The Role of the Food Drug Administration (FDA) in Clinical Drug Trials

In the U.S., the Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

In other parts of the world, similar regulators exist with similar goals, such as the European Medicines Agency. A key component of the FDA mission is to protect the public health by assuring the safety of human drug products. Supporting this objective, FDA is also responsible for advancing public health by facilitating the scientific innovations that can help make medicines safer while assuring that the public receives clear, accurate, science-based drug safety messages.

Another kind of drug safety issue emerges when drug products are misused— not used as directed, or used inappropriately after being prescribed. This is the case with the national opioid abuse and addiction crisis. What can go wrong with drug products after approval, but before and during distribution to pharmacies, clinics, and hospitals across America? Many things, from inherent defects in product design, to failures in drug product manufacturing related to outmoded equipment or aging manufacturing facilities pressed beyond capacity, or inadequate or ineffective on-site quality management systems.

In addition to these sorts of direct concerns related to manufacturing problems, production slow-downs or failures can create drug shortages—many of which involve critically needed life-saving medicines used in hospital emergency departments and operating rooms. CDER’s drug quality oversight is now structured to streamline regulatory processes and align areas of expertise by integrating review, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale.

The FDA is also responsible for advancing public health by helping to speed innovations that make medicines more effective, safer and more affordable, and by helping members of the public get the accurate, science-based information they need to use medicines to maintain and improve their health. 

As profound new insights into disease processes at cellular and molecular levels operate in the technologically advanced environments of distributed digital networks, data mining, custom-built software platforms, and mobile device applications, drug safety science is taking on ever more powerful potential to predict, detect, and prevent drug related adverse events.

The FDA uses a broad range of methods to communicate drug safety information to the public. Certain forms of communication are targeted to specific audiences (for example, health care providers or patients). Americans receive as many as 3 billion prescriptions for pharmaceuticals each year, and millions receive medical devices such as hip and knee implants.

The Sentinel System is a national, integrated electronic system for monitoring drug safety through shared health care databases (with care taken to protect personal health information). Sentinel leverages “big data” and broad networks across many data partners to systematically detect and respond to emerging risks associated with FDA-regulated medical products—allowing evaluation of safety issues more rapidly than has been possible in the past.

All medications and medical devices come with inherent risks, but it is the FDA’s duty to address serious risks that can be avoided and managed. Others are directed toward more than one group to ensure widespread communication of information about important drug safety issues, including emerging drug safety issues.

After a newly-approved drug enters the marketplace, postmarketing experience can reveal adverse events (AEs) not detected during clinical trials or preapproval review. FDA maintains two major systems for postmarketing drug surveillance, a “passive” system known as FAERS (FDA Adverse Event Reporting System) and an “active” system known as the Sentinel System.

One key tool employed to characterize and evaluate adverse effects (AEs) is  FAERS, an electronic data base of spontaneously submitted adverse events  (AEs) associated with drugs and biologic products. For the past 47 years, spontaneous reporting has been the cornerstone of CDER’s postmarketing drug safety monitoring, based on voluntary MedWatch reports from the public, healthcare professionals, and others, of AEs, drug quality problems, or medication errors they observe during the use of a marketed drug product.

Seven major areas of safety related needs:

✔️Improve access to postmarket data sources and explore the feasibility of their use in analyzing safety signals.

✔️Improve risk assessment and management strategies to reinforce the safe use of drugs.

✔️Evaluate the effectiveness of risk communications of drug safety information to health care providers and the public.

✔️Improve product quality and design, manufacturing processes, and product performance relating to safety.

✔️Develop and improve predictive models of safety in humans.

✔️Improve clinical trial statistical analyses for safety, including benefit-risk assessments.

✔️Investigate clinical biomarkers (see sidebar) of safety, including standards for biomarker qualification.

In the Division of Applied Regulatory Science (DARS), researchers using state-of-the-art equipment and technologies are applying a wide range of expertise in areas such as toxicology, pharmacology, biophysics, chemistry, genomics, and computational modeling, in the service of developing new and innovative approaches that will improve CDER’s drug product review capabilities.

DARS scientists provide:

✔️Improved lab assays for predicting drug safety

✔️Better understanding of the mechanisms underlying drug toxicity

✔️Insights into the links between a drug’s chemical structure and its potential to induce adverse events

✔️Research-based predictions that can be used to support decisions for new and generic drugs when safety data are limited

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Creating the cutting-edge scientific knowledge base needed to support 21st Century safety science requires an understanding of the knowledge gaps in product safety, the resources that can be leveraged to address those gaps, and the necessary expertise of internal and external partners. This effort cannot be done alone but rather requires partnerships between FDA and multi-sector stakeholders sharing the common goal of promoting drug safety and effectiveness to protect and improve public health.

Patients, caregivers, health care professionals, and the public are updated on new drug safety information with Drug Safety Communications (DSCs). These messages and announcements can range from new or emerging risks associated with concurrent conditions (for example, pregnancy or existing liver or kidney disease), or cautions about potential medication errors. DSCs contain actionable recommendations for patients and health care professionals that can help them make more informed decisions, and prevent or mitigate drug-related harm. DSCs are usually issued in conjunction with regulatory actions such as Safety Labeling Changes for a number of reasons, including issues affecting a large number of patients, potentially serious or life-threatening adverse events, or medication errors that may result in serious or life-threatening adverse reactions.

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