Drugs

Quantitative Framework Could Aid Drug Review: Researchers

UCLA Anderson School of Management researchers say they have developed a quantitative framework that FDA could use to assess candidate drugs based on severity and prevalence as well as characteristics of the drug development process and existing market. “Such a model could augment the complex decision-making and statistical analyses conducted by FDA, providing a more customized approach to policy-making,” the researchers say in their paper.

The researchers note that the tension between providing sick patients with potentially beneficial remedies, while protecting consumers from harmful adverse events, plays a significant role in FDA decision-making. They say they developed a “novel queuing model” of the drug approval process, starting from development through evaluation, FDA approval or rejection, and obsolescence or market expiry. “Our modeling framework can proffer insights for FDA’s approval policy, by permitting flexible approval standards based on differences in disease severity, the number of individuals afflicted with a disease, intensity of research and development, and the number of alternative treatments available for a target condition,” the paper says.

The researchers say their model accounts for three key contributors to the shortfall of therapies available to treat some diseases — low innovation in new drug formulation, lengthy clinical trials, and high rates of attrition in the development process. “Over the years, FDA has introduced a variety of programs designed to address these challenges,” the researchers write. “Our model could help evaluate the impact of these programs on health benefits/costs and monetary gains/losses and, in the case of drugs that qualify for multiple programs, identify which programs offer the largest societal benefit.”

The researchers’ tool is also discussed in this online blog.

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