Drugs

Physician Group Can’t Sue FDA Over Drug OK

A 9^th Circuit Court of Appeals three-judge panel has ruled that Physicians for Integrity in Medical Research has no standing to sue FDA over the agency’s decision not to revoke its approval of the chronic obstructive pulmonary disease drug roflumilast (AstraZeneca’s Daliresp). In its 2011 suit, the group said the drug does not work well and frequently causes side effects, Courthouse News Service reports. A lower federal court had dismissed the suit, ruling that the group lacked standing to sue, and the appeals court agreed.

The complaint included a statement from a doctor who said that failure to revoke the drug’s approval will cause him to lose patients and that he will not be compensated for the time it takes him to explain to patients his beliefs about the drug. Even assuming that the doctor suffered injuries, the appeals court said, they arose from decisions his patients made and not from any action FDA took.

Physicians for Integrity in Medical Research says it hopes to persuade the full group of 9^th Circuit judges to hear the case.

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