United Kingdom Data Deficiencies Influencing U.S. FDA Decisions
Ingrid Skop, M.D., et al., in this article, discusses the implications of the U.S. FDA permanently removing the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing prescribing through telemedicine or on-line ordering and distribution through the mail and pharmacies, without standard pre-abortion testing. This will increase the risk of complications due to failure to adequately determine the gestational age or rule out ectopic pregnancy by ultrasound or physical exam, failure to perform labs to document whether RhoGAM is indicated, and failure to obtain appropriate informed consent to prevent unwanted abortions, among other concerns. The FDA justified this action by referencing flawed studies with significantly undercounted complications. The details of these study deficiencies are examined in this article.
Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019
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Approval-Adjusted Recall Rates of High-Risk Medical Devices from 2002-2016 Across Food and Drug Administration Device Categories
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