Drugs

Harvard Reseachers Ask: Why No Generics?

Harvard Medical School researchers say policymakers should examine 25 high-cost drugs they studied to determine why generic or biosimilar versions are not yet on the market and how to take steps to facilitate entry for the benefit of patients and to reduce unnecessary Medicare spending. Writing online in the Journal of General Internal Medicine, the researchers say they looked at the novelty of active ingredients in the 25 branded drugs with the highest Medicare Part D spending in 2017.

Among the 27 active ingredients identified, 11 (41%) had previously been approved by FDA in other formulations or products. “Many active ingredients in the 25 brand-name drugs with the highest Medicare spending were discovered decades ago, with a substantial minority having been previously marketed in alternative formulations or products,” the researchers say. “Repurposing already approved drugs in new formulations, drug/device combinations, or for new indications is a less costly form of drug innovation, because preclinical work and early-phase clinical trials may be streamlined, and is also less risky for sponsors. High Medicare spending on such older products is facilitated by patents on new delivery devices or formulations, which can protect against entry of low-cost generic versions.”

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