Drugs

FDA Awards Grants to Advance Pediatric Drug Studies

FDA has awarded Advanced Clinical Trials for Children (IACT for Children) and Duke University $1 million each to help advance pediatric clinical trials. The grants are intended to fund research that will “help academia and industry-based institutions overcome some of the historic challenges posed by pediatric clinical trials,” says Office of Pediatric Therapeutics director Susan McCune in an online post. The two groups will “help optimize pediatric study designs, protocols, best practices, and training,” she says.

McCune notes that pediatric research is way behind knowledge gained in trials involving adults. “Despite many efforts over the past two decades to increase the number of FDA-approved therapies for children, some 60% of drugs that are used in children are not approved for pediatric use, and the percentage of FDA-approved options is even smaller for neonates, with 90% of drugs used in this population unapproved for neonatal use.FDA is taking steps to address this problem,” her post says. “These drugs have not been approved for use in children because they have not been successfully tested in pediatric clinical trials. In fact, a recent study found a failure rate of up to 42% for trials that were done under the 2002 Best Pharmaceuticals for Children Act (BPCA), which grants an additional six months of marketing exclusivity for companies that study the drug in children.”

McCune says that it is not clear if pediatric study failures are attributed to drugs not working in this population or if “investigators did not select the right drug, identify the right patient population, choose the right dose, use the right trial design, or identify the right endpoints for their trials.” Additionally, many sponsors are unable to complete their studies because they couldn’t recruit enough subjects to evaluate. To help sponsors, the two grants will support the development and maintenance of a scientific and organizational infrastructure that can plan, start up, conduct, and close out pediatric clinical investigations, she added.

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