Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 1.370
Filtrar
1.
JAMA ; 331(23): 2029-2036, 2024 06 18.
Artigo em Inglês | MEDLINE | ID: mdl-38767878

RESUMO

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.


Assuntos
Indústria Farmacêutica , Legislação de Medicamentos , Medicamentos sob Prescrição , United States Federal Trade Commission , Humanos , Indústria Farmacêutica/legislação & jurisprudência , Competição Econômica/legislação & jurisprudência , Patentes como Assunto/legislação & jurisprudência , Medicamentos sob Prescrição/economia , Estados Unidos
4.
JAMA ; 329(5): 367-368, 2023 02 07.
Artigo em Inglês | MEDLINE | ID: mdl-36622666

RESUMO

This Viewpoint provides a brief history of pharmacy benefit managers (PBMs), describes the ways in which PBMs have acquired influence in the prescription drug distribution system, and suggests possible scenarios surrounding the June 2022 decision by the Federal Trade Commission to launch an investigation into PBM business practices.


Assuntos
Seguro de Serviços Farmacêuticos , Relações Interprofissionais , Farmácia , United States Federal Trade Commission , Estados Unidos
5.
AMA J Ethics ; 24(5): E396-401, 2022 05 01.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-35575571

RESUMO

Social media influencers promote a wide variety of products, including dietary supplements. Dietary supplements are regulated as foods, not drugs, by the US Food and Drug Administration and the Federal Trade Commission. This article details weaknesses in administrative and common law regulatory approaches to addressing some influencers' negligent misrepresentation claims about dietary supplements.


Assuntos
Mídias Sociais , Suplementos Nutricionais/efeitos adversos , Humanos , Estados Unidos , United States Federal Trade Commission , United States Food and Drug Administration
6.
Nicotine Tob Res ; 24(6): 919-923, 2022 04 28.
Artigo em Inglês | MEDLINE | ID: mdl-34988582

RESUMO

INTRODUCTION: With tightened regulations on cigarette marketing and decreased smoking, the major tobacco companies quickly shifted their marketing expenditures in recent decades to maintain profits. We investigated cigarette marketing expenditures in the United States from 1975 through 2019 to examine the trends in cigarette marketing expenditures over the past 45 years. AIMS AND METHODS: Cigarette marketing expenditure data were obtained from the Federal Trade Commission (FTC) cigarette reports, 1975-2019. Based on individual expenditure categories included in the FTC reports, we created seven aggregate categories for marketing expenditures: Retail; Print; Out of home; Free tobacco products and gifts; Sports, public entertainment, and sponsorships; Telephone and digital; and Other. Dollar amounts and percentages by category were examined to assess trends in marketing expenditures. RESULTS: Cigarette marketing expenditures increased since 1975 and peaked in 2003 at $21.1 billion (adjusted dollars); afterward, they declined dramatically until 2010 and remained stable at around $9 billion through 2019. While all other expenditures decreased, retail expenditures increased, comprising more than 50% of expenditures in 1988 and reaching about 98% in 2019. In the retail category, tobacco companies spent the most on promotional allowances, coupons, and retail-value-added bonuses between 1988 and 2003, after which price discounts dominated retail spending. CONCLUSIONS: Overall, cigarette marketing expenditures peaked in 2003 and retail first became the leading category in 1988. Tobacco companies adapted their marketing strategies in retail and allocated most of their retail spending on price discounts since 2003 to lower cigarette prices. IMPLICATIONS: The major US tobacco companies directed the bulk of their vast spending on the retail environment since 1988. Moreover, they have dramatically shifted their marketing strategies within the retail category from cigarette advertising before 2003 to customer-directed price discounts since then. This shift may imply a change in focus from recruiting new smokers to retaining current smokers, in response to tax increases and government regulations. Accordingly, restrictions on price-related promotions in retail and nontax strategies should be implemented to counter tobacco companies' marketing efforts in retail.


Assuntos
Indústria do Tabaco , Produtos do Tabaco , Publicidade , Comércio , Gastos em Saúde , Humanos , Marketing , Nicotiana , Estados Unidos , United States Federal Trade Commission
8.
J Am Med Inform Assoc ; 28(3): 640-645, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33306804

RESUMO

Under the 21st Century Cures Act and the Office of the National Coordinator for Health Information Technology (ONC) rule implementing its interoperability provisions, a patient's rights to easily request and obtain digital access to portions of their medical records are now supported by both technology and policy. Data, once directed by a patient to leave a Health Insurance Portability and Accountability Act-covered health entity and enter a consumer app, will usually fall under Federal Trade Commission oversight. Because the statutory authority of the ONC does not extend to health data protection, there is not yet regulation to specifically address privacy protections for consumer apps. A technologically feasible workflow that could be widely adopted and permissible under ONC's rule, involves using the SMART on FHIR OAuth authorization routine to present standardized information about app behavior. This approach would not bias the patient in a way that triggers penalties under information blocking provisions of the rule.


Assuntos
Confidencialidade/legislação & jurisprudência , Registros Eletrônicos de Saúde/legislação & jurisprudência , Software/legislação & jurisprudência , United States Federal Trade Commission , Qualidade de Produtos para o Consumidor , Humanos , Razão de Chances , Privacidade/legislação & jurisprudência , Estados Unidos
9.
Artigo em Inglês | MEDLINE | ID: mdl-32429116

RESUMO

Standardized topography protocols for testing cigarette emissions include the Federal Trade Commission/International Standard Organization (FTC/ISO), the Massachusetts Department of Health (MDPH), and Health Canada (HC). Data are lacking for how well these protocols represent actual use behavior. This study aims to compare puff protocol standards to actual use topography measured in natural environments across a range of cigarette brands. Current smokers between 18 and 65 years of age were recruited. Each participant was provided with a wPUM™ cigarette topography monitor and instructed to use the monitor with their usual brand cigarette ad libitum in their natural environment for one week. Monitors were tested for repeatability, and data were checked for quality and analyzed with the TAP™ topography analysis program. Data from n = 26 participants were analyzed. Puff flow rates ranged from 17.2 to 110.6 mL/s, with a mean (STD) of 40.4 (21.7) mL/s; durations from 0.7 to 3.1 s, with a mean (STD) of 1.5 ± 0.5 s; and volumes from 21.4 to 159.2 mL, with a mean (STD) of 54.9 (29.8) mL. Current topography standards were found to be insufficient to represent smoking across the wide range of real behaviors. These data suggest updated standards are needed such that emissions tests will provide meaningful risk assessments.


Assuntos
Meio Ambiente , Saúde Pública , Fumar , Produtos do Tabaco , Adolescente , Adulto , Idoso , Canadá , Humanos , Massachusetts , Pessoa de Meia-Idade , Fumar/psicologia , Estados Unidos , United States Federal Trade Commission , Adulto Jovem
11.
J Law Med Ethics ; 48(1_suppl): 103-114, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32342745

RESUMO

The Federal Trade Commission (FTC) has an important role to play in the governmental oversight of mobile health apps, ensuring consumer protections from unfair and deceptive trade practices and curtailing anti-competitive methods. The FTC's consumer protection structure and authority is outlined before reviewing the recent FTC enforcement activities taken on behalf of consumers and against developers of mhealth apps. The article concludes with identification of some challenges for the FTC and modest recommendations for strengthening the consumer protections it provides.


Assuntos
Aplicativos Móveis/legislação & jurisprudência , Telemedicina/legislação & jurisprudência , United States Federal Trade Commission , Comércio , Enganação , Competição Econômica , Humanos , Aplicativos Móveis/economia , Telemedicina/economia , Estados Unidos
12.
Clin Toxicol (Phila) ; 58(7): 669-675, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-31935123

RESUMO

To keep pace with changing technology and to provide better treatment to the public, U.S. poison control centers have increasingly implemented new ways of communicating with healthcare providers and with patients, including electronic transfer of patient information. Innovation in communication and information sharing raises concerns over patient privacy and compliance with applicable laws. This narrative review analyzes both typical activities and emerging innovations of PCCs in relation to U.S. law and regulation regarding privacy, specifically the Health Insurance Portability and Accountability Act, the Substance Abuse and Mental Health Treatment Act, and the Federal Trade Commission Act. PCCs that are "covered entities" under HIPAA may exchange patient health information with other providers by telephone for purposes of treatment, and certainly during the emergency management of poisonings. SAMHSA regulations, however, limit information that can be shared outside of emergencies without patient consent. The FTC Act prohibits unfair or deceptive trade practices which may in some circumstances involve privacy violations. Text message exchanges between PCCs and patients present particularly difficult privacy challenges under these laws.


Assuntos
Confidencialidade/legislação & jurisprudência , Disseminação de Informação/legislação & jurisprudência , Centros de Controle de Intoxicações/legislação & jurisprudência , Comunicação , Health Insurance Portability and Accountability Act , Humanos , Centros de Controle de Intoxicações/estatística & dados numéricos , Envio de Mensagens de Texto/legislação & jurisprudência , Estados Unidos , United States Federal Trade Commission
13.
J Law Med Ethics ; 48(4): 748-764, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33404329

RESUMO

This paper reviews common advertising claims by egg freezing companies and evaluates the medical evidence behind those claims. It then surveys legal standards for truth in advertising, including FTC and FDA regulations and the First Amendment right to free speech. Professional standards for medical advertising, such as guidelines published by the American Society for Reproductive Medicine (ASRM), the American College of Obstetricians and Gynecologists (ACOG), and the American Medical Association (AMA), are also summarized. A number of claims, many of which relate to the targeting of younger women for eOC, are found to breach legal and ethical standards for truth in advertising. The ethical implications of misleading advertising claims are also discussed, and the central narrative woven by OC ads - that egg freezing is empowering to women - is examined. The paper concludes that a more balanced approach to the risks and benefits of OC is necessary to truly respect women's autonomy. Moreover, justice requires us to look beyond a medical procedure accessible only to a minority of women in order to address inequities in the workplace.


Assuntos
Publicidade/ética , Publicidade/legislação & jurisprudência , Criopreservação , Óvulo , Publicidade/normas , Feminino , Regulamentação Governamental , Guias como Assunto , Humanos , Sociedades Médicas , Estados Unidos , United States Federal Trade Commission , United States Food and Drug Administration
14.
Genet Med ; 22(1): 4-11, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31402353

RESUMO

In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services' Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.


Assuntos
Serviços em Genética/organização & administração , Testes Genéticos/legislação & jurisprudência , Centers for Medicare and Medicaid Services, U.S. , Triagem e Testes Direto ao Consumidor , Serviços em Genética/legislação & jurisprudência , Humanos , Medição de Risco , Estados Unidos , United States Dept. of Health and Human Services , United States Federal Trade Commission , United States Food and Drug Administration
15.
Bioethics ; 34(3): 235-241, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31633831

RESUMO

This paper argues that the Food and Drug Administration's (FDA) policy for health and wellness apps is ethically problematic. Currently, the FDA does not regulate health and wellness apps that are not intended for medical use. As a result of this hands-off policy, preventing harm to consumers is left primarily to developers and app marketplaces. We argue that the FDA's duties to prevent harm and maintain accountability to the American public require that they play a much stronger role. We also discuss concerns about efficiency and fostering innovation, and argue that while they should help shape FDA regulation of health and wellness apps, they do not justify complete absence of FDA involvement.


Assuntos
Qualidade de Produtos para o Consumidor/legislação & jurisprudência , Estilo de Vida Saudável , Aplicativos Móveis/legislação & jurisprudência , Regulamentação Governamental , Humanos , Política Organizacional , Estados Unidos , United States Federal Trade Commission/legislação & jurisprudência , United States Food and Drug Administration/legislação & jurisprudência
16.
Am J Drug Alcohol Abuse ; 46(4): 430-437, 2020 07 03.
Artigo em Inglês | MEDLINE | ID: mdl-31592678

RESUMO

BACKGROUND: Four Loko, the leading supersized alcopop brand, is a pre-mixed alcoholic beverage containing up to 5.5 standard alcoholic drinks in a can. In 2013, the Federal Trade Commission (FTC) mandated the addition to Four Loko cans of a label indicating its alcohol content in standard drinks, presented as "alcohol per serving" and "servings per container." OBJECTIVE: The current study investigated whether college students accurately estimate the alcohol content in cans of Four Loko bearing the FTC mandated labels. METHOD: Undergraduate student drinkers (n = 833; 51.6% women) in three states (Florida, Montana, and Virginia) were provided an empty Watermelon Four Loko can and asked to determine the number of standard drinks it contained, using 12-ounce regular beer (Budweiser) equivalents. In Florida and Virginia, Watermelon Four Loko contains 4.70 standard alcoholic drinks; in Montana, it contains 3.13. RESULTS: More than 60% of Florida students and more than 70% of Virginia students underestimated Four Loko's alcohol content by one or more standard drinks, compared to 45% of Montana students. Multivariable logistic regression analysis found the following variables were associated with greater odds of underestimating Four Loko's alcohol content by one or more standard alcoholic drinks: being female (AOR = 2.2), having never seen nor heard of Four Loko (AOR = 1.9), and residing in Florida (AOR = 1.7) or Virginia (AOR = 2.8) versus Montana. CONCLUSIONS: Students were far less likely to underestimate alcohol content for 8% alcohol-by-volume (abv) cans compared to those with higher alcohol concentrations. Thus, policies restricting supersized alcopops' abv may help consumers better estimate their alcohol content.


Assuntos
Bebidas Alcoólicas/estatística & dados numéricos , Rotulagem de Produtos/estatística & dados numéricos , Estudantes/estatística & dados numéricos , Adolescente , Adulto , Consumo de Bebidas Alcoólicas , Etanol , Feminino , Florida , Humanos , Masculino , Montana , Estados Unidos , United States Federal Trade Commission , Universidades , Virginia , Adulto Jovem
17.
J Law Health ; 33(1): 47-78, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31841617

RESUMO

People are often looking for that quick fix when it comes to their health. With dietary supplements so readily available on the market, the public assume that they have been through rigorous testing. Dietary supplements are not tested as much as consumers believe. The Food and Drug Administration (FDA) does not initiate the same type of testing and analysis for supplements as it does for food, drink and medication. Given that people are now choosing supplemental meal replacements and the like, as opposed to whole foods, regulations drastically need to be stepped up in an effort to emphasise public safety. An authoritative body needs to stop manufacturers from taking advantage of an already vulnerable marketplace. I suggest a new form of regulation that takes the pressure away from the FDA and into the hands of someone who wholly focuses on the supplement market. Dietary supplements have revolutionised the "health" world; however, the only way that the market can keep growing is through enacting more stringent rules and regulations--at the same time allowing consumers to maintain their autonomy and freedom when purchasing.


Assuntos
Qualidade de Produtos para o Consumidor/legislação & jurisprudência , Suplementos Nutricionais/economia , Suplementos Nutricionais/normas , Regulamentação Governamental , Marketing/legislação & jurisprudência , Rotulagem de Produtos/legislação & jurisprudência , Rotulagem de Produtos/normas , Suplementos Nutricionais/efeitos adversos , Legislação sobre Alimentos/tendências , Estados Unidos , United States Federal Trade Commission , United States Food and Drug Administration
18.
Policy Polit Nurs Pract ; 20(4): 193-204, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31510877

RESUMO

The practice of anesthesia includes multiple competing practice models, including services delivered by anesthesiologists, independent practice by certified registered nurse anesthetists (CRNAs), and team-based approaches incorporating anesthesiologist supervision or direction of CRNAs. Despite data demonstrating very low risk of death and complications associated with anesthesia, debate among professional societies and policymakers persists over the superiority or equivalence among these models. The American Society of Anesthesiologists uses published findings as evidence for claims that anesthesia is safer when anesthesiologists lead in providing care. The American Association of Nurse Anesthetists cites its own research on safety and cost-efficiency outcomes to defend against these claims. We review and critique studies of the safety outcomes and cost-effectiveness of anesthesia delivery that have been cited in the Federal Trade Commission comment letters related to competition in health care, where each profession has laid out their case for how they ought to be recognized in the market for anesthesia services. The Federal Trade Commission has a role in protecting consumers from anticompetitive conduct that has the potential to impact quality and cost in health care. Thus, it is important to evaluate the evidence used to make claims about these topics. We argue that while research in this area is imperfect, the strong safety record of anesthesia in general and CRNAs in particular suggest that politics and professional interests are the main drivers of supervision policy in anesthesia delivery.


Assuntos
Anestesiologistas/economia , Anestesiologistas/normas , Atenção à Saúde/economia , Atenção à Saúde/normas , Enfermeiros Anestesistas/economia , Enfermeiros Anestesistas/normas , Âmbito da Prática , Anestesia/história , Anestesia/mortalidade , Análise Custo-Benefício , História do Século XIX , História do Século XX , História do Século XXI , Humanos , Segurança do Paciente , Política , Sociedades Médicas , Sociedades de Enfermagem , Estados Unidos , United States Federal Trade Commission
20.
Plast Reconstr Surg ; 143(5): 1533-1539, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31033838

RESUMO

Similar to the outcry over the ethics of website marketing by physicians in the 1990s, the resistance to plastic surgeons' use of social media has been loud and vehement. Many physicians, although receptive to website marketing, view social media as too radical or unprofessional. Despite the controversy, the value of social media as a communication tool for interacting with and educating patients is supported by studies showing that 65 percent of Americans and 90 percent of young adults use social media. Many plastic surgeons have been early adopters, as reflected by the articles written to help board-certified plastic surgeons use social media in academic medicine and for their practice. However, there is little guidance for young plastic surgeons who wish to use social media for professional purposes. In this study, the authors discuss the ethics and current literature on social media use by young plastic surgeons and make recommendations for how to use social media during training and after residency graduation.


Assuntos
Marketing de Serviços de Saúde/ética , Mídias Sociais/estatística & dados numéricos , Cirurgiões/ética , Cirurgia Plástica/ética , Humanos , Marketing de Serviços de Saúde/legislação & jurisprudência , Marketing de Serviços de Saúde/normas , Marketing de Serviços de Saúde/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Mídias Sociais/ética , Sociedades Médicas/legislação & jurisprudência , Sociedades Médicas/normas , Cirurgiões/estatística & dados numéricos , Cirurgia Plástica/legislação & jurisprudência , Cirurgia Plástica/normas , Cirurgia Plástica/estatística & dados numéricos , Estados Unidos , United States Federal Trade Commission/legislação & jurisprudência
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...