FDA Environmental Assessment of Human Drugs Fellowship

A research opportunity is available in the Office of Pharmaceutical Quality/Office of New Drug Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions. To comply, FDA implements 21 CFR Part 25, which includes a requirement for an environmental assessment (EA) if “extraordinary circumstances” indicate that the specific proposed action may significantly affect the quality of the human environment. FDA is implementing new EA guidance that informs drug applicants that some drugs with hormonal activity in the environment may exhibit extraordinary circumstances and that the Agency requires additional ecotoxicity testing and screening tools for applications submitted for drugs with hormonal activity. In addition, antimicrobial, additivity/synergism, and other properties have been implicated for possible adverse environmental effects, as well as human effects through environmental pathways. Public inquiries also have increased in recent years regarding the environmental impact of drugs, including those on the so-called "flush list" at www.fda.gov/drugdisposal. Other Centers (e.g., CVM), agencies (e.g., EPA), and countries (e.g., EU), as well as academia and industry, have been researching these issues and providing data and analyses that need review.

This project will investigate and characterize the ecological and public health relevance of drugs in the environment across key areas, including drugs with common mechanisms of action, hormonally active drugs, antimicrobial resistance, generics, and over the counter, taking into account cumulative/additive exposure and nonconventional toxicity endpoints. The participant will learn about a variety of areas within regulatory science, and in particular the key properties (e.g., antimicrobial resistance, additivity/synergism) that could contribute to significant risk under NEPA. The participant also will understand the first steps that would need to be taken to develop effective mitigations, while also learning about the context of available resources and regulatory structure, policies, and guidance. Finally, the participant will better understand the need for harmonization with other Centers, agencies, and countries/regions.

The qualified candidate should be currently pursuing or have received a bachelor's, master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. 

Preferred skills:

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0510) in your email.