Larry M. Simonsmeier Writing Award
The American Society for Pharmacy Law (ASPL) is a nationwide organization with the purposes of: (i) furthering knowledge in the law related to pharmacists, pharmacies, the provision of pharmaceutical care, the manufacturing and distribution of drugs, and other food, drug, and medical device policy issues ("Pharmacy Law"); (ii) communicating accurate legal educational information; and (iii) providing education opportunities for pharmacists, attorneys, and others who are interested in Pharmacy Law.
ASPL recognizes outstanding scholarship related to Pharmacy Law with the Simonsmeier Award. The Award recognizes an outstanding paper relating to the interests of ASPL published during the prior two years (2013-2015). The 2016 Award includes an honorarium plus support for travel to the ASPL Developments in Pharmacy Law Seminar XXVII in Austin, Texas, November 9-13, 2016.
The Award is named in honor of the late Larry Simonsmeier (1944-2009), who was a pharmacist and attorney, professor and dean of Washington State University College of Pharmacy, president of ASPL, and editor of the Rx Ipsa Loquitur for more than twenty years.
Papers related to Pharmacy Law, as defined above, published in or accepted for publication in any English-language peer-reviewed journal (including law reviews) during the period from January 2013 through December 2015 are eligible. Interested parties are invited to nominate published papers written by themselves or other authors. Authors may submit manuscripts that are in press.
Submission of Nominations
Nominations should provide the name, address, daytime telephone number, and e-mail address of the nominator, a reprint of the full paper, and a complete journal citation for the paper being nominated. If an author is submitting a manuscript that is in press, the copy of the manuscript should be accompanied by documentation from the journal editor of the status of the paper, and should include contact information for the journal editor. The deadline for submission of nominations for the Larry M. Simonsmeier Award is June 30, 2016.
Nominations should be addressed to:
Education & Scholarship Committee
Questions may be directed to ASPL at:
August 11, 2016
GENETICALLY ENGINEERED MOSQUITOS
FDA issues Finding of No Significant Impact for Oxitec's genetically engineered mosquitos; anti-Zika trials scheduled for Florida
On August 5, the FDA released a final environmental assessment for genetically engineered (GE) mosquitos produced by the British biotechnology firm, Oxitec. The assessment included a Finding of No Significant Impact (FONSI) for a proposed field trial of the mosquitos in Florida. The Oxitec mosquito strain, OX513A, consists of male Aedes aegypti mosquitos with a self-limiting gene modification, who mate with wild females and produce offspring incapable of survival. Aedes aegypti strains carry the Zika virus, and reductions in their populations is key to controlling spread of the virus in the US.
The modified gene produces a protein, tTAV (tetracycline repressible activator variant), which blocks expression of other mosquito genes, thus rendering the mosquito incapable of survival. Larvae for male mosquitos, which do not bite, are separated from female larvae, and grown in an aqueous environment containing tetracycline, which suppresses production of tTAV. Offspring in the wild, however, will not be exposed to sufficient levels of tetracycline and will die. Neither the tTAV protein nor other proteins produced in the nonviable offspring are toxic, and thus animals consuming the offspring are not affected.
Trials of GE mosquitos in Piracicaba, Brazil, demonstrated significant reductions in populations of wild-type Aedes aegypti strains, and a 91% drop in cases of dengue fever, according to an Oxitec press release in mid-July. The FDA's FONSI will allow trials to begin in Key Haven, FL, but large-scale marketing of the organism will require further FDA review. [USDHHS, FDA. FDA releases final environmental assessment for genetically engineered mosquito; 2016 Aug 5; http://bit.ly/1McvLMg; Oxitec Ltd., Technology; http://bit.ly/2aMKVeF, accessed 11 Aug 2016]
2016 DPLXXVII Seminar
November 10-13, 2016