Drugs

Study: Minimal FDA Policy Effects on ANDA Prices/Shortages

A new JAMA study shows minimal effects from FDA’s recent policies to expand approvals for generic drugs at risk for price spikes and shortages. “From July 2016 to December 2018, the total number of generic drug applications approved by the FDA increased slightly, but the proportion of approvals for drugs that faced limited competition or had previously been in shortage remained steady,” write the study authors who are from Yale, Johns Hopkins and University of Utah.

There were 1,832 ANDAs approved from 7/2016 to 12/2018 that covered 533 different active ingredients. “There were 133 ANDA approvals in Q3 2016, which initially increased over time before decreasing to 102 ANDA approvals in Q1 2018, but increased again to 262 ANDA approvals in Q4 2018,” the study finds. Of this total, “374 (20.4%) were in limited competition at the time of approval, ranging from 27 drugs (14.2%) in Q3 2017 to 39 drugs (29.3%) in Q3 2016,” it says. “In addition, 717 drugs (39.1%) had experienced a shortage in the previous five years, ranging from 45 drugs (28.1%) in Q4 2016 to 107 drugs (46.1%) in Q4 2017.”

The authors note that the study has limitations, and that only approvals were characterized and not whether companies brought their approved drug to market after approval. Also, they also recognize that ANDAs take time for the manufacturer to prepare and then another six to 12 months for regulatory review. “Nevertheless,” they write, “continued attention is needed to foster approval of generic drugs with limited competition and prior shortage.”

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