Drugs

Durbin, Cassidy Introduce Drug Competition Bill

Sens. Dick Durbin (D-IL) and Bill Cassidy (R-LA) have introduced the bipartisan Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act to promote competition by removing FDA barriers to approving lower-cost generic drugs. In a statement, Durbin says the bill responds to some efforts by the pharmaceutical industry to extend monopolies on lifesaving drugs.

“The bill would address a perverse incentive for brand-name drug manufacturers to amass secondary patents to stifle generic competition,” the statement says. “Under current law, whenever a generic drug applicant challenges certain categories of patents covering a brand, that automatically triggers a 30-month stay of FDA approval for the generic, regardless of the circumstances of the case and irrespective of how peripheral the brand’s patents may be to the generic’s application…. The REMEDY Act would remove incentives for drug manufacturers to file additional patents, and would lift barriers that delay generic market entry. Under this policy, generic drug manufacturers would be allowed to enter the market more easily, by having more certainty and visibility into the patent landscape.”

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