- Jul 28, 2016
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In what has been referred to as an effort to limit and/or test the U.S. Food and Drug Administration's (FDA) regulatory power, an investigational vaccine for herpes is being tested on the Caribbean island of St. Kitts without FDA or institutional review board approval. Clinical testing on the drug has begun. Participants included Americans flown to the island for vaccinations.
Such approval is required in the US by a board consisting of medical and administrative members whose oversight is meant to, among other things, protect participants in medical trials such as this one. An institutional review board may opt to limit or restrict a trial, require the investigators to add or delete steps to protect those being investigated (or to the protect intellectual integrity of the work being done), or even stop a trial from proceeding altogether. For example, a board may require that testing of a potentially foreseeable side effect be done on all patients in the trial.
According to Medpage Today, Augustin Fernandez III, co-founder of the company which oversaw the trial, has plans to submit the data to the FDA for approval of the drug. If not approved, he has said they will continue doing trials in other countries: https://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/67558?xid=NL_breakingnews_2017-08-28&eun=g883822d0r
Such approval is required in the US by a board consisting of medical and administrative members whose oversight is meant to, among other things, protect participants in medical trials such as this one. An institutional review board may opt to limit or restrict a trial, require the investigators to add or delete steps to protect those being investigated (or to the protect intellectual integrity of the work being done), or even stop a trial from proceeding altogether. For example, a board may require that testing of a potentially foreseeable side effect be done on all patients in the trial.
According to Medpage Today, Augustin Fernandez III, co-founder of the company which oversaw the trial, has plans to submit the data to the FDA for approval of the drug. If not approved, he has said they will continue doing trials in other countries: https://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/67558?xid=NL_breakingnews_2017-08-28&eun=g883822d0r
