Drugs

Senate Report Raises Questions About Oversight of Mifepristone Providers

A new report from Senate HELP chair Bill Cassidy (R-LA) is criticizing FDA for allowing the abortion drug mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) to remain in place without requiring sponsors to conduct meaningful oversight of prescribing patterns. The report, released following a committee investigation, examined the practices of mifepristone sponsors Danco Laboratories, GenBioPro and Evita Solutions, concluding that gaps in the REMS program leave limited oversight of prescribers and could make it harder to identify violations of prescribing requirements.

Cassidy's report criticizes changes made during previous Democratic administrations that eliminated requirements for in-person dispensing and reporting of nonfatal adverse events to mifepristone sponsors. “Abortion drug companies are putting mothers at risk through their failure to properly oversee the prescription and distribution of their products,” Cassidy says in a release. He argued that FDA and drug sponsors should take additional steps to address prescribers who violate federal requirements and restore safeguards surrounding the drug.

The report points to a sharp decline in adverse-event reports following the 2016 elimination of the reporting requirement. According to the committee, more than 4,000 adverse events were reported to the FDA between 2000 and 2016, compared with 150 during the decade after the requirement was removed. The report argues that the decline raises questions about whether adverse events are being underreported.

The report calls on FDA to strengthen the REMS program, beginning with restoration of an in-person dispensing requirement. It also urges the Department of Justice to work with the agency to pursue legal options against prescribers who knowingly violate REMS requirements.

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