[Pharmwaste] FDA adding reseacher to guide research/regulation of drugs w/ Estrogenic, Androgenic, or Thyroid Activity

Laurenson, James James.Laurenson at fda.hhs.gov
Thu Sep 3 10:52:03 EDT 2015

Thanks Ed for advertising this! And, while rhetorical, you raise some good questions about the scope of the fellowship (and about us maybe needing more staff...or pay! :) ). A key clarification is that the participant would not be guiding the research/regulation of drugs w/E, A, or T activity or the other topics noted. Rather, the appointment is an educational opportunity, as described more at http://orise.orau.gov/fda/current-research-participant/nature-of-appointment.htm, which would involve working with CDER staff as well as with other FDA Centers and other agencies on a variety of research topics, with EAT activity the main focus given the new draft guidance.

Regarding the one year appointment, this is routine for ORISE. They can be extended in increments of up to one year, up to a total of four (postgrad.) or five (postdoc.) years, contingent upon project needs and funding. See "How to renew a participant" in the sidebar of the above link. And yes, health insurance is required, but it can be purchased through ORISE at reasonable rates (see "Insurance" at the link above).

If anyone has any questions about the position, please let me know.


James Laurenson / Environmental Officer, Toxicologist  / Center for Drug Evaluation & Research / U.S. Food & Drug Administration / 10903 New Hampshire Ave., Bldg. 21, Rm. 1626 / Silver Spring, MD  20993 / 301-796-4872 (office) / 703-342-9496 (cell) / james.laurenson at fda.hhs.gov<mailto:james.laurenson at fda.hhs.gov>

From: pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us> [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Ed Gottlieb
Sent: Tuesday, September 01, 2015 2:29 PM
To: pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: [Pharmwaste] FDA adding reseacher to guide research/regulation of drugs w/ Estrogenic, Androgenic, or Thyroid Activity

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.
The new EA draft guidence, Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity, informs drug applicants that recent research indicates that some drugs with hormonal activity in the environment may exhibit "extraordinary circumstances" and that the Agency may require additional ecotoxicity testing for applications submitted for drugs with hormonal activity.  In addition, antimicrobial, additivity/synergism, nanotechnology, and other properties have been implicated for possible adverse environment effects, as well as human effects through environmental pathways.  Also, other Centers (e.g., CVM), agencies (e.g., EPA), and regions (e.g., EU) have begun addressing these issues through research, guidance, and regulatory development.  The EA Staff requires support for research and implementation to address these issues.

Rhetorically, I wonder how big the FDA research staff is that they are only adding one temporary position to help cover the huge range of tasks spelled out in the job announcement (link above)?  Who would take on such a daunting task, knowing they have to do it in only one year?  And, as a consultant, they have to provide their own health insurance.
Ed Gottlieb
Chair, Coalition for Safe Medication Disposal
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY  14850
(607) 273-8381
fax: (607) 273-8433
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