Drugs

Grassley Probing Orphan Drug Program ‘Misuses’

Sen. Chuck Grassley (R-IA) says he is gathering information on possible misuses of the orphan drug program and how that might affect drug prices. “Based on the reporting from Kaiser Health News about how the orphan drug provisions appear to be stretched beyond their original intent, and the strong consumer concern about high drug prices, I’m interested in learning whether the unanticipated uses of the provisions are contributing to high prices for commonly used drugs,” he said in an email statement to FDA Webview. “My staff is meeting with interested groups and other Senate staff to get their views on the extent of the problem and how we might fix it. I also continue to work on other ways to help bring down drug prices, such as increasing competition with available products.”

Grassley’s inquiry comes on the heels of FDA’s 2/9 approval of Marathon Pharmaceuticals’ orphan drug Emflaza (deflazacort) tablets and oral suspension to treat patients age five and older with Duchenne muscular dystrophy (see story). The company and the agency are feeling some backlash over the $89,000 annual price tag Marathon says it will charge for a decades-old steroidal drug, which is 50-70 times higher than the drug’s price overseas.

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