Drugs

Bill Introduced to Add Zika Virus to Priority Vouchers

U.S. Representatives G. K. Butterfield (D-NC) and Susan Brooks (R-IN) have introduced HR 4400, a bipartisan bill that seeks to add Zika virus to the list of diseases included in FDA’s Tropical Disease Priority Review Voucher Program. The voucher program was enacted in 2007 to incentivize the development of treatments, including vaccines and cures, for neglected tropical diseases. Under the program, a company that receives approval for a tropical disease treatment is eligible to receive a voucher that allows the bearer to receive priority review status for any future product.

The Zika virus, which is transmitted by mosquitoes, can infect pregnant women and result in birth defects, including microcephaly and neurological disorders in newborns. The virus also causes skin rashes, conjunctivitis, muscle and joint pain, and headaches in adults. On 2/1, the World Health Organization called Zika a global public health emergency.

“Work is already underway to create a vaccine, but without a priority review voucher in place, a vaccine may not be available for years,” Butterfield said in a release. “We do not have the luxury of time, and I strongly urge my colleagues to join this effort and encourage the rapid development of a vaccine or treatment for this disease.”

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