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This document is a preface to a special issue of the journal Pharmaceutics on the topic of drug transporters and their regulation and roles in therapeutic strategies. The preface provides an overview of the importance of drug transporters in human physiology and diseases, as well as in the efficacy of medicines. It highlights several articles included in the special issue that cover various aspects of drug transporters, including their structure, function, regulation, and impact on drug interactions and diseases. The preface expresses gratitude to the authors for their contributions to the field of drug transport. [Extracted from the article]

Pharmaceutical sector corruption undermines patient access to medicines by diverting public funds for private gain and exacerbating health inequities. This paper presents an analysis of UN Convention Against Corruption (UNCAC) compliance in seven countries and examines how full UNCAC adoption may reduce corruption risks within four key pharmaceutical decision-making points: product approval, formulary selection, procurement, and dispensing. Countries were selected based on their participation in the Medicines Transparency Alliance and the WHO Good Governance for Medicines Programme. Each country’s domestic anti-corruption laws and policies were catalogued and analysed to evaluate their implementation of select UNCAC Articles relevant to the pharmaceutical sector. Countries displayed high compliance with UNCAC provisions on procurement and the recognition of most public sector corruption offences. However, several countries do not penalise private sector bribery or provide statutory protection to whistleblowers or witnesses in corruption proceedings, suggesting that private sector pharmaceutical dispensing may be a decision-making point particularly vulnerable to corruption. Fully implementing the UNCAC is a meaningful first step that countries can take reduce pharmaceutical sector corruption. However, without broader commitment to cultures of transparency and institutional integrity, corruption legislation alone is likely insufficient to ensure long-term, sustainable pharmaceutical sector good governance. [ABSTRACT FROM AUTHOR]

Background: The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster, but it is unknown whether these drugs also improve overall survival (OS) for patients taking them. Methods: We sought to estimate the percentage of oncology drugs that have shown to improve OS in a cross‐sectional analysis of US FDA oncology drug approvals (2006–2023). We searched for OS data in registration trials and the peer‐reviewed literature. Results: We found 392 oncology drug approvals. Eighty‐seven (22%) drug approvals were based on OS, 147 drug approvals were later tested for OS benefit (38% of all approvals and 48% of drugs approved on a surrogate), and 130 (33%) have yet to be tested for OS benefit. Of the 147 drug approvals later tested for OS, 109 (28% of all approvals and 74% of drugs later tested for OS) have yet to show OS benefit, whereas 38 (10% of all approvals and 26% of drugs later tested for OS benefit) were later shown to have OS benefit. In total, 125 out of 392 (32%) drugs approved for any indication have been shown to improve OS benefit at some point, and 267 (68%) have yet to show approval. Conclusion: About 32% of all oncology drug approvals have evidence for an improvement in OS. Higher standards are needed in drug regulation to ensure that approved drugs are delivering better patient outcomes, specifically in regards to survival. [ABSTRACT FROM AUTHOR]

In several controversial drug approval decisions in recent years, the Food & Drug Administration ("FDA") has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the Agency's determination whether a drug is "safe" and "effective" does not seem to depend on whether its approval also supports innovation. But FDA'suse of these innovation arguments in drug approval decisions is just one example of the ways in which the Agency has come to make many innovation-related judgments as part of its regulation of drugs. In this Article, we investigate the broad set of innovation-related judgments that FDA has been making and argue that there are serious concerns with the major innovation role FDA has been playing, at least as the Agency is currently constituted. We conclude that FDA should not separately weigh innovation in decisions about a product's safety and effectiveness. In other areas, health policymakers could reasonably decide that FDA should have either a larger or a smaller role than it currently does in shaping the development of novel drugs. But policymakers should do so while thoughtfully considering both the opportunities and challenges of FDA actively considering innovation incentives in its decisions; those challenges have been rarely considered in the literature and policy discourse. Further, we argue that whether policymakers aim to bolster or limit the ways that FDA considers innovation in its regulatory decisions, changes are needed to the Agency's structure to support its ability to make reasoned judgments based on relevant expertise. [ABSTRACT FROM AUTHOR]

Background: Drug use is a major public health issue in India. Significant changes in the approach toward drug use have happened in the last few decades. Despite this, no systematic attempt has been made to document the same in the scientific literature. This narrative review attempts to discuss the major drug laws, policies, and national programs of the Government of India (GoI). Methods: A thorough search was conducted to look for policies, programs, acts, and notifications related to substance use/drug use on various websites of different ministries of the GoI. Acts, programs, and policies addressing substance use were identified. Results: Various drug laws, programs, and acts from the GoI provide a multipronged approach to curbing the procurement of drug use along with its prevention and cure. The Ministry of Social Justice and Empowerment (MoSJE) is the nodal ministry for drug demand reduction. The enactment of the Narcotic Drugs and Psychotropic Substances (NDPS) Act 1985 and Policy 2012 and the implementation of India's Drug De-Addiction Program (DDAP) are important landmarks in this journey. Conclusion: The GoI initiatives for reducing the mental health burden in this country in general and substance use disorders (SUDs), in particular, are immense. The acts/statutes/laws/notifications are all interlinked. Stakeholders in mental health, public health, and policy-making need to upgrade themselves with the relevant statutes to curb the menace of drug use. [ABSTRACT FROM AUTHOR]