FDA Exam 3 (self-made)

What are the 6 core ethical principles in healthcare?

Honesty, Promise-Keeping, Nonmaleficence, Beneficence, Autonomy, Justice

What does nonmaleficence mean?

"Do no harm."

What is the ethical principle of autonomy?

Respecting a person’s right to make their own decisions.

What is an ethical dilemma?

A situation where ethical principles conflict and a choice must be made.

How are cosmetics defined under the law?

Products applied to the body for beautification or appearance change.

Are cosmetics subject to FDA premarket approval?

No, premarket approval is not required.

What makes a cosmetic misbranded?

False/misleading labeling, improper packaging, or lack of required information.

What makes a cosmetic adulterated?

If it contains harmful substances or is manufactured under unsanitary conditions.

Are GMPs mandatory for cosmetics?

No, they are voluntary.

What does DSHEA (1994) do?

Defines dietary supplements and sets regulatory standards.

What is a dietary supplement?

A product containing vitamins, minerals, herbs, amino acids, or similar substances, taken orally.

Does FDA approve dietary supplements before marketing?

No, FDA does not evaluate them before they are marketed.

What must manufacturers do for new dietary ingredients (NDIs)?

Notify FDA 75 days before marketing.

What claim requires a disclaimer on supplements?

Structure/function claims (e.g., "supports immune health").

What does the required supplement disclaimer say?

"This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

Who regulates supplement advertising?

The Federal Trade Commission (FTC).

What is the purpose of the PPPA?

To prevent child poisoning by requiring child-resistant packaging.

What are the requirements for child-resistant containers?

80% of children cannot open it; 90% of adults can.

Who can request non-child-resistant containers?

Patients (blanket request) and prescribers (for individual prescriptions only).

Can manufacturers market non-child-resistant packages?

Yes, one size per product with labeling stating it's for households without children.

Name one example of a drug exempt from PPPA.

Sublingual nitroglycerin tablets.

What did the Federal Anti-Tampering Act (1982) make illegal?

Tampering with consumer products.

What packaging must OTCs and some cosmetics/devices use?

Tamper-evident packaging.

What happens if a product lacks tamper-evident packaging?

It may be considered adulterated or misbranded.

What must prescription drug advertisements to professionals include under FDA regulations?

A true statement of side effects, contraindications, and effectiveness, presented clearly with appropriate font size and order.

What constitutes a violation of the FDA’s “true statement” requirement in drug ads?

When the ad is false or misleading, lacks fair balance, omits material facts, or provides unequal detail between risks and benefits.

What are the four sources a DTC ad must provide for full labeling information?

1) Print ad/brochure, 2) Toll-free number, 3) Internet webpage, 4) Healthcare provider.

What’s the difference between non-product-specific and product-specific DTC advertising?

Non-product-specific doesn't name the drug or company; product-specific must follow FDA rules and be understandable to consumers.

What is the FDA’s definition of a medical device?

An article used for diagnosis, treatment, or structure/function alteration that doesn’t work through chemical action or require metabolism.

What are examples of Class I medical devices?

Needles, toothbrushes, scissors, stethoscopes.

What distinguishes Class II medical devices from Class I?

Class II requires general and specific performance controls; examples include insulin syringes and thermometers.

What are characteristics of Class III medical devices?

Life-supporting/sustaining, high risk, require premarket approval; examples include pacemakers and heart valves.

What can the FDA do regarding unsafe or misclassified devices?

Recall, repair, refund, replace, seize, enjoin shipment, withdraw approval, or reclassify the device.

What happens to devices introduced after 1976?

They are initially placed in Class III until reviewed and reclassified if appropriate.

What is the basis for FDA's enforcement activities?

Medical and technical evaluations of product safety, effectiveness, and labeling.

What are the three sources of FDA’s enforcement power?

• Laws passed by Congress

• FDA regulations

• Policy guidance documents

What is the main objective of FDA enforcement?

To ensure food, drugs, medical devices, and cosmetics comply with applicable laws and regulations.

What percentage of inspections find substantial compliance?

85–90%

What are the two types of enforcement powers used by the FDA?

• Administrative

• Judicial

Can the FDA use administrative enforcement on its own?

Yes

What are common administrative enforcement tools?

• Inspections

• FDA Form 483

• Warning letters

• Adverse publicity

• Recalls

• Delay/suspension of product approval

• Civil money penalties

• Debarment

• Detention/refusal of imports

• Contract preclusion

What specific powers does FDA have over medical devices?

• Detain devices

• Stop marketing

• Advise users to stop using

• Order recalls

• Order repair, replacement, or refunds

What can the FDA do specifically with biologics?

• Order recalls

• Revoke/suspend licenses

• Retain, destroy, or stop manufacturing of cell/tissue-based products

What are informal administrative actions?

• Meetings to encourage compliance

• Monitoring of corrective action plans

• Voluntary agreements

• Referral to state/local authorities

Who handles FDA enforcement litigation?

The Department of Justice, on recommendation from FDA Chief Counsel

What are judicial enforcement tools?

• Civil seizures

• Injunctions

• Criminal prosecutions

• Court-ordered civil money penalties

• Restitution

• Disgorgement

What is "restitution" in FDA enforcement?

Refunds to customers

What is "disgorgement"?

Surrender of ill-gotten gains

When does FDA skip giving prior notice?

If violations are intentional, gross, flagrant, or a health danger

What are the six factors FDA considers before taking enforcement action?

• Seriousness of the issue

• Number of people affected

• Degree of impact

• Strength of evidence

• Likelihood of success

• Federal resource requirements

(Belmont Report) What is the primary purpose of the Belmont Report?

To outline ethical principles and guidelines for research involving human subjects.

(Belmont Report) What are the three core ethical principles of the Belmont Report?

Respect for Persons, Beneficence, and Justice.

(Belmont Report) What does “Respect for Persons” entail?

Treating individuals as autonomous agents and providing additional protections for those with diminished autonomy.

(Belmont Report) What are key components of informed consent under “Respect for Persons”?

Information, comprehension, and voluntariness.

(Belmont Report) What does “Beneficence” require of researchers?

To maximize benefits and minimize possible harms; to do no harm.

(Belmont Report) What is meant by “Justice” in research ethics?

Fair distribution of the benefits and burdens of research among all groups.

(Belmont Report) What does a proper risk/benefit assessment include?

Identifying risks and benefits to both individuals and society, and minimizing harm.

(Belmont Report) Why is the fair selection of research subjects important?

To avoid exploiting vulnerable populations and to ensure equity in the research process.

(Belmont Report) How does the Belmont Report view the use of vulnerable populations in research?

Their use must be justified by the potential for direct benefit and not merely for convenience.

(Belmont Report) When was the Belmont Report published, and by whom?

In 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

(World Medical Association Declaration of Helsinki)

What is the primary purpose of the Declaration of Helsinki?

To provide ethical principles for medical research involving human participants.

(World Medical Association Declaration of Helsinki)

Who developed the Declaration of Helsinki?

The World Medical Association (WMA)

(World Medical Association Declaration of Helsinki)

When was the Declaration of Helsinki first adopted?

June 1964.

(World Medical Association Declaration of Helsinki)

What is the primary obligation of physicians according to the Declaration?

To prioritize the health, well-being, and rights of patients, including those in research.

(World Medical Association Declaration of Helsinki)

What must all medical research involving human participants be based on?

Sound scientific evidence and a well-documented research protocol.

(World Medical Association Declaration of Helsinki)

What role do research ethics committees play in medical research?

They review, approve, and monitor research protocols to ensure ethical compliance.

(World Medical Association Declaration of Helsinki)

When is it acceptable to use a placebo in research?

When no proven intervention exists or when scientifically justified without adding serious risk to participants.

(World Medical Association Declaration of Helsinki)

What is required for informed consent in research?

Voluntary agreement after being fully informed about the study in plain language.

(World Medical Association Declaration of Helsinki)

What must happen if a participant cannot give informed consent?

Consent must be obtained from a legally authorized representative.

(World Medical Association Declaration of Helsinki)

What must researchers do if risks outweigh potential benefits during a study?

Reassess and potentially modify or halt the research.

(World Medical Association Declaration of Helsinki)

How must vulnerable populations be treated in research?

With special protections and only included if the research is responsive to their needs and cannot be done otherwise.

(World Medical Association Declaration of Helsinki)

What must be provided after a clinical trial if the intervention proves beneficial?

Post-trial access to the intervention, arranged by sponsors or health systems.

(World Medical Association Declaration of Helsinki)

What is required for storing biological materials or identifiable data?

Informed consent and compliance with the Declaration of Taipei.

(World Medical Association Declaration of Helsinki)

Must negative or inconclusive results of a study be published?

Yes, all results must be publicly accessible.

(World Medical Association Declaration of Helsinki)

Can unproven interventions be used outside clinical trials?

Only if necessary to help an individual patient and followed by formal research to evaluate them.

(Nuremberg Code)

What historical event led to the creation of the Nuremberg Code?

The war crimes tribunal at Nuremberg following World War II.

(Nuremberg Code)

What is the primary ethical requirement introduced by the Nuremberg Code?

Voluntary informed consent of the human subject.

(Nuremberg Code)

Why is voluntary informed consent essential?

It protects the individual’s right to control their own body and ensures they understand the nature, risks, and purpose of the experiment.

(Nuremberg Code)

What must be avoided according to the Nuremberg Code?

Unnecessary pain, suffering, and injury to human subjects.

(Nuremberg Code)

What must be true about the results of a medical experiment?

They must be fruitful for the good of society and not achievable by other methods.

(Nuremberg Code)

What is required before conducting experiments on humans?

Prior animal experimentation and understanding of the disease/problem.

(Nuremberg Code)

What should be avoided in experiment design?

All unnecessary physical and mental suffering and injury.

(Nuremberg Code)

When is it unethical to conduct an experiment?

When there is a prior reason to believe it may result in death or disabling injury, unless the researchers are also participants.

(Nuremberg Code)

How should the degree of risk be determined?

It should never exceed the importance of the problem being solved.

(Nuremberg Code)

What must be in place to protect subjects from harm?

Proper preparations and adequate facilities.

(Nuremberg Code)

Who should conduct human experiments?

Only scientifically qualified persons using the highest skill and care.

(Nuremberg Code)

What rights do human subjects have during the experiment?

They can end their participation at any time for physical or mental reasons.

(Nuremberg Code)

What is the responsibility of the lead scientist during the experiment?

To terminate the experiment if continuation poses a risk of injury, disability, or death.

What’s the difference between Belmont Report, World Medical Association (WMA) Declaration of Helsinki, and Nuremberg Code?

• Nuremberg Code - to set ethical standards for cunducting human experimentation

  • developed after Nuremberg Trials of Nazi doctors post-WWII

  • voluntary informed consent

  • benefits must outweigh risks

  • subjects must be free to withdraw

• Declaration of Helsinki - ethical principles for medical research involving human subjects

  • issued by World Medical Association

  • research must be ethically justified

  • informed consent

  • special protections for vulnerable populations

  • physicians must protect research subjects

• Belmont Report - defines basic ethical principles for US human subjects research

  • Issued by US National Commission

  • basic ethical principles:

    • respect for persons (autonomy & informed consent)

    • Benefience (max benefits, minimize harm)

    • Justice (fair distribution of research burdens/benefits)