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Product: Mifeprex®(misoprostal) Tablets
Company: Danco Laboratories
Petition Filer: American Association of Pro-Life ObGyns
Petition Number(s): 2019P-1534
Date of Petition: April 1, 2019
Responding Petitions:Issue and Implication: Whether the REMS programs can be revised back to its original guidelines once modified.
Action Requested by Petitioner: The Petitioner is requesting that the Risk Evaluation and Mitigation Srategy (REMS) for this product be taken back to its original format and take additional steps to ensure safe dispensing and use of this product.
Summary of Petition(s): Approved in 2000, Mifeprex®(misoprostal) is used to terminate pregnancies. Originally prescribed before the 49th day of gestation, the REMS program was modified to allow for up to 70 days as well as changing from an oral medication to buccal. In addition, over the years, standards of care have declined for these patients, and there have been more recent studies over the last few years showing adverse events, additional risks of usage multiple times and patients under 18 using the medication.
As such, petitioner is asking FDA to return to the original usage in patients up to 49 days of gestation until further studies can be done to address the issues of age and adverse events, particularly for multiple treatments. Moreover, petitioners would to strengthen the REMS procedures to require that the product be administered only in clinical settings under the care of medical professionals (ie doctors). There have been reports of telemedicine calls to administer these patients, and this is insufficient. The doctor must also eliminate any other complications (such as ectopic pregnancy) and the patient should also be physically present. These are truly minimal requirements to ensure that the product is used safely and appropriately.
FDA Action: On December 17, 2021, FDA issued its response. While it granted certain portions (to continue the REMS programs and safety monitoring), it essentially denied the petition.
Product: Mifeprex®(misoprostal) Tablets
Company: Danco Laboratories
Petition Filer: American College of OBGYNs
Petition Number(s): 2022P-2425
Date of Petition: October 6, 2022
Responding Petitions:Issue and Implication: Whether FDA can force a sponsor to conduct additional studies and whether FDA can remove a REMS (Risk Evaluation and Mitigation Strategy) program.
Action Requested by Petitioner: The Petitioner asks FDA to require Danco Laboratories to conduct additional studies to add a “miscarriage management” indication and also to modify or eliminate the current REMS program.
Summary of Petition(s): In what is a vaguely worded and euphemism-filled petition, it is not overwhelmingly clear what petitioner is asking for. It asks FDA to require Danco to conduct additional studies to add an indication of “miscarriage management” without really stating what the indication should be. Moreover, it then asks FDA to modify or perhaps eliminate the REMS program without stating what the current REMS program is (see above petition.)
Once reading “between the lines” of this petition, it becomes clear that the petitioner is seeking to use this medication to for anytime abortions. The medication is used to terminate pregnancies (in other words, initiate miscarriages) but has certain restrictions of prescribing through its REMS program and 70 day limitation. The Petitioner argues that using the product anytime during the first semester (and perhaps later) is supported by studies, and it also makes the claim of “health equity” that poor minorities are affected by lack of “miscarriage management” than white patients.
FDA Action: On January 4, 2023, FDA denied this petition.
©2022 Parry Ashford Inc
Gregory Glass
FDA Petitions
