Drugs

NIH Xtandi Cost Hearing Sought

Twelve members of Congress are asking the National Institutes of Health (NIH) to use its authority to hold a public hearing on the price being charged by Astellas for its prostate cancer drug Xtandi (enzalutamide) that was developed at UCLA through taxpayer supported research grants from the U.S. Army and NIH. A 3/28 letter to HHS secretary Sylvia Burwell and NIH director Francis Collins says that Astellas is charging U.S. patients $129,000 for the drug, while it sells in Japan and Sweden for $39,000 and in Canada for $30,000. “We do not think that charging U.S. residents more than anyone else in the world meets the obligation to make the invention available to U.S. residents on reasonable terms,” the letter says.

According to the lawmakers, the 1980 Bayh-Dole Act gives federal agencies including the NIH the authority to license a patent “when action is necessary to alleviate health or safety needs which are not reasonably satisfied” or if the invention is not “available to the public on reasonable terms.” They say that price can be a clear barrier to access for consumers, and despite the law being in place for over 35 years, NIH have never used its broad and powerful authority to protect consumers from excessive prescription drug prices.

The letter also says that NIH granted a 2004 hearing on similar issues involving Abbott’s Norvir (ritonavir) that resulted in the company lowering the price for public payors, including AIDS drug assistance programs and Medicaid, and expanding its patient assistance programs.“The NIH has a powerful tool to hold drug companies accountable for barriers to access to drugs developed through support of U.S. taxpayers, including price,” the letter concludes.

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