Drugs

House Commerce Republicans Probe China Trials

House Energy and Commerce Committee Republican leaders have asked FDA commissioner Robert Califf to answer questions about a growing trend for clinical trials to rely solely on enrollment of patients from a single country, particularly China, and the history of fabricated data in clinical trials conducted in China. The Republican inquiry is an offshoot of recent FDA statements about discouraging clinical trials that are conducted in a single country outside of the U.S. because they may not be representative of the U.S. patient population (see earlier story).

Additionally, the Republican leaders have asked the Government Accountability Office (GAO) to conduct a review of FDA’s Bioresearch Monitoring Program (BIMO), which reviews and audits clinical trial sites referenced in applications. “In the past two decades, clinical research has become more global and complex and is increasingly being conducted in countries outside the United States,” the lawmakers say. They are asking GAO to determine:

· How inspections of clinical trial and bioequivalence study sites under the BIMO program help the agency assure the quality and integrity of data submitted to FDA in support of drug applications.

· The frequency of domestic and foreign inspections FDA conducts in support of the BIMO program.

· Any challenges FDA faces in carrying out the BIMO program domestically or overseas.

Click here to read the letter to FDA.

Click here to read the letter to GAO.

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