Drugs

Regulatory Review Lags Yield Fewer Drugs in Development

University researchers in the U.S. and Turkey say that, on average, three additional months of FDA regulatory review delay result in one fewer drug in development in that drug category. Writing in Health Economics the researchers say, “Our results suggest that the length of the regulatory review delay matters for pharmaceutical firms’ research and development decisions and that the firms are likely unable to pass on these costs to consumers.”

The researchers say that while many people believe that the central trade-off facing FDA involves balancing assurances that drugs are safe and effective with bringing treatments to the public as quickly as possible, this statement misses dynamic effects of the regulations such that if agency review takes longer, fewer treatments will be developed in the future.

According to the study, the reduction in new drugs in development due to delayed regulatory review does not constitute a policy recommendation without consideration of the other costs and benefits of the FDA review. But, it says, the results show that the time it takes FDA to review new drug applications should be an issue considered in policy debates.

“All else equal,” the authors conclude, “our finding that the drug loss stemming from lengthy reviews is substantial suggests that FDA should consider further ways to accelerate the review process.”

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