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Related Concept Videos

Drug Regulation01:25

Drug Regulation

3.0K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

97
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

343
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
343
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

369
Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Dose-Response Relationship: Potency and Efficacy01:22

Dose-Response Relationship: Potency and Efficacy

6.8K
The potency of a drug is the measure of its ability to produce a biological response and can be compared by looking at the half-maximum effective concentration or EC50 values of different drugs. A lower EC50 value indicates higher potency of the drug. In the dose–response curve of two antihypertensive drugs, candesartan and irbesartan, a significant difference is observed in their EC50 values. A lower EC50 value for candesartan indicates that it is more potent than irbesartan, as it...
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Related Experiment Video

Updated: May 4, 2026

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation
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Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

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Drug approval and drug effectiveness.

Glen I Spielmans1, Irving Kirsch

  • 1Department of Psychology, Metropolitan State University, Saint Paul, Minnesota 55108.

Annual Review of Clinical Psychology
|December 17, 2013
PubMed
Summary

The US Food and Drug Administration (FDA) and scientific literature may present a skewed view of psychiatric drug effectiveness and safety. This analysis reveals minimal efficacy requirements and understated harms, impacting evidence-based treatment.

Area of Science:

  • Pharmacology and Psychiatry
  • Regulatory Science
  • Clinical Trial Analysis

Background:

  • Evidence-based psychiatric treatment relies on robust efficacy and safety data.
  • The US Food and Drug Administration (FDA) and scientific publications are key sources for this data.
  • Existing reviews suggest potential limitations in how this data is assessed and presented.

Purpose of the Study:

  • To critically examine the FDA's review process for psychiatric drug clinical trials.
  • To analyze the presentation of psychiatric drug efficacy and safety in the published scientific literature.
  • To identify areas for improvement in data accessibility and regulatory review.

Main Methods:

  • Review of FDA approval processes and legal guidelines for psychiatric medications.

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  • Analysis of FDA reliance on primary vs. secondary outcomes and negative study findings.
  • Examination of how efficacy and harms are reported in the scientific literature.

    • Main Results:

    • Evidence suggests the FDA may require only minimal efficacy for psychiatric drug approval.
    • The FDA has sometimes prioritized secondary outcomes and downplayed negative study results.
    • Published literature frequently overstates treatment efficacy and understates treatment-related harms.

    Conclusions:

    • The current FDA review process and scientific literature may not fully represent psychiatric drug benefits and risks.
    • Improvements are needed in public access to raw safety and efficacy data.
    • Enhancements to the FDA's review methodology could strengthen evidence-based psychiatric care.