Pharmacy Benefit Managers and the Federal Trade Commission: A Relationship Gone Sour.

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.

Does Regulating Dietary Supplements as Food in a World of Social Media Influencers Promote Public Safety?

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.

Trends in Cigarette Marketing Expenditures, 1975-2019: An Analysis of Federal Trade Commission Cigarette Reports.

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.

A proposal for shoring up Federal Trade Commission protections for electronic health record-connected consumer apps under 21st Century Cures.

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.

A Comparison between Cigarette Topography from a One-Week Natural Environment Study to FTC/ISO, Health Canada, and Massachusetts Department of Public Health Puff Profile Standards.

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.

The Federal Trade Commission and Consumer Protections for Mobile Health Apps.

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.

Legal aspects of information sharing and communication by poison centers in the United States.

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.

Legal and Ethical Analysis of Advertising for Elective Egg Freezing.

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.

The Federal Trade Commission's mandated Four Loko labeling fails to facilitate accurate estimation of alcohol content by college students.

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.

Who's on third? Regulation of third-party genetic interpretation services.

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.

Expanded FDA regulation of health and wellness apps.

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.

Time for Change: Stepping Up the FDA's Regulation of Dietary Supplements to Promote Consumer Safety and Awareness.

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.

Advocacy, Research, and Anesthesia Practice Models: Key Studies of Safety and Cost-Effectiveness.

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.

A Primer on Social Media Use by Young Plastic Surgeons.

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.

The Dark Data Quandary.

The digital universe remains a black box. Despite attaining high-technology capabilities like artificial intelligence and cognitive computing, "Big Data" analytics have failed to keep pace with surging data production. At the same time, the falling costs of cloud storage and distributed systems have made mass data storage cheaper and more accessible. These effects have produced a chasm between data that is stored and data that can be readily analyzed and understood. Enticed by the promise of extracting future value from rising data stockpiles, organizations now retain massive quantities of data that they cannot presently know or effectively manage. This rising sea of "dark data" now represents the vast majority of the digital universe. Dark data presents a quandary for organizations and the judicial system. For organizations, the inability to know the contents of retained dark data produces invisible risk under a spreading patchwork of digital privacy and data governance laws, most notably in the medical and consumer protection areas. For courts increasingly confronted with Big Data-derived evidence, dark data may shield critical information from judicial view while embedding subjective influences within seemingly objective methods. To avoid obscuring organizational risk and producing erroneous outcomes in the courtroom, decision-makers must achieve a new awareness of dark data's presence and its ability to undermine Big Data's vaunted advantages.

Medical Marketing in the United States, 1997-2016.

IMPORTANCE: Manufacturers, companies, and health care professionals and organizations use an array of promotional activities to sell and increase market share of their products and services. These activities seek to shape public and clinician beliefs about laboratory testing, the benefits and harms of prescription drugs, and some disease definitions. OBJECTIVE: To review the marketing of prescription drugs, disease awareness campaigns, health services, and laboratory tests and the related consequences and regulation in the United States over a 20-year period (1997-2016). EVIDENCE: Analysis (1997-2016) of consumer advertising (Kantar Media data for spending and number of ads); professional marketing (IQVIA Institute for Human Data Science, Open Payments Data [Centers for Medicare & Medicaid Services]); regulations and legal actions of the US Food and Drug Administration (FDA), Federal Trade Commission (FTC), state attorneys general, and US Department of Justice; and searches (1975-2018) of peer-reviewed medical literature (PubMed), business journals (Business Source Ultimate), and news media (Lexis Nexis) for articles about expenditures, content, and consequences and regulation of consumer and professional medical marketing. Spending is reported in 2016 dollars. FINDINGS: From 1997 through 2016, spending on medical marketing of drugs, disease awareness campaigns, health services, and laboratory testing increased from $17.7 to $29.9 billion. The most rapid increase was in direct-to-consumer (DTC) advertising, which increased from $2.1 billion (11.9%) of total spending in 1997 to $9.6 billion (32.0%) of total spending in 2016. DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies. Pharmaceutical companies increased DTC marketing about diseases treated by their drugs with increases in disease awareness campaigns from 44 to 401 and in spending from $177 million to $430 million. DTC advertising for health services increased from $542 million to $2.9 billion, with the largest spending increases by hospitals, dental centers, cancer centers, mental health and addiction clinics, and medical services (eg, home health). DTC spending on advertising for laboratory tests (such as genetic testing) increased from $75.4 million to $82.6 million, although the number of ads increased more substantially (from 14 100 to 255 300), reflecting an increase in less expensive electronic media advertising. Marketing to health care professionals by pharmaceutical companies accounted for most promotional spending and increased from $15.6 billion to $20.3 billion, including $5.6 billion for prescriber detailing, $13.5 billion for free samples, $979 million for direct physician payments (eg, speaking fees, meals) related to specific drugs, and $59 million for disease education. Manufacturers of FDA-approved laboratory tests paid $12.9 million to professionals in 2016. From 1997 through 2016, the number of consumer and professional drug promotional materials that companies submitted for FDA review increased from 34 182 to 97 252, while FDA violation letters for misleading drug marketing decreased from 156 to 11. Since 1997, 103 financial settlements between drug companies and federal and state governments resulted in more than $11 billion in fines for off-label or deceptive marketing practices. The FTC has acted against misleading marketing by a single for-profit cancer center. CONCLUSIONS AND RELEVANCE: Medical marketing increased substantially from 1997 through 2016, especially DTC advertising for prescription drugs and health services. Pharmaceutical marketing to health professionals accounted for most spending and remains high even with new policies to limit industry influence. Despite the increase in marketing over 20 years, regulatory oversight remains limited.