Drugs

Hill Seeks Answers to Confidentiality After Insider Trading Scandal

House Energy and Commerce Committee chairman Fred Upton (R-MI) and Health Subcommittee chairman Joseph Pitts (R-PA) have written FDA seeking answers about its procedures for protecting product trade secret and confidential information in the wake of a recent insider trading scandal involving the Office of Generic Drugs. Earlier this month, former FDA Office of Generic Drugs deputy director and now consultant Gordon Johnston pled guilty and admitted his role in an insider trading scheme that obtained highly confidential and material nonpublic information from a senior FDA official about the status and impending approval of generic enoxaparin (Sanofi-aventis’ blockbuster Lovenox). According to government and court documents, the information that Johnston illegally obtained was passed on to hedge fund managers who used it to make stock trades in violation of insider trading laws and regulations.

The committee had written FDA earlier this year expressing concerns about the agency’s procedures for protecting trade secret and confidential information. The lawmakers said a 5/6/2016 FDA reply did not provide detailed information. “From your initial response, it is clear that FDA has some procedures in place to protect trade secrets and confidential information. However, your response does not address how effectively FDA has implemented those procedures and controls, or how FDA audits employee compliance with these controls,” wrote Upton and Pitts. They now request additional information on the effectiveness of security measures, how FDA monitors compliance, and what additional steps the agency is taking in light of the recent insider trading scandal.

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