دورية أكاديمية
Federal Trade Commission Actions on Prescription Drugs, 2000-2022.
| العنوان: | Federal Trade Commission Actions on Prescription Drugs, 2000-2022. |
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| المؤلفون: | Daval CJR; Program 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., Egilman AC; Program 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., Sarpatwari A; Program 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., Kesselheim AS; Program 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. |
| المصدر: | JAMA [JAMA] 2024 Jun 18; Vol. 331 (23), pp. 2029-2036. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago : American Medical Association, 1960- |
| مواضيع طبية MeSH: | Drug Industry*/legislation & jurisprudence , Legislation, Drug* , Prescription Drugs*/economics , United States Federal Trade Commission*, Humans ; Economic Competition/legislation & jurisprudence ; Patents as Topic/legislation & jurisprudence ; United States |
| مستخلص: | Importance: The Federal Trade Commission's (FTC) oversight role in the pharmaceutical market is critical to the health of patients and the health care system. This study characterized the FTC's policy on the pharmaceutical market in recent decades, identifying the types of actions it has favored, barriers it has faced, and authorities that remain untested. Objective: To review FTC legal actions in the pharmaceutical market from 2000-2022. Evidence Review: Legal actions were determined through manual review of search results from the FTC's online Legal Library as well as a 2023 FTC report on pharmaceutical actions. The alleged misconduct, type of legal action taken, timing, and outcome were collected from press releases, complaints, orders, and other legal documents. Findings: From 2000-2022, the FTC challenged 62 mergers, brought 22 enforcement actions against allegedly unlawful business practices, and made 1 rule related to pharmaceuticals. Alleged misconduct in enforcement actions involved anticompetitive settlements in patent litigation (n = 11), unilateral actions by brand manufacturers to delay generic competition (n = 6), noncompete agreements (n = 4), and monopolization (n = 3), with 10 outcomes involving monetary payment, totaling $1.6 billion. Of the 62 mergers the FTC challenged, 61 were allowed to continue, 58 after divesting certain drugs to third-party competitors. The FTC's reliance on drug divestitures decreased from 18 drugs per year from 2000-2017 to 4.3 per year from 2017-2023. Conclusions and Relevance: The FTC brought about 1 enforcement action and 3 merger actions per year against pharmaceutical manufacturers from 2000-2022, pursuing a small fraction of the estimated misconduct and consolidation in the pharmaceutical marketplace. Although the FTC faces substantial legal and practical limitations, important tools remain untested, including a rule defining "unfair methods of competition," that may allow it to more effectively prevent repetitive patterns of anticompetitive behavior. |
| التعليقات: | Comment in: JAMA. 2024 Jun 18;331(23):1995-1996. doi: 10.1001/jama.2024.1509. (PMID: 38767914) |
| المشرفين على المادة: | 0 (Prescription Drugs) |
| تواريخ الأحداث: | Date Created: 20240520 Date Completed: 20240618 Latest Revision: 20240708 |
| رمز التحديث: | 20240708 |
| DOI: | 10.1001/jama.2024.5737 |
| PMID: | 38767878 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1538-3598 |
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| DOI: | 10.1001/jama.2024.5737 |