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.
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.
Goal: To identify toxicity risks early in product development, assuring patient safety and avoiding the need to withdraw previously approved products.
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.
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.
Goal: To facilitate the translation of groundbreaking scientific discoveries into effective, innovative medical products.
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.
Goal: To prevent food and feed safety contamination events, and if necessary, quickly respond to microbial and chemical contamination events.
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.
Goal: To equip American consumers and health professionals with the information they need to make sound decisions about using, prescribing and dispensing products.
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