A holistic view of innovation incentives and pharmaceutical policy reform.

The Inflation Reduction Act is set to transform how Medicare pays for prescription drugs, most notably by enabling Medicare to negotiate for the prices of certain high-cost medications. The pharmaceutical industry argues it will drastically reduce innovation, but a full analysis of its impacts on innovation requires considering not merely the number of new drugs produced but their clinical value. Several features of the negotiation process aim to minimize its impacts on innovation, particularly for drugs with high clinical value.

Opportunity for Reduction of Intensive Care Unit Resource Utilization in Pediatric Blunt Liver and Spleen Injuries: A National Trauma Data Bank Analysis.

Introduction: Guidelines for blunt liver and spleen injury (BLSI) by the Arizona-Texas-Oklahoma-Memphis-Arkansas Consortium (ATOMAC) emphasize hemodynamic stability over injury grade when considering non-operative management (NOM). In this study, we examined rates of intensive care unit (ICU) admission for children with isolated low-risk BLSI among US hospitals.

Methods: The National Trauma Data Bank (NTDB) was queried for patients ages 1-15 admitted between 2017 and 2019 with BLSI.

Extending the US Food and Drug Administration's Postmarket Authorities.

Importance: The US Food and Drug Administration (FDA) has expansive regulatory flexibility regarding the quality and quantity of evidence it deems sufficient to approve new drugs, which has been increasingly used to grant approval based on less certain evidence of benefit. However, the FDA's regulatory flexibility with respect to standards for approval has not been matched by sufficient stringency in its exercise of postmarket safeguards, including the FDA's authority and willingness to require confirmation of benefit through postmarket efficacy studies or to withdraw approval when benefit is not confirmed.

Objective: To identify and evaluate opportunities for the FDA to extend its authority to require postmarket efficacy studies and use expedited withdrawal procedures for drugs approved despite substantial residual uncertainty outside the accelerated approval pathway.

Reforming Reimbursement for the US Food and Drug Administration's Accelerated Approval Program to Support State Medicaid Programs.

Importance: The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA's oversight of the program but also for its implications for payers.

Observations: State Medicaid programs' legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry's changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA's accelerated approval pathway and product regulation without taking into account the implications of this pathway for state Medicaid programs.

Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval.

Importance: State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs.

Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits.

Many state Medicaid officials are concerned about rising prescription drug spending, particularly drugs approved through the Food and Drug Administration's (FDA) accelerated approval pathway. The authors examined how much of Medicaid programs' accelerated approval spending is attributable to products that have demonstrated clinical benefits versus those that have not. Their findings provide support for states' concerns that pharmaceutical companies often fail to complete their required postapproval confirmatory studies within the FDA's requested timeline.

Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure.

This cross-sectional study examines changes in hydroxyprogesterone caproate fills from 2010 through 2020.

The Rhetorical Transformations and Policy Failures of Prescription Drug Pricing Reform under the Trump Administration.

Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language to criticize the pharmaceutical industry and its practices but also introduced ambitious reform policies that had previously lacked acceptance among Republican policy makers. President Trump appears to have been successful in developing a new populist form of rhetoric that Republicans can use in support of novel drug pricing reforms such as the ones his administration considered.

How The ACA Reframed The Prescription Drug Market And Set The Stage For Current Reform Efforts.

The Affordable Care Act contained a range of provisions that altered prescription drug access and affordability for patients, payers, and providers. Yet the act stopped short of instituting systemic changes in the pricing of drugs, in part to address concerns that more fundamental changes might disrupt the development of new medicines. Looking back a decade after the Affordable Care Act became law, we found that new drug approvals have accelerated and the therapeutic advances embodied in some novel medicines are substantial-as are the prices that companies are charging for them.