Drug Development

Rare cancer clinical trials appear to enroll less diverse participants than clinical trials more broadly and therefore may require additional considerations or unique solutions to diversify participant recruitment. These differences persisted within both NIH and non-NIH funded trials.

The cost of bringing a medical product to the U.S. market has been increasing and clinical trials constitute a large portion of these costs. In drug development, the clinical phase lasts an average of around 95 months compared to 31 months for the non-clinical phase and accounts for 69 percent of overall R&D costs (DiMasi, et al., 2016).

This landing page presents the abstract of a paper published in Health Affairs. The full text of the article is available at: https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2023.00837.

We report findings of a study that described the emerging nonprofit pharmaceutical industry and its commercialization activities to enhance access to affordable and essential drugs, or resiliency in the supply chains of medical products.

This landing page represents the abstract of a paper published in JAMA. The full text of the article is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820562.Abstract

Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.

The Inflation Reduction Act (IRA) authorizes the Secretary of the Department of Health and Human Services (HHS) to negotiate prices directly with participating manufacturers for selected drugs that are high expenditure, single source drugs without generic or biosimilar competition.

The market for antimicrobial (AM) drugs is unique in that it is associated with a positive externality (public health) as well as a negative externality (antimicrobial resistance, or AMR) (Mossialos, et al., 2010). AMR occurs when microbes change over time and no longer respond to available medicine.

In 2017, at least 2.8 million people in the U.S. acquired serious infections with bacteria that are resistant to one or more antimicrobial drugs and 35,000 have died as a result. Resistance to antimicrobials is viewed as a global threat with antimicrobial drug use in human and animal health driving resistance.

This issue brief provides a primer on FDA user fees, presents findings of how user fees affect the cost of medical product development, and summarizes the research literature on user fees, most notably in expediting medical product development and approval.