Drugs

Congressman Wants Insulin Omission Info from FDA

Rep. Mike Kelly (R-PA), a diabetic and member of the Congressional Diabetes Caucus, is asking FDA for information on issues that may have contributed to it not listing insulin as a peptide drug product eligible for generic production in ANDA guidance issued 10/2017. In a 7/16 letter to FDA acting commissioner Ned Sharpless, Kelly says one reason for the steady rise in the cost of insulin is “because the regulatory pathway for generic insulin production is currently inhibited for reasons I would like to know and address.”

The letter asks for detailed responses to two questions:

why FDA did not include insulin in the 10/2017 ANDA guidance for certain peptide drug products and whether there are safety, efficacy, or statutory barriers to its inclusion; and
if there were statutory limitations preventing insulin’s inclusion, what legislative action is needed to remove the obstacles.

In a news release, Kelly says that if FDA had included insulin in its peptide drug ANDA guidance, “it could have opened the door to the domestic production of generic insulin, resulting in unprecedented competition in the insulin market, making it more accessible and affordable for all Americans.”

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