*Applications will be reviewed on a rolling-basis. Early submission of applications is strongly encouraged. A selection may be made at any time during the review process.
An opportunity is available at the U.S. Food and Drug Administration (FDA), Public Health Strategy and Analysis Staff (PHSA) in the Office of the Commissioner located in Silver Spring, Maryland. However, this opportunity will begin remotely while pandemic related restrictions are in place. After restrictions are lifted, the participation will be expected to complete the appointment in-person from the FDA campus.
Potential health policy and research training projects related to FDA’s domestic and/or global regulatory efforts for PHSA ORISE fellows, under the guidance of a mentor, include (but are not limited to) research and analysis of:
1. Generic drug development and competition:
The ultimate impact of generic drugs on drug prices depends not only on when FDA approves them, but also on whether and how soon generic drugs are marketed following FDA approval. Greater understanding of the current generic drug landscape and especially of the marketing status could help the FDA identify targets for action to reduce hurdles to generic drug competition and enhance price competition. The fellow may be involved in ongoing and new research that seeks to determine landscape and impact of generic drugs on competition and pricing.
2. The opioid epidemic
The fellow may be involved in research projects aimed at better understanding and combating the opioid epidemic, including impact of synthetic opioids and laws and policies that govern access to interventions for preventing and treating opioid overdose.
3. Quality of drug marketing applications submitted to the FDA:
To help improve efficiency of FDA’s drug application review and facilitate quicker entry of drugs into the market, the fellow may be involved in research projects that evaluate the quality of drug applications reviewed by the FDA to help identify deficiencies and areas of improvement.
4. Emergent issues:
The fellow may collaborate with staff members on priority research projects, such as those for COVID-19 related evidence and policy research.
If you have questions about the nature of the fellowship, please reach out to the coordinator at OPHSAFellows@fda.hhs.gov.
Anticipated Appointment Start Date: September 1, 2021; start date is flexible
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. The annual stipend range is ~$60,000 per year to ~$72,000 per year A health insurance supplement will also be provided. Limited moving or other travel-related expenses may be reimbursed. Proof of health insurance is required for participation in this program. Health insurance can be obtained through ORISE. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.