Drugs

Lawmakers Concerned About Loosened Mifeprex Standards

Some 75 members of the House and Senate from both parties are expressing concern that FDA has loosened standards governing use of the abortion drug Mifeprex, also known as RU-486. In a 4/25 letter to FDA commissioner Robert Califf, the lawmakers say that the drug’s original approval process was extremely controversial and that since its approval it has been associated with serious adverse events, including hemorrhaging, severe infections, and even deaths of women who have taken it.

Given recent changes to the FDA-approved regimen for using the drug and its Risk Evaluation and Mitigation Strategy, the lawmakers ask for this information:

a “thoroughly updated” postmarketing adverse events summary including any reported deaths associated with Mifeprex through 12/2015;
a list of all applications submitted to FDA since 2000 by Danco Laboratories, including but not limited to the recently approved application to loosen standards governing use of Mifeprex;
a timeline of agency actions associated with Danco’s application to loosen standards governing the use of Mifeprex, including any review by the Bone, Reproductive, and Urologic Drugs Advisory Committee;
a copy of all documents, studies, and other evidence used to assess the safety and efficacy of the Mifeprex changes announced 3/30/16;
a copy of any transcripts or notes from consideration of Danco applications by the Bone, Reproductive, and Urologic Drugs Advisory Committee;
the locations where Mifeprex is manufactured and/or packaged and a list of all FDA safety reviews of these locations in the past 15 years, including any site visits conducted by FDA or at the request of the agency;
a copy of all communications between Califf or any member of the agency staff and the White House and/or the office of the HHS secretary regarding the drug or “medication abortion”; and
a copy of all communications between Califf or any member of the FDA staff and any non-governmental entity such as Planned Parenthood, ACOG and Gynuity about the drug or “medication abortion.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome