Drugs

Lawyer’s Motion to Remain Anonymous Granted

The DC District Court has temporarily granted an attorney’s motion to keep his identity secret (see earlier story) in connection with a form FDA-483 that was scheduled to be published. The suit, which lists J. Doe as the attorney, says the agency intended to publish the FDA-483 “despite plaintiff’s detailed explanation to FDA as to why plaintiff’s identity should be redacted, given that the release of plaintiff’s identity is unnecessary, contrary to law, inconsistent with agency precedent, and harmful to plaintiff.” The court noted in granting the motion that its decision is “subject to any further consideration by the United States district judge to whom this case is randomly assigned.”

The unprecedented court opinion found that at this early stage, the plaintiff has met his burden to show that his “privacy interests outweigh the public’s presumptive and substantial interest in learning his identity.” It also gave the plaintiff some leeway because FDA had not filed an opposition to his motion, saying that “at this early stage, the strength of the professional and reputational harm plaintiff asserts rises and falls with the merits of his lawsuit.”

Additionally, the court’s opinion says that it “assumes at this juncture that the investigative report contains allegations of wrongdoing that could lead to plaintiff’s disbarment or some other grave employment-related consequence. For now, then, this factor lends at least some support to granting the motion.”

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

Read more

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