The US Food and Drug Administration (FDA) hopes to obtain private sector help to improve nine areas of regulatory science, including the evaluation of generic drug effectiveness and expedited ways to assess drugs to treat the world's most dangerous diseases, the agency said this week in a new Broad Agency Announcement (BAA).
The posting of the BAA is an annual tradition for FDA. The announcement outlines the research and development topics the agency hopes to address in the coming year, with a particular emphasis on regulatory science—what FDA defines as the development of tools, standards and approaches used to better assess the safety, efficacy, quality and performance of FDA-regulated products.
Read Regulatory Focus' previous analysis of FDA's 2013 and 2014 Broad Agency Announcements.
This year's BAA comes three months earlier than it did in the two preceding years, but is similar in its focus and approach.
For example, FDA says it wants to focus on nine areas in 2015:
- Modernize Toxicology to Enhance Product Safety
- Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
- Support New Approaches to Improve Product Manufacturing and Quality
- Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
- Harness Diverse Data through Information Sciences to Improve Health Outcomes
- Implement a New Prevention-Focused Food Safety System to Protect Public Health
- Facilitate Development of Medical Countermeasures to Protect Against Threats to US and Global Health and Security
- Strengthening Social and Behavioral Science at FDA by Enhancing Audience Understanding
- Strengthening the Global Product Safety Net
That's the same focus it had in 2014, and almost the same (with the exception of #6, which is new) as 2013.
As in past years, FDA says it anticipates handing out multiple awards, and spending as much as $50 million on regulatory science provided Congress authorizes the funding.
Several areas of focus stand out within FDA's announcement.
For example, generic drug products are given ample attention by FDA within the announcement. The agency says it wants to develop "new analytical methods" to help it to evaluate the "similarity" of biosimilar products to their reference biologics. It also wants to develop "surveillance and monitoring methods" specific to generic drugs, better understand how patients perceive generic drug quality and devote more study to bioequivalence.
The announcement also specifically mentions bioequivalence problems associated with anti-epileptic drugs, immunosuppressant drugs, the antidepressant bupropion, ADHD drugs and cardiovascular drugs. All have previously been associated with bioequivalency problems, meaning they did not have the same efficacy as the brand-name drug. Related to this, FDA said it wants to "develop risk-based equivalence standards for narrow therapeutic index (NTI) drugs."
Another area of focus for FDA is on medical countermeasures—an important area following an outbreak of Ebola. Among the projects FDA hopes to support is one to "improve availability and reuse of personal protective equipment" (PPE) and another to "develop and evaluate animal models for the ability to demonstrate a response to the countermeasure that will be predictive for humans." That testing might eventually allow more drugs to be developed to treat dangerous diseases before an outbreak occurs.
Finally, FDA says it hopes to continue its investment into social research—an area Regulatory Focus has previously taken note of. Among FDA's key concerns is how information is understood by diverse groups of patients, including common regulatory terms like "voluntary recall" and "safe and effective."
Complete Listing of Project Areas
A complete listing of project sub-areas is as follows:
1. Modernize Toxicology to Enhance Product Safety
1.1 Develop better models of human adverse response
1.2 Identify and evaluate biomarkers and endpoints that can be used in non-clinical and clinical evaluations
1.3 Use and develop computational methods and in silico modeling
1.4 Develop Better Models to Investigate the Toxicology of Veterinary Drugs
2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
2.1 Develop and refine clinical trial designs, endpoints and analysis methods
2.2 Leverage existing and future clinical trial data
2.3 Identify and qualify biomarkers and study endpoints
3. Support New Approaches to Improve Product Manufacturing and Quality
3.1 Enable development and evaluation of novel and improved materials and manufacturing methods
3.2 Develop new analytical methods
3.3 Reduce risk of microbial contamination of products
3.4 Improve scientific approaches to evaluate generic drugs
3.4.1 Post-market Evaluation of Generic Drugs
3.4.2 Equivalence of Complex Products
3.4.3 Equivalence of Locally Acting Products
3.4.4 Therapeutic Equivalence Evaluation and Standards
3.4.5 Computational and Analytical Tools
3.5 Identify and Qualify Pain-Associated Biomarkers that are Associated with Therapeutic Control of Pain in Food Producing Animals
3.6 Develop a Regulatory Database for Species Identification
4. Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
4.1 Develop assessment tools for novel therapies:
5. Harness Diverse Data through Information Sciences to Improve Health Outcomes
5.1 Develop and apply simulation models for product life cycles, risk assessment, and other regulatory science uses
5.2 Analyze large scale clinical and preclinical data sets
5.3 Computer Modeling and Simulation to Assess Product Risk
6. Implement a New Prevention-Focused Food Safety System to Protect Public Health
6.1 Establish and implement centralized planning and performance measurement processes
6.2 Maintain mission critical science capabilities
7. Facilitate Development of Medical Countermeasures (MCMs) to Protect Against Threats to U.S. and Global Health and Security
7.1 Develop, characterize, and qualify animal models for MCM development
7.2 Modernize tools to evaluate MCM product safety, efficacy, and quality
7.3 Identify and qualify biomarkers of diseases or conditions
7.4 Enhance emergency communication
8. Strengthening Social and Behavioral Science at FDA by Enhancing Audience
8.1 Assessment of how communications are understood, especially among diverse audiences and populations, and methods to improve the comprehension of content, including numerical information.
8.2 Exploration of how FDA communications can best complement those communicated by industry to enhance audience comprehension.
8.3 Research to assess public understanding of the regulatory terms in use.
8.4 Evaluation of timing of release of recall or warning messages, when the messages should be changed to enhance impact, and how to communicate the end of a recall or warning.
8.5 Studies to increase the safety of post approval drug use
9. Strengthening the Global Product Safety Net
9.1. Advancing Global Public Health
9.2. Leveraging and Collaborating
9.3. Analyzing and Utilizing Global Data to Manage Risks
9.4. Manage Risks Related to Intentional Disruptions to Food Supply