Drugs

Group Seeks Removal of ‘Conflicted’ Panel Member

Consumer-health advocacy group Citizens for Health has urged FDA commissioner Scott Gottlieb to remove a Pew Charitable Trusts representative from the agency’s Pharmacy Compounding Advisory Committee (PCAC) due to alleged conflicts of interest in Pew’s lobbying support for pharmaceutical company interests. PCAC was created in 2014 and makes recommendations to FDA on ingredients and categories of medications that can be used in human compounding. It is made up of 12 voting members, and two non-voting members; Pew holds a voting seat.

“Pew has lobbied side by side with Big Pharma and drug company interests and has lobbied side by side with them in a way that promotes the interests and profits of these companies over the public good,” Citizens for Health said. The group said Pew has acted as a co-signatory with several pharmaceutical trade and public health groups in communications to Congressional members disparaging the practice of pharmacy compounding and calling it unsafe.

Pew director of public health and PCAC panel member Elizabeth Jungman told FDA Webview that her group has a long history of working on drug compounding issues. She said Pew does not accept any financial support from the pharmaceutical industry. Jungman also noted that FDA has rigorous processes and guidelines for choosing committee members and preventing conflicts of interest on panels like PCAC.

Interestingly, Jungman testified 1/30 at a House Energy and Commerce subcommittee hearing on drug compounding and warned that weakening the Drug Quality and Security Act (DQSA), which called for tighter controls on compounding, would threaten patient safety. During her testimony, she shared some new findings showing that the DQSA is spurring better compounding oversight in states.

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