Drugs

FDA Pushed to Release Company Application Data

With Canada and the European Union releasing much of the data companies submit when seeking approval for a new drug, biologic, or medical device, pressure is being placed on FDA to change its stance that says that such information contains confidential trade secrets and can’t be released. National Public Radio reports that transparency advocates say that clinical study reports need to be made public to understand how regulators make decisions and to independently assess a drug or medical device’s safety and efficacy. They also say the reports give medical societies more thorough data to establish guidelines for a treatment’s use, and to determine whether articles about clinical trials published in medical journals are accurate.

An FDA spokesperson told NPR that FDA does not have as much freedom as Canadian and European regulators to release clinical study reports. However, the report says that some legal experts contend that FDA has more flexibility than it acknowledges.

NPR says FDA has flirted in the past with releasing clinical study reports to the public. A 1/2018 pilot program was to post portions of reports for up to nine recently approved drugs if the drug companies would agree. So far, only Janssen has volunteered, and its prostate cancer drug Erleada is the only entry in the database. In June, the agency said it was considering changing its focus from the pilot program to an effort designed to better communicate the analyses of FDA experts who review drug applications. But critics say such analyses are no substitute for the actual clinical study reports.

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