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1of2 ‘Tara Shaver P.O. Box 50351 Albuquerque, NM 87181 Shavermissions@gmail.com September 10, 2019 MedWatch Food and Drug Administration 5600 Fishers Ln. Rockville, MD 20852 ‘To Whom It May Concern, We are writing to file a formal complaint with the Food and Drug Administration (FDA) against Franz Theard M.D., regarding a violation of the Mifeprex (Mifepristone) Risk Evaluation and Mitigation Strategy (REMS) Single Shared System For Mifepristone 200mg that was approved by the FDA in November 2018. Risk and Evaluation and Mitigation Strategies (REMS) are required by the FDA, for the use of certain medications that carry a significant risk or, in the FDA’s own language, have inherent “serious safety concerns,” in order to mitigate some of that risk. As of December 31, 2018, there have been 24-reported deaths connected with Mifeprex use. ‘Two of these deaths were attributed to ectopic pregnancies resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal. 505-1 of the FD&C Act authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS), if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks [section 505-1(a)]. In accordance with section 505-10) of the FD&C Act, a drug that is the subject of an ANDA under section 505(j) is subject to certain elements of the REMS required for the applicable listed drug. As outlined in the FDA approved REMS document (enclosed) Prescribers (Providers) of this drug must have the “ability to diagnose ectopic pregnancies).” As well as the, “Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.” In accordance with the REMS, sponsors must, “ensure that healthcare providers who prescribe their mifepristone are specially certified in accordance with the requirements described above and de-certify healthcare providers who do not maintain compliance with certification requirements.” At least two of the reported deaths could have been avoided, had the ectopic pregnancies been diagnosed, and surgical intervention been available, as required by the REMS document. 20f2 It has come to our attention that Franz Theard M.D. who operates at Hilltop Women’s Reproductive Clinic located at, 5290 McNutt Road Suite 106, Santa Teresa, NM 88008 is unable to diagnose ectopic pregnancies as required by the REMS document. This deviation from the requirements that must be adhered to in the prescriber agreement forms cannot be ignored. In accordance with Federal law, it is the sponsor’s responsibility to ensure that distributors are in compliance with the established statutes. We are requesting that the Sponsors ensure that they have on file, a current, signed prescriber agreement form for Franz Theard M.D. who operates at Hilltop Women’s Reproductive Clinic located at, 5290 McNutt Road Suite 106, Santa Teresa, NM 88008 and ensure compliance prior to dispensing the drug to the dispensers in question. We are also requesting an FDA-audit on both the suppliers and the prescribers to the ensure safety of the consumers. Provided is a recorded phone call placed to Hilltop Women’s Reproductive Clinic located at, 5290 McNutt Road Suite 106, Santa Teresa, NM 88008 that confirms Franz ‘Theard's inability to diagnose ectopic pregnancies due to lack of proper equipment. Enclosed are copies of relevant documents and correspondence we have obtained concerning this matter. These documents are: “The Mifeprex (Mifepristone) 2019 Prescriber Agreement Form for Danco Laboratories LLC. and GenBioPro Inc. - Risk Evaluation and Mitigation Strategy (REMS) Single Shared System For Mifepristone 200MG -Hilltop Women’s Reproductive Clinic website stating that they prescribe Mifeprex up to 10 weeks of pregnancy. -Recorded phone call stating that ectopic pregnancies are not diagnosed at this clinic. If you need further information or clarification regarding this complaint, I (Tara Shaver) can be reached at 505-319-7825. Thank you. Shaver {sha Armijo Martin, cc: USS. Attorney's Office District of New Mexico Centers for Disease Control and Prevention U.S. Department of Health and Human Services Drug Enforcement Administration Danco Laboratories, LLC GenBioPro, Inc. New Mexico Medical Board