Drugs

Hemophilia Patient Group Asks for Hemlibra Hearing

Patients for Access to Advanced Hemophilia Therapy is asking FDA to hold a public hearing to examine the effects on the nation’s medical system of “commerce-driven, court-ordered, drug access restrictions.” In its 4/8 petition, the group says it is concerned that Baxalta/Shire, as part of a Delaware federal court suit over intellectual property, has asked the court to deny some patients access to Genentech’s Hemlibra (emicizumab-kxwh)‎, which the group describes as a “promising hemophilia therapy.”

“Restriction of access based on issues unrelated to medical therapy is a threat to FDA’s drug evaluation system, a threat to the reward system that enables progress, and a threat to patients who, like ourselves, need better therapies,” the petition says.

The petition says an FDA hearing should focus on these issues:

how commerce-driven court-ordered restrictions on drug access would affect the delivery of medical care;
the impact of such restrictions on drug development and patient access to new therapies; and
whether legislation or rulemaking is needed to prevent such restrictions.

The group says it has no opinion on the validity of the Shire claim of patent infringement in the marketing of Hemlibra and simply wants to assure that the issue of patent ownership does not affect access to this potentially breakthrough hemophilia A therapy.

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