Generic Drugs and the Struggle to Compete: The Role of Skinny Labels.

PURPOSE: The generic drug industry currently faces multiple, serious issues that threaten the US drug supply. So-called "skinny labels" are one of the few tools authorized by Congress to expedite entry into the market by generic competitors when the first patent for a brand's drug compound (only) expires. This article reviews the law on this expedited marketing pathway for generic competitors, as well as limitations on its use. METHODS: We examined the literature on patent protection of brand drugs, including the timelines for production of generic competitors. We also examined the law concerning skinny labels, including a recent decision of the US Federal Circuit Court that clearly articulates the guidelines concerning entry into the generic market, including labeling, marketing, and promotion. FINDINGS: Skinny labels that follow the regulations set forth in the Hatch-Waxman Act, including the necessary carve-out procedure for "methods of use" still protected by 1 or more active patents, do not infringe a brand drug's label. Furthermore, the skinny label does not induce or contribute to infringement merely because its label contains US Food and Drug Administration-required safety profile data-even when the data cross-reference superiority studies on still-patent protected methods of use elsewhere in the label. IMPLICATIONS: Generic drugs have become essential to the broad, general availability of clinical therapeutic agents. The Hatch-Waxman Act was intended to facilitate entry of generic competitors into the marketplace, and the skinny label is an important tool to accomplish that end. As long as the generic manufacturer follows the essential skinny-label rules, specifically including marketing the compound without promoting or advertising those methods of use still protected by ongoing patents, the law will not find induced or contributory infringement.

Attitudes on Equal Health Care Access versus Efficient Clinical Decisions across a Not-for-Profit Health Care System.

BACKGROUND: Professional roles within a hospital system may influence attitudes behind clinical decisions. OBJECTIVE: To determine participants' preferences about clinical decisions that either value equal health care access or efficiency. DESIGN: Deidentified survey asking participants to choose between offering a low-cost screening test to a whole population ("equal access") or a more sensitive, expensive test that could be given to only half of the population but resulting in 10% more avoided deaths ("efficient"). Data collection took place from August 18, 2021, to January 24, 2022. Study 1644 was determined to be exempt by Tufts Health Sciences Institutional Review Board (IRB). SETTING: Tufts Medicine Healthcare System. PARTICIPANTS: Approximately 15,000 hospital employees received an e-mail from the Tufts Medicine Senior Vice President of Academic Integration. MEASUREMENTS: Analysis of survey responses with chi-square and 1-sample t tests to determine the proportion who chose each option. Logistic regression models fit to examine relationships between professional role and test choice. RESULTS: A total of 1,346 participants completed the survey (∼9.0% response rate). Overall, approximately equal percentages of respondents chose the "equal access" (48%) and "efficient" option (52%). However, gender, professional role (categorical), and clinical role (dichotomous) were significantly associated with test choice. For example, among those in nonclinical roles, women were more likely than men to choose equal health care access. In multivariable analyses, having clinical roles was significantly associated with 1.73 times the likelihood of choosing equal access (95% confidence interval = 1.33-2.25). LIMITATIONS: Generalizability concerns and survey question wording limit the study results. CONCLUSION: Clinicians were more likely than nonclinicians to choose the equal health care access option, and health care administrators were more likely to choose efficiency. These differing attitudes can affect patient care and health care quality. HIGHLIGHTS: Divergent preferences of valuing equal health care access and efficiency may be in conflict during clinical decision making.In this cross-sectional study that included 1,346 participants, approximately equal percentages of respondents chose the "equal access" (48%) and "efficient" option (52%), a nonsignificant difference. However, gender, professional role (categorical), and clinical role (dichotomous) were significantly associated with test choiceSince clinicians were more likely than nonclinicians to choose the equal health care access option and health care administrators were more likely to choose efficiency, these differing attitudes can affect patient care and health care quality.

Amgen v. Sanofi: The U.S. Supreme Court Reviews Patent Enablement.

On June 18, 2023, the U.S. Supreme Court in the matter of Amgen, Inc. et al. v. Sanofi, et al.1 unanimously upheld the 2021 decision of the U.S. Court of Appeals for the Federal Circuit,2 striking down as overbroad Amgen's patent claim to an entire functional genus of monoclonal antibodies. Amgen's patent claims were not limited to antibody structure or antibody amino acid sequences. This is significant because Amgen's patent claims did have amino acid sequences, but they were directed to the epitope.

The US Supreme Court and Affirmative Action: The Negative Impact on the Physician Workforce.

PURPOSE: Maintaining admissions of underrepresented students to medical schools is essential to securing a diverse health care workforce. Empirical evidence indicates that minority patients may prefer practitioners of their own race. The recent US Supreme Court decision concerning affirmative action makes this goal more difficult, but medical schools can still work within the language of the law to redouble their efforts to seat a diverse class of medical students. METHODS: We examined the literature correlating the availability of minority physicians and the health outcomes of the patients they serve. We also examined the literature on race-conscious policies of medical schools intended to address the shortage of minority physicians considering the benefits achieved through a diverse field of health care workers. We also examined the law and the recent US Supreme Court opinion, including the application of equal protection principles, to suggest strategies to seat a diverse class of students within the scope of the law. FINDINGS: Institutions have maintained the status quo of disparate distributions of professions by race through structural biases that also limit access to medical schools. The new US Supreme Court decision is expected to exacerbate this disparity unless medical schools engage in admissions protocols that actively solicit the character and unique abilities that each of the applicants can offer to contribute to the medical school and the health care profession. IMPLICATIONS: The new US Supreme Court mandate is likely to create challenges for medical schools in their efforts to recruit and seat minority applicants. The mandate provides little discussion, suggesting a lack of understanding of the downstream public health consequences to patients if medical school applicants are denied the benefits of race-conscious admissions policies. Nevertheless, the language of the US Supreme Court's opinion may provide a viable path forward, at least with respect to medical schools where the need for a diverse pool of health care practitioners is particularly compelling.

The Alendronate Conundrum: Balancing the Competing Influences for Truly Informed Consent About Drug Safety in an Era of Rapid Change.

This commentary highlights critical decision points regarding the responsibilities of the key stakeholders-pharmaceutical companies, the US Food and Drug Administration, clinicians, and patients-regarding the communication of the risk of a medication. It addresses responsibility for remaining current about emerging drug reactions that often cannot be appreciated during the initial approval period of new drugs and biologics. Further complicating the issue are the medical systems that limit a clinician's time and bandwidth to keep abreast of emerging adverse reactions and to engage in an informed consent process with a lay patient who often has a limited understanding of medical terms and quantitative methods that can provide context for understanding rare complications and adverse drug reactions. Nevertheless, the risk of not finding an amenable way forward for all stakeholders is a descent into the unending crippling malpractice settlements that will only inexorably raise the costs of health care and encourage the exodus of clinicians from the profession.

Reining in Costs of Kidney Dialysis: US Supreme Court Offers Hope to End Predatory Pricing.

PURPOSE: Two for-profit dialysis providers control >70% of the US kidney dialysis market. They use their excessive market power to force private insurers to pay nearly 4 times the Medicare rate, earning exorbitant profits for themselves at the expense of the health care system. Both the legislative and judicial systems have been called on to address this inequity, so far without success. METHODS: We examined the history of this issue as set forth in official Centers for Medicare & Medicaid Services, US Department of Health and Human Services, Federal Trade Commission, and other regulatory documents as well as court filings and opinions. We analyzed the legislative efforts to address the problem and the judicial response. FINDINGS: We found that most efforts, to date, have failed. However, a 2022 US Supreme Court decision helps illuminate a path forward, in large part by defining the limits of judicial intervention. IMPLICATIONS: We identify a path forward that would separate the monopolistic players using a multipronged effort involving US Department of Justice, Federal Trade Commission, Office of Inspector General, and states attorneys general. We also caution that, based on our research, the providers could challenge further efforts by deciding to withdraw services in certain areas or refuse to do business with certain insurers, resulting in patients having difficulty accessing dialysis.

Four Examples of Potential Competing Interests Affecting How Clinicians Read and Use Research: Financial, Academic, Idealistic, and Personal.

The integrity of published scientific literature relies on transparency. There are processes in place to promote transparency and enhance the trustworthiness of study results. Journals, including the Journal of Orthopaedic & Sports Physical Therapy (JOSPT), require full disclosure of competing interests when authors submit manuscripts for publication. A competing interest is "a financial or intellectual relationship that may impact an individual's ability to approach a scientific question with an open mind." The purpose of this editorial is to discuss the types of competing interests that may influence the work of authors. J Orthop Sports Phys Ther 2020;50(3):116-117. doi:10.2519/jospt.2020.0103.

In ... and out: open access publishing in scientific journals.

Open access (OA) journals are a growing phenomenon largely of the past decade wherein readers can access the content of scientific journals without paying for a subscription. The costs are borne by authors (or their institutions) who pay a fee to be published, thus allowing readers to access, search, print, and cite the journals without cost. Although the OA model, in and of itself, need not diminish scientific rigor, selectivity, or peer review, the "author pays" model creates an inherent conflict of interest: it operates with the incentive on the part of the journal to publish more and reject less. This is coupled with cost containment measures that affect the journals' ability to engage experienced editors and professional staff to scrutinize data, data analyses, and author conflicts of interest. While some OA journals appear to be comparable to their print competitors, others are "predatory" and have no legitimacy at all. Two recent "scams"--one recently published in Science--highlight the urgency of addressing the issues raised by OA publication so that OA does not lose its credibility just as it begins to gather substantial momentum. High-quality journals develop their reputations over time, and OA outlets will be no exception. For this to occur, however, the OA audience will need to be satisfied that OA can deliver high-quality publications utilizing rigorous peer review, editing, and conflict of interest scrutiny. Academic tenure and promotion committees that review scholarly credentials are understandably skeptical of publications in unrecognized journals, and the large number of new OA outlets contributes to this urgency from their perspective as well.

Commentary: collaboration in dual degree programs contributes something new to both fields.

Dual degree programs in public health and law have blossomed in the United States and beyond. They are traditionally promoted on the premise that public health efforts often require legal authority to legitimize and implement their goals and objectives, and that participation of lawyers safeguards respect for individual rights, privacy, and autonomy against governmental intrusion in furtherance of public health objectives. Thus, lawyers who understand public health are far more valuable in promoting population health than traditional constitutional and administrative law practitioners without such understanding. On the public health side, epidemiologists and other practitioners trained in the law ensure that reliable data inform public policy. In the classroom, we have found that dual degree students enrich the educational experience in both fields, broadening understanding and creating conversations that transcend law or public health alone.

Pharmaceutical speakers' bureaus, academic freedom, and the management of promotional speaking at academic medical centers.

Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver "educational" talks to groups of physicians in the community to help market the company's brand-name drugs. Although presented as educational, and even though they provide educational content, these events are intended to influence decisions about drug selection in ways that are not based on the suitability and effectiveness of the product, but on the prestige and persuasiveness of the speaker. A number of state legislatures and most academic medical centers have attempted to restrict physician participation in pharmaceutical marketing activities, though most restrictions are not absolute and have proven difficult to enforce. This article reviews the literature on why Speakers' Bureaus have become a lightning rod for academic/industry conflicts of interest and examines the arguments of those who defend physician participation. It considers whether the restrictions on Speakers' Bureaus are consistent with principles of academic freedom and concludes with the legal and institutional efforts to manage industry speaking.