Drugs

FDA Promoting Generic Drug Competition

FDA says it is taking the first two steps under the agency’s Drug Competition Action Plan to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. An agency news release says the actions involve publishing a list of off-patent, off-exclusivity branded drugs without approved generics, and implementing a new policy to expedite the review of generic drug applications for products on the list.

“FDA will continue to refine and update the list periodically to ensure continued transparency around drug categories where increased competition has the potential to provide significant benefit to patients,” the release says.

To improve the review process, the agency says it will expedite its review of generic drug applications until there are three approved generics for a given drug product.

The release also restates the scheduling of a 7/18 public meeting to solicit input on ways that FDA rules, including the standards and procedures related to generic drug approvals, “are being used in ways that may create obstacles to generic access instead of ensuring the vigorous competition Congress intended.”

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