugs marketed before 1938 providing it is marketed in accordance with requirements as were current as this time

Front 4

Define: "NDA"

Back 4

New Drug Application

The process by a which a drug goes through a regulatory panel ensuring safety and efficacy of the drug for therapeutic use

Front 5

Define: "GRASE"

Back 5

Generally Recognized As Safe & Effective

A manufacturer can declare a drug GRASE to attempt to bypass a NDA

Front 6

Under what circumstances can an approved drug become a new drug?

Back 6

1) The drug contains a new substance
a) Either API, excipient, carrier or coating
2) There is a new combination of approved drugs
3) The proportion of ingredients in combination is changed
4) There is a new intended use for the drug
5) The dosage, method or duration of administration or application has changed
a) Ex: A change from capsule to injectable delivery

Front 7

Define: "IND"

Back 7

Investigational New Drug

A step below a formal NDA, in which the manufacturer receives permission to conduct clinical studies of a new drug. The IND must demonstrate that the drug has potential merit and would be reasonably safe to test in humans.

Front 8

What are the legal requirements for an IND?

Back 8

The sponsor must submit information such as:
1) Name of the drug
2) Its composition
3) Methods of manufacture and quality control
4) Information from preclinical (animal) investigations regarding pharmacological, pharmacokinetic and toxicological evaluations
5) Experience and qualifications of the clinical investigators

Front 9

Describe "Phase I" of the NDA process

Back 9

Usually involves a small number of patients, investigators look at toxicity, metabolism, bioavailability, elimination and other actions in order to determine any adverse effects, not for efficacy.

Initial doses are started low, and then increased

Front 10

Describe "Phase II" of the NDA process

Back 10

Testing of the compound begins on patients who actually have the disease to determine total efficacy of the compound as well as dose ranges.

Front 11

Describe "Phase III" of the NDA process

Back 11

Continuation of Phase II, except the study is conducted in hundreds or thousands of patients, usually in an actual clinical setting.

Studies are usually double-blind, with a control group receiving a placebo.

Front 12

When can a manufacturer submit a NDA to the FDA for approval?

Back 12

Only after successful completion of Phase III trials

Front 13

Define: "Informed Consent"

Back 13

Requires that potential participants know the risks, possible benefits and alternative courses of treatment. Consent must be given in writing during phases I/II, but can be given orally in phase III

Front 14

How many days does the FDA have to act on a completed NDA?

Back 14

180 days... but delays are common

Front 15

What is the Prescription Drug User Fee Act of 1992 and how does it affect the approvals process?

Back 15

This fee allows the FDA to collect fees from manufactures during the NDA process

This allows the FDA to higher additional reviewers which decreases approval wait time, while also discouraging NDA submission until they have a high probability of success.

Front 16

Define: "Post-marketing Surveillance"

Back 16

A legal requirement which states that the manufacturer maintain and establish postmarketing records and reports for a drug. This can pertain to:
1) serious ADRs,
2) new information pertaining to safety and efficacy
3) current clinical studies
4) labeling
5) advertising
6) quantity distributed

Front 17

Describe "Phase IV Studies"

Back 17

A type of postmarket clinicial study to determine new uses or abuses for a drug or obtain additional safety and efficacy data

Front 18

Define: "ANDA"

Back 18

Abbreviated New Drug Application

Created as a means to approve generic drugs without filing a full, formal NDA. It states that proof of safety and efficacy is not required, but only proof of bioequivalence and proofs of acceptable manufacturing methods and controls

Front 19

How is bioequivalence established?

Back 19

Usually through evidence from human clinical trials which show that the drug's Cmax and AUC are not significantly different from the branded drug

Front 20

Under what conditions will the FDA approve an investigational drug for treatment?

Back 20

1) It is to be used for a serious or immediately life-threatening disease or condition
2) there is no comparable or satisfactory alternative therapy available
3) The drug is under investigation for the disease or condition
4) The sponsor is actively pursuing marketing approval of the drug
5) There is sufficient evidence of safety and effectiveness for the use in serious diseases
6) In life-threatening diseases, a reasonable basis that the drug may be effective and not expose the patient to undue risk

Front 21

In an IND a number is assigned per chemical type. List the numbers and what they mean.

Back 21

1) New Molecular Entity
2) New ester, new salt, or other non-covalent derivative
3) New formulation
4) New combination
5) New manufacturer
6) New indication
7) The drug is a product previously marketed by the same firm, but w/o an approved NDA

Front 22

For an IND a letter is assigned per therapeutic potential. List those letters and what they mean.

Back 22

P - Priority Review: 6 months, used for products that offer significant improvements compared to marketed products
S - Standard Review: 10 months
O - Orphan Designation

Front 23

Define: "DESI"

Back 23

Drug Efficacy Study Implementation

Initiated in 1962, the FDA classified generic drugs as new drugs and required their efficacy proven. Lead to the creation of the ANDA.

Front 24

Define: "Parallel Track Policy"

Back 24

Individual Patient Access to Investigational Drugs for Serious Diseases

Allows patient and physician to use a non-approved therapy still in study providing it does not increase risk to the patient's health while possibly offering benefit

Front 25

Define: "Fast-Track Approval"

Back 25

Expedited Approval fo Drug Intended to Treat Life-Threatening Illnesses

Usually occurs if both:
1) The treatment demonstrates a potential to address unmet medical needs for a condition
2) The effect on a clinical endpoint is reasonably likely to predict clinical benefit

Front 26

What two federal agencies regulate drug advertising?

Back 26

FDA & FTC

Front 27

What must be contained in the "true statement" in advertising from manufacturer to professionals?

Back 27

1) Established name of the drug
2) Formula, showing ingredients
3) Brief summer of side effects, contraindications, effectiveness

Front 28

What is a "reminder advertisement"?

Back 28

Pertains to manufacturer to professional advertising.

"Reminds" the individual of the name of the drug product (via pens, notepads, etc) without including indications or recommendations

Front 29

What are exempt from required "true statements" in advertising from manufacturer to professional?

Back 29

1) Reminder Advertisements
2) Bulk sale drugs
3) Compounding Drugs
4) Or anything as long as no safety or effectiveness claims are made

Front 30

Define: "Fair Balance"

Back 30

This requires that information related to side effects and contraindications is given the same prominence and weight as for its effectiveness

Front 31

What violates the "true statement" in advertising between manufacturer and professionals?

Back 31

1) Misrepresentation of a drug's effectiveness or lack of side effects
2) When it lacks fair balance
3) Failing to reveal material facts
4) Misbranding

Front 32

What is the main difference between advertising and labeling?

Back 32

Both have general standards to meet

Advertising only requires a "brief" summary and a modification of the true statement requirements in broad cast media.

Labeling must contain the entire package insert and is found most often in brochures, booklets, mailing pieces, etc

Front 33

Are the laws different for advertising from Manufacturer-to-Professionals and Manufacturer-to-Consumer (DTC)?

Back 33

No, they are the same

Front 34

Why is it hard to meet the "true statement", "brief summary" and "fair balance" in DTC ads?

Back 34

The length of the advertisement as well as differing amounts of patient knowledge prove difficult to inform all patients completely

Front 35

Define: "Adequate Provision"

Back 35

Requirement for brief summary for consumer to obtain full labeling from four sources:
1) Toll-Free number
2) Website
3) Referral to a concurrent print publication
4) Referral to a health care provider

Front 36

What form of DTC ads does not require a "Brief Summary"?

Back 36

Print ads

Front 37

What are the three categories of DTC advertising?

Back 37

1) Product Claim Ads
2) Reminders Ads
3) Help-seeking ads

Front 38

Define: "Off-label"

Back 38

Using a drug product for an indication other than those approved by the FDA

Front 39

When does the FTC decide an advertisement is deceptive?

Back 39

This occurs when the advertisement contains a statement or omission of information that is likely to mislead consumers to their detriment

Front 40

What act regulates non-prescription drug advertising and who enforces it?

Back 40

It is regulated by the Federal Trade Commission Act and is regulated by the FTC

Front 41

Define: "Lanham Trademark Act"

Back 41

This act prohibits the misuse or representation of words or symbols in connection with the sale of any goods or services.

Manufactures often use this to sue another manufacture for false advertising claims