処方薬に関する連邦貿易委員会の行動 (2000年~2022年)

C Joseph Ross Daval¹, Alexander C Egilman¹, Ameet Sarpatwari¹

¹Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

JAMA

|May 20, 2024

まとめ

連邦貿易委員会 (FTC) は2000年から2022年にかけての医薬品市場の不正行為に対して限られた措置をとった. テストされていない当局は,反競争的行動を扱う新しい方法を提案するかもしれません.

科学分野:

健康政策
独占禁止法
医薬品経済学

背景:

連邦貿易委員会 (FTC) は,医薬品市場を監督する上で重要な役割を果たしています.
FTCの過去の行動を理解することは,患者の健康と医療システムへの影響を評価するために不可欠です.

研究の目的:

連邦貿易委員会 (FTC) の近年における医薬品市場政策を記述する.
薬剤業界におけるFTCの優遇された行動,直面した障壁,未検証の権限を特定する.

主な方法:

FTCのオンラインの法律ライブラリと2023年製薬行動に関するFTC報告書のマニュアルレビュー
2000年から2022年にかけての法的文書 (プレスリリース,苦情,命令) を分析し,不正行為,法的措置,タイミング,結果に関するデータを収集する.

主要な成果:

FTCは2000年から2022年の間に22の強制措置を講じ,62の合併に異議を唱え,特許和解,ジェネリック入国遅延,非競争協定,独占などの問題に対処した.
10つの結果で合計16億ドルの罰金を科しました.
合併の課題は主に麻薬の売却につながり,近年では減少傾向にある.

結論:

FTCの行動は,医薬品市場における誤った行動と統合の小さな部分を表しています.
法律と実務上の制限がFTCの有効性を妨げています.
"不公正な競争方法"のルールのような未検証の権威は,反復的な反競争行動を扱う可能性を持っています.

さらに関連する動画

05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

9.6K

09:24

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

Published on: August 22, 2017

8.4K

関連する概念動画

01:02

Prescription, Nonprescription and Orphan Drugs

721

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...

721

01:25

Drug Regulation

1.4K

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...

1.4K

01:03

Drug Control Governance: Regulatory Bodies and Their Impact

156

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...

156

01:25

Drug Classes and Categories

2.0K

Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...

2.0K

01:26

Drug Administration and Therapy Phases: Overview

448

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...

448

01:16

Clinical Trials

6.7K

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...