Drugs

Gap Between Drug Approval and Clinical Needs: Study

A study by researchers from Harvard Medical School and other academic institutions in the U.S. and abroad says that there is a widening gap between regulatory approval and the clinical and public health priorities of health systems, payers, and patients after approval of drugs. Writing in an open-source theBMJ article, the authors say that contributing to the issue may be the varying quality of clinical trial evidence available at the time of approval and the resulting uncertainty around the extent of clinical benefits.

The researchers conducted a retrospective cohort study to characterize the therapeutic value of new drugs approved by FDA and the European Medicines Agency (EMA) and the association between those ratings and regulatory approval through expedited programs.

They report that less than one-third of new drugs approved by FDA and EMA were rated by any independent organization as having high therapeutic value. While expedited drugs were more likely than non-expedited drugs to be rated as having high therapeutic value, the researchers say that in absolute terms, most drugs in FDA’s expedited programs were rated as having low therapeutic value, even for breakthrough designated therapies and those that qualified for priority review.

“These data emphasize the importance of robust postmarketing evaluation for expedited drugs,” the article says. “Such an evaluation would confirm early evidence of efficacy and help to elucidate findings from several previous studies suggesting that accelerated approval, priority review, and fast track drugs were associated with increased safety-related reports or labeling changes.”

The authors suggest that policymakers and regulators explore ways to better inform patients and doctors about the results of the rating process and limitations of new drug approvals.

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