Drugs

House Leaders Raise Heparin Shortage Concerns with FDA

Four House committee leaders overseeing FDA 2/2 wrote commissioner Scott Gottlieb expressing concern over the risk of worsening U.S. shortages of heparin due to new supply pressures in China, currently the source of 60% of the crude ingredients used to manufacture heparin here. In an extensively researched 13-page letter, Energy and Committee chairman Greg Walden (R-OR), vice chairman Joe Barton (R-TX), Health Subcommittee chairman Michael Burgess (R-TX) and Oversight and Investigations chairman Gregg Harper (R-MS) cited large discrepancies in China-reported import-export data for heparin since Chinese companies acquired two top U.S. producers in 2013.

Their areas of concern, the congressmen wrote, “relate to the following: (1) whether the Chinese heparin supply is in fact shrinking or increasing, which could affect the risks of a heparin shortage in the U.S. and could raise the risk of economically-motivated adulteration; (2) whether Chinese customs data accurately reflect Chinese export and import activity; and (3) whether the recent emergence of significant U.S. heparin [exports] to China is further constraining the U.S. domestic supply of heparin.” Since 2013, they noted, commercial data show that Chinese heparin exports to Thailand had increased ninefold, making that country the leading heparin export market, with a similar leap in exports to Hong Kong. Meanwhile, official Chinese customs data showed variously both a modest increase and a decline in the same period.

Although heparin was recently added to FDA’s drug shortages list, the four congressmen asked Gottlieb to produce by 3/2 a contingency response plan in the event of a heparin 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