Drugs

Drug Makers Should Do More Postapproval Studies: Researchers

A new study published online in JAMA finds that pharmaceutical companies often conducted clinical trials after winning FDA approval, but most were not related to the approved use unless directed by the agency in a postmarketing requirement or commitment at initial approval. The study, conducted by researchers at Tufts School of Medicine, University of Connecticut, and University of California (San Francisco) School of Medicine, says that when postapproval trials are not required or voluntarily conducted, “patients and clinicians are left to rely solely on the pivotal trials that supported FDA approval to inform treatment and prescribing decisions.”

The JAMA study says that most therapeutics approved had at least one postapproval trial generating new safety or efficacy evidence, and only 12% of the trials were exclusively for the first FDA-approved indication. “Instead, most trials investigated new indications or expanded patient populations,” it says.

To ensure that patients and physicians have access to the highest-quality clinical evidence on approved indications, FDA could require “more postmarketing requirements both at approval and during the market lives of therapeutics as new clinical questions arise,” the researchers write. “The FDA may also communicate evolving clinical and regulatory priorities to pharmaceutical companies, facilitating the development of postmarketing commitments. These efforts may become increasingly critical as expedited approval pathways continue to be used, resulting in more therapeutics reaching the market with limited evidence. If pharmaceutical companies do not voluntarily conduct postapproval trials that address persistent gaps in clinical knowledge on approved therapeutics, greater reliance on postmarketing requirements and commitments may be needed.”

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