Drugs

Watchdog Group Wants Teva Probe Transparency

The citizen watchdog group Accountable.US says it is concerned about a lack of transparency from the Justice Department (DoJ) in its investigation of alleged price-fixing of generic drugs by Teva. In a 6/16 letter to attorney general William Barr, the group says it is concerned “since the recent passage of a key statute of limitations deadline as well as the possibility that Teva’s attempts to curry favor with President Trump has impacted this investigation and could represent another example of DoJ decisions being influenced by political pressure.”

Accountable.US asks for answers to these questions:

the current status of the DoJ investigation into price-fixing by Teva Pharmaceuticals;
if there was an agreement reached between DoJ and Teva to extend the statute of limitations, will the details of that agreement be released, including information on the new deadline as well as who from DoJ was involved in the negotiations with Teva;
what role, if any, did DoJ leadership, the White House, or other political appointees play in any negotiations with Teva or internal DoJ decisions regarding the price-fixing case; and
what role, if any, did Teva’s donations of hydroxychloroquine play in the price-fixing investigation, negotiations between DoJ and Teva, or any DoJ decisions regarding the 5/31 statute of limitations deadline.

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