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).
Drug Development
Reports
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FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time
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.
Report
The Potential Role of The Nonprofit Pharmaceutical Industry in Addressing Shortages and Increasing Access to Essential Medicines and Low-Cost Medicines
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.
Research Summary
Costs of Drug Development and Research and Development Intensity in the US, 2000-2018
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
ASPE Issue Brief
Understanding Markets for Antimicrobial Drugs
Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.
Fact Sheet, Report
Inflation Reduction Act Research Series: Understanding Development and Trends in Utilization and Spending for Drugs Selected Under the Medicare Drug Price Negotiation Program
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.
Report
Analysis of Market Challenges for Antimicrobial Drug Development in the United States
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.
Report
Antimicrobial Drugs - Market Returns Analysis
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.
ASPE Issue Brief
FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits
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.
Prescription Drug Pricing: ASPE Resources Related to Safe Harbor Rule
Department of Health and Human Services Secretary Alex Azar and Inspector General Daniel Levinson have issued a proposed rule, “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in