The Food and Drug Administration’s solicitation last week for R&D to support its Advancing Regulatory Science Initiative (ARS) has far-reaching implications for plaintiffs and defendants in drug and device litigation. It is likely that the resulting changes in regulations will impact the nature of causation and warnings evidence in court. For example, defendants could argue that it would be unreasonable to hold a manufacturer liable for adverse events that the regulatory process failed to uncover. Meanwhile, increased regulatory scrutiny may present challenges for plaintiffs pursuing claims against pharmaceutical companies and medical device manufacturers.

Through the ARS, the FDA plans to improve its ability to evaluate food, medicines, and medical devices. Last week’s solicitation clarifies the FDA’s plans for improving regulatory science – at a price tag of $200,000 to $50 million (subject to Congressional appropriations). The FDA first launched the ARS in 2010, announcing a framework for this initiative in the publication Advancing Regulatory Science for Public Health. In August 2011, the FDA released its Strategic Plan for Regulatory Science.

The Strategic Plan for Regulatory Science revealed the following eight target areas:

1.) Modernize Toxicology to Enhance Product Safety

Goal: To identify toxicity risks early in product development, assuring patient safety and avoiding the need to withdraw previously approved products.

2.) Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes

Goal: To maximize therapeutic efficacy and minimize harm by identifying predictors of individual outcomes. This component will facilitate drug and device development for special populations, such as children, women, and patients with rare or neglected diseases.

3.) Support New Approaches to Improve Product Manufacturing and Quality

Goal: To facilitate the industry’s adoption of innovative manufacturing methods and product analysis practices, reducing the cost of manufacturing and improving the FDA’s ability to rapidly evaluate a product’s safety, efficacy and quality.

4.) Ensure FDA Readiness to Evaluate Innovative Emerging Technologies

Goal: To facilitate the translation of groundbreaking scientific discoveries into effective, innovative medical products.

5.) Harness Diverse Data through Information Sciences to Improve Health Outcomes

Goal: To improve and expand the existing IT infrastructure and application of IT resources to analyze data more efficiently. Comprehensive datasets will also allow up-to-date risk-benefit balance determination at any point in the product lifecycle.

6.) Implement a New Prevention-Focused Food Safety System to Protect Public Health

Goal: To prevent food and feed safety contamination events, and if necessary, quickly respond to microbial and chemical contamination events.

7.) Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security

Goal: To establish more flexible and nimble manufacturing processes and create data, tools and methods to speed development and evaluation of MCM product safety, efficacy and quality.

8.) Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products

Goal: To equip American consumers and health professionals with the information they need to make sound decisions about using, prescribing and dispensing products.

About Innovative Science Solutions

Innovative Science Solutions (ISS) is a leading scientific consulting firm for the worldwide pharmaceutical, biotechnology, and medical device industries. We are an expert team of scientists, regulatory strategists, and consultants providing a wide range of fully-integrated services to industry and counsel including:

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