*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.
basis. Early submission of applications is s strongly encouraged. A selection may be made a at any time during the review process.
An opportunity is available at the U.S. Food a and Drug Administration (FDA), Public Health S Strategy and Analysis staff (PHSA) in Silver S Spring, Maryland.
FDA is responsible for protecting and p promoting public health through regulation o of a wide range of products including m medical products, food and tobacco. PHSA is l located in the Office of Policy, L Legislation, and International Affairs, in t the Office of the Commissioner. PHSA serves t the Agency via quantitative and qualitative r research on emerging and priority public h health issues such as opioids, drug pricing a and competition, and transparency.
Under the guidance of a mentor, potential t training projects for PHSA ORISE fellows i include research and analysis of:
1. Impact of FDA approved first generic d drugs on competition and pricing: The ultimate impact of generic drugs on drug prices depends not only on when FDA approves Abbreviated New Drug Applications (ANDAs), 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 and history of first-approved generics could help the Agency identify targets for action to reduce hurdles to generic drug competition and enhance price competition. The fellow may be involved in a multi approved generics could help the Agency identify targets for action to reduce hurdles to generic drug competition and enhance price competition. The fellow may be involved in a multi-phase study that seeks t to determine the characteristics and m marketing status of all first generics a approved by FDA since 2010, as well as their i impact on generic drug competition and p pricing.
2. Synthetic opioid epidemic Recent evidence indicates that synthetic (illicit) opioids are now responsible for more overdose deaths in the United States than prescription opioids. Based on FDA’s w work, we have a good idea of the volume of l legal opioid analgesics being prescribed for p pain in the US. However, there are very l little data from which to estimate the v volume of illicit opioids in the country, w whether produced domestically or entering t the U.S. The fellow may be involved in a r research project to better characterize the v volume and contribution of illicit, s synthetic opioids to the opioid epidemic.
3. Data from National Poison Control Centers FDA uses consolidated data from all poison control centers in the US to better understand the potential harm experienced by millions of Americans following exposure to drugs, dietary supplements, or other substances regulated by the Agency. The fellow may be assigned to undertake a new or continue an existing analysis of poison center data to better understand the public health impact of dietary supplements, anticoagulant drugs, opioids, or tobacco/nicotine products, among other FDA-relevant topics.
4. FDA’s impact on Global Health The fellow may participate in a project to help FDA better understand how the Agency has and can impact global health. One example is a potential detailed analysis of FDA’s contribution to global fight against HIV via its tentative approval program under the US President’s Emergency Plan for AIDS R Relief (PEPFAR).
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. Proof of health insurance is required for participation in this program. 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.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who h have resided in the US for a total of three o of the past five years.
FDA requires ORISE participants to read and s sign their FDA Education and Training A Agreement within 30 days of his/her start d date, setting forth the conditions and e expectations for his/her educational a appointment at the agency. This agreement c covers such topics as the following:
•Non-employee nature of the ORISE appointment;
•Prohibition on ORISE Fellows performing inherently governmental functions;
•Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
•The fact that research materials and laboratory notebooks are the property of the FDA;
•ORISE fellow’s obligation to protect and not to further disclose or use non-public information.