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By Brian Booth and Vikram Arya

Brian Booth-finalVikram Arya-finalDuring drug development, assessing the impact of food on the absorption and behavior of oral medications and determining the appropriate dosing instructions that optimize the safety and efficacy of the product is critically important. As an aid in the design of these studies, the Food and Drug Administration (FDA) published the Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies in 2002. Over the past decade, the complexity of food interactions with drugs has manifested in several different ways, such as the variable impact of when meals are consumed relative to dosing, or the effects of different types of meals on medicines. The agency is revising and updating the guidance to meet the needs of drug development today.

In the course revising the food effect guidance, FDA is considering a number of different questions such as:

  • Are there circumstances in which food effect studies can be waived during drug development?
  • Can we standardize meal content across the various food effect studies?
  • How do we communicate dosing information to patients and health care practitioners?
  • How can we optimize the value and timing of food effect studies during drug development?
  • What issues need to be considered specifically for pediatric, geriatric or specific patient populations?

An important aspect of this revision is to gather feedback from the scientific community on issues related to the design, interpretation and communication of the impact of food on the clinical pharmacology of medications. To that end, the FDA is partnering with the American Association of Pharmaceutical Scientists (AAPS), the American Society for Clinical Pharmacology and Therapeutics (ASCPT), and the American College of Clinical Pharmacy (ACCP) to hold a two-and-a-half-day workshop in order to seek the input of industry, academia, other government scientists, and health care advisers on their experiences with food effect studies. The workshop, Evaluating and Modernizing Our Approaches to Food-Effect Assessment, will be held February 2-4 in Baltimore, Maryland, will include speakers from a variety of sectors in pharmaceutical science, and will offer participants the opportunity to participate in the feedback process.

Brian Booth, Ph.D., is Deputy Director, DCP V, at FDA/CDER/OTS/OCP.
Vikram Arya, Ph.D., FCP, is a Senior Clinical Pharmacology reviewer, DCP IV, at FDA/CDER/OTS/OCP.