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.

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.

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.

Prescription data mining, medical privacy and the First Amendment: the U.S. Supreme Court in Sorrell v. IMS health Inc.

In 2011, the United States Supreme Court in Sorrell v. IMS Health Inc. struck down a Vermont law that would restrict the ability of pharmaceutical companies to purchase certain physician-identifiable prescription data without the consent of the prescriber. The law's stated purpose was threefold: to protect the privacy of medical information, to protect the public health and to contain healthcare costs by promoting Vermont's preference in having physicians prescribe more generic drugs. The issue before the Supreme Court was whether the Vermont law represented a legitimate, common sense regulatory program or a bold attempt to suppress commercial speech when the "message" is disfavored by the state. Striking down the law, the Supreme Court applied a heightened level of First Amendment scrutiny to this commercial transaction and held that the Vermont law was not narrowly tailored to protect legitimate privacy interests.

Transparency in research and its effect on the perception of research integrity.

Pharmaceutical companies routinely engage faculty from academic medical centers to participate in biomedical research. Faculty contribute expertise and research subjects and often receive considerable compensation for their efforts. Because the role of the researcher can be compromised by financial conflicts of interest, disclosure of such relationships is routinely required. The effect of such disclosure is not entirely clear, however, and studies have yielded inconsistent results on how those receiving financial disclosures perceive the integrity of the research. Reviewing the literature, we conclude there is little consensus on how the disclosure of a financial relationship with an industry sponsor affects confidence in the research. We also conclude that is it unclear whether the new Patient Protection and Affordable Care Act will substantially alter the landscape.

Whistleblowing in the pharmaceutical industry in the United States, England, Canada, and Australia.

Fraud and abuse in the spending of public monies plague governments around the world. In the United States the False Claims Act encourages whistleblowing by private individuals to expose evidence of fraud. They are rewarded for their efforts with monetary compensation and protection from retaliation. Such is not the case in Canada, England, and Australia. Although some recent legislation has increased the protections afforded to whistleblowers, they are still likely to be viewed more as disloyal employees than courageous public servants, and there is little incentive to risk their jobs and reputation. Qui tam laws provide a police force of thousands in the effort to reduce rampant fraud, waste, and abuse, and would be an asset in any health-care system where pubic health policy requires conservation of resources.