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Federal Law > Drug Development and Regulation of New Products > Flashcards

Drug Development and Regulation of New Products Flashcards

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1
Q

What do you call a drug not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug’s labeling? Even if the drug is recognized, it must also have been used to a material extent or for a material time under the conditions recommended in the labeling

A

New drug

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2
Q

GRASE stands for?

A

Generally recognized as safe and effective

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3
Q

Drugs may be considered new if (5 reasons)

A
  1. The drug contains a new substance
  2. It 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 is changed
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4
Q

What does INDA stand for?

A

Investigational new drug application

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5
Q

What are the components of an INDA?

A
  1. Proposal such as drug information (name, composition, methods of manufacture and quality control, information from preclinical investigations regarding pharmacological, pharmacokinetic, and toxicological evaluations and investigator/investigation information (experience and qualifications of clinical investigators, outline of proposed clinical trials)
  2. Testing - 3 phases where you must obtain informed consent from patents/representatives
  3. Public registry of clinical trials - NDA sponsors must publish summary info about any post phase 1 clinical trial on public registry
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6
Q

Phase 1 and 2 of clinical trials requires what type of consent?

A

Written consent

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7
Q

Phase 3 permits what type of consent?

A

Oral consent is permitted if physician decides it is necessary or preferable to written consent and consent is documented in medical chart

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8
Q

What type of clinical phase of the INDA is:
SAFETY - detect ADE (toxicity, metabolism, bioavailability, elimination, pharmacological actions), does not test efficacy

A

Phase 1

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9
Q

What type of clinical phase of the INDA is:

EFFICACY - determines efficacy of the drug and the dosages at which efficacy occurs

A

Phase 2

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10
Q

What type of clinical phase of the INDA is:

Safety and efficacy in hundreds or thousands of patients (double blind placebo control)

A

Phase 3

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11
Q

Drug manufacturers must apply for and receive FDA approval of a ____ before it can be sold and marketed

A

New drug application (NDA)

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12
Q

What are the required information in an NDA application?

A
  1. Full reports of clinical investigations showing the drug’s safety and efficacy
  2. The drug’s components and composition
  3. The methods, facilities, and controls used in manufacturing, processing and packaging the drug
  4. Samples of the drug and its components
  5. The proposed labeling of the drug
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13
Q

How long does the FDA have to look at an NDA?

A

180 days but delays are common

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14
Q

What is the median approval time of an NDA?

A

15 months

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15
Q

What influences the length of the NDA review process?

A

FDA’s Rating and Classification system

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16
Q

What does the FDA drug rating and classification system indicate?

A

the number indicates drug’s chemical type and a letter indicates its therapeutic potential

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17
Q

What are examples of chemical types that the FDA can rate?

A

i. new molecular entity
ii. new active ingredient
iii. new dosage form
iv. new combination of compounds
v. new formulation or new manufacturer
vi. new indication - drug product previously marketed by the same firm
vii. drug already marketed without an approved NDA
viii. OTC switch
ix. new indication submitted as distinct NDA consolidated with original NDA after approval
x. new indication submitted as a distinct NDA, not consolidated

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18
Q

What does a therapeutic potential P mean?

A

Priority, the drug represents a therapeutic advance for one of the following reasons: no other effective drugs are safe, is more effective or safe than drugs currently used, has important advantages such as greater convenience, reduced side effects, or improved tolerance or usefulness in special populations

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19
Q

What does a therapeutic potential S mean?

A

Standard, similar to those drugs already on the market and at best only offers minor improvements

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20
Q

What does a therapeutic potential O mean?

A

Orphan, rare disease affecting <200,000

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21
Q

What does a manufacturer need to submit if they want to make any changes in the drug or its production, even minor ones, after approval of an NDA?

A

Supplemental NDA

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22
Q

Which supplemental NDA procedure allows sponsors to make changes to their product before FDA approves it?

A

Change Being Effected (CBE) supplement - includes certain types of labeling changes like strengthening warnings or dosage and administration information, or for certain changes n manufacturing methods, facilities, and controls

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23
Q

Which supplemental NDA procedure does not allow sponsors to make any changes before the FDA approves?

A

Prior Approval Required for production changes - changes range from synthesis of drug to manufacturing process of the drug to the labeling of the drug

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24
Q

What supplement NDA procedure allows sponsors to only report in the annual report to the FDA?

A

Minor changes - editorial changes in labeling or changes in container size

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25
Q

What is post market surveililance?

A

Once an NDA has been approved, manufacturer may distribute drug in interstate commerce
Must maintain and establish post-marketing records and reports and must submit reports of any serious ADR and any new information relating to the drug’s safety and efficacy

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26
Q

Can the FDA withdraw approval for an NDA during post market surveillance?

A

Yes, if the investigational drug is tested in a small number of patients compared to the population or if long term adverse effects are discovered after approval

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27
Q

In what phase do manufacturers engage in post market clinical studies?

A

Phase IV - this is when they determine new uses or abuses for a drug and obtain additional safety or efficacy data for labeled indications

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28
Q

Which amendment granted the FDA agency authority to require phase IV?

A

Food and Drug Administration Amendments Act

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29
Q

What can the FDA require a drug product sponsor to sign-up for in order to establish special procedures directed at patient safety so that potential serious risks of the drug product are managed?

A

Risk Evaluation and Mitigation Strategy (REMS) program

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30
Q

When can the FDA require REMS?

A

pending NDA or they can mandate a REMS post-market, when FDA believes it necessary to ensure the benefits of the drug outweigh the risk

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31
Q

What do drug sponsors need to submit to show whether the drug’s risks are being adequately managed?

A

Periodic post-market assessments

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32
Q

What are the potential procedures required under REMS?

A
  1. Distribution of Medication Guides
  2. Patient PI
  3. Communication plan aimed at health care professionals
  4. ETASU - elements to assure safe use
  5. May require that health care providers have special training or experience, drug may only be dispensed in specific settings, and/or that the patient enroll ini a registry and agree to testing and monitoring
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33
Q

What is post market labeling?

A

Prior to FDAAA, the FDA didn’t have authority to require manufacturers to include additional safety information or warnings in labeling after a drug was marketed. Now they can compel to change safety related labeling

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34
Q

What is the proactive surveillance system designed to detect early signs of medication risk and safety problems by querying broad arrays of information data sources like EHRs, insurance claims databases?

A

Sentinel Initiative

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35
Q

What are the efforts FDA will undertake to communicate risks to, commonly, pharmacists?

A

Risk communication strategic plan

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36
Q

This program was implemented in response to the Kefauver-Harris Amendment requiring drugs to be effective as well as safe

A

Drug Efficacy Study Implementation Program (DESI): FDA retroactively treated generic drugs as new drugs and required manufacturers to prove efficacy

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37
Q

Under the Drug Efficacy Study Implementation Program (DESI), thousands of drugs approved between 1938 and 1962 were categorized into one of the six categories:

A
  1. Effective
  2. Probably effective
  3. Possibly effective
  4. Ineffective
  5. Effective, but
  6. Ineffective as a fixed combination
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38
Q

DESI created the Abbreviated New Drug Application (ANDA). What is it?

A

proof of safety and efficacy NOT REQUIRED, but rather only proof of BIOEQUIVALENCE and proof of acceptable manufacturing methods and controls

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39
Q

This Act allowed generic manufacturers not to have to duplicate actual research establishing safety and efficacy of innovator drug, but submit on the basis of published scientific data

A

Drug Price Competition and Patent Term Restoration Act (PTRA) or aka Hatch-Waxman Act

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40
Q

(T/F) The Drug Price Competition and Patent Term Restoration Act (PTRA) statutorily created the ANDA process where manufacturer only had to prove bioequivalence and acceptable manufacturing methods and controls

A

True

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41
Q

The PTRA allows FDA to grant innovator drugs what benefits?

A
  • Patent term extensions as long as patent has not expired
  • Market exclusivity for an innovator manufacturer that develops a new chemical entity or a new use for a previously approved drug (new chemical entities have 5 years from the approval of the drug and new uses have 3 years)
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42
Q

What do generic manufacturers need to make to obtain approval for an ANDA?

A

Patent certification, there are 4 types:

  1. NDA holder didn’t file information on the patent to the FDA (so no patent)
  2. The patent already expired
  3. The date the patent will expire
  4. The patent is invalid or will not be infringed upon by the manufacture, use, or sale of the generic applicant’s drug (applicant must notify patent owner and NDA holder citing factual and legal basis for why patent is invalid or FDA cannot approve ANDA for 30 months unless a court issues final ruling that patent is invalid before 30 months is up)
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43
Q

Law allows generic to statistically vary in rate and extent of absorption by how much percent from an innovator drug?

A

+/- 20% (there could be a 40% difference in blood level between a generic and innovator in the course of 2 months of therapy resulting in adverse clinical outcomes)

44
Q

What is the average difference in the data analysis of generic and innovator drugs?

A

Average difference is 3.5% which shouldn’t produce clinical differences

45
Q

Can generics be dispensed for indications that the innovator had been granted market exclusivity?

A

Yes, if the generic writes it off as an off-label use (ex. generic propranolol for post-MI when innovator brand propranolol has marketing exclusivity for this condition)

46
Q

Can the FDA approve ANDA for a generic drug when the labeling of the generic drug won’t include all conditions/indications listed for the innovator drug?

A

Yes, the generic labeling can still be effective and safe without all listed indications. And because new generic drugs could be delayed, innovator drug manufacturers could strategically file for supplemental indications every 3 years to delay generic manufacturing

47
Q

What are “authorized generics”?

A

It is when innovator drug manufacturers will produce a generic version of brand name product just as patent is about to expire or be successfully challenged (innovators are allowed to do this without an ANDA)

48
Q

When a patent holders sues generic for patent infringement, how long do generics stay in ANDA approval?

A

30 months - many manufacturers sue to obtain the 30 month exclusivity even though they have very weak legal positions and little chance of prevailing

49
Q

(T/F) Secondary patents can be made that cover manufacturing processes, methods of use, and new tablet coatings

A

True

50
Q

What is “product hopping”?

A

When patent nears the end, manufacturers will change its product to ER, different salt, to secure additional patent

51
Q

Why would a 505(b)(2) application be filed?

A
  1. Manufacturer of a drug approved under previous NDA might use this pathway to receive approval for new indications, relying on the safety data of previous NDA
  2. Generic manufacturers might use this pathway instead of a full NDA when the generic product can’t be approved under an ANDA because of significant changes from the reference product in terms of different formulation, route of administration, or delivery mechanism
52
Q

Did OTC drugs have to under review because of the DESI program?

A

Yes, after reviewing prescription drugs, the FDA began reviewing OTCs marketed between 1938 and 1962.

53
Q

How were OTC drugs evaluated in the DESI program?

A

Evaluated based on therapeutic categories and classified through rule making rather than individually. Nearly all OTCs had been prepared from only about 200 active ingredients

54
Q

What was the procedure for OTC drugs under the DESI program?

A
  1. FDA appointed advisory review panel of qualified experts to consider drugs by class (analgesic, antacids, etc.) and to make recommendations
  2. FDA publishes recommendations in Federal Register, requesting public comment
  3. After comments, FDA publishes a proposed rule in Federal Register
  4. FDA publishes monograph, identifying which active ingredients are generally recognized as safe and effective and may therefore be marketed. Monograph specifies labeling. (Products without approved active ingredients or labeling must be removed and, where possible, reformulated and relabeled).
  5. Monograph on reviewed ingredients specifies in which of three categories the ingredient is placed: I (safe, effective, not misbranded), II (not safe, effective and are misbranded), III (data insufficient to permit classification)
55
Q

What is the voluntary reporting program for health care professionals to report any serious adverse events, potential and actual product use errors, and product quality problems related to drugs, biologics, medical devices, special nutritional products, and cosmetics?

A

MetWatch program

56
Q

Are pharmacies required to provide patients with the MedWatch number?

A

Yes, FDAAA broadened the program to include patient reporting

57
Q

(T/F) All marketed drugs have been approved by the FDA

A

False

58
Q

Why and how are some drugs marketed illegally?

A
  1. Until DESI was instituted, FDA had a policy of allowing post 1938 generics to be marketed as not new drugs if the pioneer or innovator drug had a safe marketing history (FDA allowed somme drugs to be marketed that were not identical or similar to other marketed drugs b/c they felt they were not new drugs/or because the agency didn’t take action against them)
  2. Some drugs are still being reviewed under DESI - allowed to market pending review
  3. Some drugs have been determined to lack efficacy after DESI review but haven’t yet been removed from market
  4. Some drugs marketed claim to be grandfathered as pre-1938 drugs but have changed their labeling or composition, thus voiding their exempted status
  5. Some manufacturers market product without approval hoping to escape notice as long as possible
  6. Illegally marketed OTCs either because monographs don’t allow ingredients or because never subjected to OTC DESI review
59
Q

What drugs are prioritized?

A

Those that have a safety risk, lack evidence of effectiveness, and those that involve health fraud

60
Q

What modified the FDCA to state that an investigational drug may be provided for widespread access outside controlled clinical trials to treat patients with serious or immediately life-threatening diseases for which no comparable or satisfactory alternative therapy is available?

A

Food and Drug Administration Modernization Act (FDAMA)

61
Q

When can investigational drugs be used to treat patients?

A

If they are:

  • used for serious or immediately life-threatening disease or condition
  • there is no comparable or satisfactory alternative therapy available
  • the drug is under investigation for the disease or condition
  • the sponsor is actively pursuing marketing approval of the drug
  • in the case of serious diseases, there is sufficient evidence of safety and effectiveness for use
  • in the case of immediately life-threatening diseases, there is a reasonable basis to conclude that the drug may be effective and would not expose patients to unreasonable and significant risk
62
Q

(T/F) Individual patients are not allowed access to investigational drugs for serious diseases

A

False, individual patients acting through a physician may request an investigational drug from a manufacturer if patient has no comparable satisfactory alternative therapy and the risk to the patient from the drug is no greater than the risk from the disease or condition.
FDA must determined that there is sufficient evidence of safety and effectiveness to support its use and that the individual’s use will not interfere with clinical investigations. The sponsor must submit protocol describing drug use.

63
Q

Individuals are allowed to request access to what phase drugs for serious diseases?

A

Phase I drugs

64
Q

What is the FDA Expanded Access Program?

A

Permits patients with life-threatening diseases or conditions who have exhausted approved treatment options to seek access (through their treating physician) to experimental drugs even in Phase I

65
Q

What is the biggest barrier to the FDA Expanded Access Program?

A

FDA cannot compel drug manufacturers to provide IND drugs and many have refused to provide the drugs because of a limited supply, safety concerns because of limited testing, or fear that an adverse event will ultimately jeopardize the drug’s approval

66
Q

(T/F) Federal right to try law amends the FDCA by creating an alternative pathway to investigational new drugs by removing the FDA from the process.

A

True, but some patients may choose to still apply through the FDA

67
Q

What are products that are derived from living organisms, including viruses, therapeutic serums, toxins, antitoxins, vaccines, blood, and blood components, and derivatives applicable to the prevention, treatment, or cure of a disease or condition of humans?

A

Biologics

68
Q

What two acts are biologics regulated under?

A

Public Health Service Act and FDCA

69
Q

Do biologics require premarket approval by FDA and are they subject to FDCA requirements?

A

Yes, FDA will approve a license upon demonstration that the product is safe, pure, potent, and that the manufacturing facility meets required standards

70
Q

What act created a regulatory framework to approve generic biologics or biosimilars?

A

Affordable Care Act

71
Q

What act creates a regulatory framework to facilitate the approval of generic biosimilars?

A

Biologics Price Competition and Innovation Act (BPCIA)

72
Q

What does the Biologics Price Competition and Innovation Act do?

A

Grants FDA authority to determine whether a biosimilar is therapeutically equivalent to a reference biologic and thus can be substituted in the same manner as generic drugs. This is controversial since manufacturing process of biologics is complex and innovating.

73
Q

What act amends the FDCA to establish a comprehensive system of device regulation that establishes classification system, requires premarket testing, and standards of performance?

A

Medical Device Act of 1976

74
Q

Were medical devices marketed before the Medical Device Act permitted to remain on the market pending classification or other type of FDA action?

A

Yes

75
Q

(T/F) Class I medical devices are the most regulated

A

False, they are the least regulated and pose the least potential harm. General controls are adequate to ensure safety and effectiveness. General controls require that device manufacturers register their facility and list their products with FDA, provide pre-market notification in some cases, maintain records and reports and adhere to GMP. Ex. needles, scissors, exam gloves, stethoscopes, toothbrushes

76
Q

(T/F) Class II medical devices have general controls that are sufficient to ensure safety and effectiveness

A

False, general controls alone are insufficient to ensure safety and effectiveness. They must meet specific performance standards before FDA will permit marketing.
Ex. insulin syringes, infusion pumps, thermometers, diagnostic reagents, tampons, and electric heating pads

77
Q

This class of medical devices must have pre-market approval because they are life supporting or life sustaining or they present potential unreasonable risk of illness or injury

A

Class III medical devices
Ex. pacemakers, soft contact lenses, replacement heart valves
Any device not marketed before 1976 initially falls into class III unless the FDA determines that they are substantially similar to a class I or II device

78
Q

Can the FDA reclassify medical devices?

A

Yes

79
Q

Are all medical devices available OTC?

A

No, certain devices are only available by prescription (the ones that have a potential for harm or require collateral measures to ensure their proper use).
Ex. diaphragms, contact lenses

80
Q

Do custom devices have to follow the same requirements as registration, performance standards, and premarket approval?

A

No, BUT they need to conform to GMP and the adulteration and misbranding requirement still apply

81
Q

Do manufacturers have to report to the FDA any death or serious injury that may be related to their products?

A

Yes, if the device presented an unreasonable risk of substantial harm, it may be recalled. FDA can also seize devices, enjoin shipment and withdraw approval

82
Q

(T/F) FDA can require manufacturers to repair devices, replace devices, and refund the purchase price of the device

A

True

83
Q

Device user facilities such as hospitals, ambulatory surgical facilities, nursing homes, or outpatient treatment facilities that are not physicians’ offices must report to who for any death, serious injury, or serious illness that may be related to the product?

A

Secretary of Health and Human Services

84
Q

(T/F) Distributors also have to notify the Secretary of Health and Human Services of any death, serious injury, or serious illness related to the product

A

False, distributors used to have to notify but the FDAMA removed that requirement and now they just have to maintain records of adverse events

85
Q

(T/F) Cosmetics have the same legal requirements that drugs and devices have

A

False, they do not require premarket approval, although manufacturers must substantiate the safety of their cosmetic products and each of its ingredient

86
Q

What display must be on a cosmetic if the substantiation of safety is not available?

A

“Warning - the safety of this product has not been determined” or the product will be considered misbranded

87
Q

(T/F) Cosmetics do not have to conform to GMP or registration with the FDA

A

True

88
Q

Can the FDA remove a cosmetic from the market if it is misbranded or adulterated or determined to be health hazard?

A

Yes, cosmetic must provide accurate labeling, be clear enough to be read and understood by the ordinary customer, and conform to the Poison Prevention Packaging Act, and not be poisonous or contaminated

89
Q

What are the labeling requirements for cosmetics?

A

List of ingredients in descending order of predominance on the outside of packaging or container. Some must have specified warning statements such as pressurized containers

90
Q

What are the two agencies responsible for drug advertising?

A

FDA - regulates prescription drug advertising under the FDCA

Federal Trade Commission (FTC) - regulates nonprescription drugs under the FTC Act

91
Q

What does the Lanham Trademark Act do?

A

Allows private parties a cause of action against false and misleading advertising - at that state level most pharmacy practice acts prohibit pharmacists from false, misleading or deceptive advertising

92
Q

A drug shall be deemed misbranded unless the manufacturer includes in all advertisements and other descriptive printed matter issued a true statement of:

A
  • Established name of drug
  • Formula showing quantitatively each ingredient
  • A brief summary of other information relating to side effects, contraindications, and effectiveness
  • Statements that are not false or misleading, are a fair balance between side effects and contraindication information and effectiveness information, and reveal material facts
93
Q

What are the two exceptions for advertising regulation?

A
  1. Reminder advertising where it calls attention to the name of the drug product but does not include indications or dosage recommendations for use of product
  2. Advertisements of bulk sale drugs or prescription compounding drugs as long as no safety or effectiveness claims are made
94
Q

Advertising vs labeling

A

Advertising: journal and other periodical ads, media ads, telephone communications; only contains brief summary of risks
Labeling: brochures, booklets, mailing pieces, bulletins, calendars, price list, references, and other such information; must include the entire PI

95
Q

Program where FDA asks health care professionals to assist in recognizing misleading promotional activities and reporting them

A

Bad Ad Program

96
Q

Regulations for broadcast media for advertising

A

Advertise summary of risks in audio and video form as long as there is an “adequate provision” for the consumer to obtain full labeling info through a multifaceted approach from four sources 1) toll free number, 2) internet web address, 3) referral to print advertisement in a concurrently running print publication or available brochures, 4) referral to a health care professional

97
Q

Regulations for print advertising

A

Suggested to list the most serious and common risks associated with the product in consumer user friendly way by modifying approved patient labeling such as PI or MedGuides OR including info contained in highlights section of the PI

98
Q

These ads name the drug AND the condition it treats and are subject to regulations

A

Product claim ads

99
Q

These ads name the drug but NOT uses, they are not subject to regulations

A

Reminder ads

100
Q

These ads are educational in nature and do not mention the name of product, only the name of the company. They generally inform the consumer about the disease, mentioning that a physician can treat a particular condition with medications and urge consumer to see physician. Not subject to regulation

A

Health seeking ads

101
Q

Can the FDA preview Direct to consumer ads?

A

Yes, the FDAAA allows FDA to require a preview. The FDA is limited to providing recommendations to the company and can require change in an ad if the change addresses serious risks associated with the drug’s use.

102
Q

(T/F) FDA will look at the “net impression” that the ad conveys from the perspective of a reasonable consumer

A

True

103
Q

Companies can promote prescription drug for off-label use if:

A
  • Filed an application for approval for the use
  • Submit to the agency, 60 days before dissemination, of a copy of the info to be disseminated and any clinical trial info the company has
  • Include with the disseminated info, a disclose that the use has not been approved, a copy of the official labeling of the product, any other products or treatments that have been approved for use, the funding source for any studies relating to the use, and a bibliography of scientific publications regarding the use
104
Q

Who regulates OTC advertising by manufacturers?

A

the FTC

105
Q

OTC advertising has pre-market requirements?

A

False

106
Q

(T/F) The largest focus of OTC advertising is the accuracy of claims

A

True, advertising claims must have a reasonable and rationale basis
Ex. listerine ads claiming efficacy of mouthwash against common cold (ingredients were not present in sufficient quantity to have therapeutic effect, it was impossible to reach critical areas of the body in significant concentration through normal use of gargling, gargling couldn’t reach tissue cells and thus the viruses, clinical studies were unreliable, the millions of germs killed by mouthwash had no medical significant to cold viruses).

107
Q

Who advertises food and who is in charge of its labeling?

A

FTC advertises food but FDA labels

Federal Law (7 decks)

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