Drugs

Balance Drug Approval Flexibility, Evidence: Study

Two Harvard University researchers who compared regulator treatment of first-in-class drugs in the U.S. and Europe say regulators need to carefully balance flexibilities with rigorous assessments of evidence for the drugs. Writing in Health Affairs, the researchers say they investigated FDA approval data for 186 first-in-class drugs from 2013 to 2023 and data for 121 drugs approved by both FDA and the European Medicines Agency (EMA) in the same period.

The study focused on review durations, expedited program use, and characteristics of pivotal efficacy trials, the authors write.

They say they found that the pivotal trials leading to approval frequently demonstrated the flexibility of regulators in the permitted design elements. They also found that FDA regulatory review durations varied by therapeutic area.

“FDA treatment of first-in-class drugs showed greater use of expedited regulatory pathways with only slightly shorter review durations,” the authors say. “The substantial regulatory flexibility applied to first-in-class drug approvals can help ensure that such drugs reach the market as quickly as possible, but it also raises the stakes for postapproval oversight of the drugs to ensure that they continue to have the expected effectiveness and safety in routine clinical use.”

The study says that while many U.S. initiatives and regulatory guidelines accelerate access to innovative drugs for unmet medical needs by providing flexible pathways for their development and approval, the societal benefit remains controversial, as accelerating access to new but clinically uncertain drugs may compromise the safe use of drugs, effective regulation, and the equitable distribution of public health resources. “Our findings underscore the need for regulators to carefully balance regulatory incentives with rigorous ongoing assessments of evidence supporting drug innovations,” the authors conclude.

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