Drugs

CRS Wants Guidance Against ‘Draize’ Tests

Saying that drug manufacturers too often are ignoring informal FDA communications stating that the agency does not require submission of in vivo rabbit ocular and skin irritation tests (Draize), the Center for Responsible Science (CRS) is asking the agency to issue guidance “communicating broadly that FDA will accept in vitro primary skin and eye irritation data” and that Draize tests are no longer recommended. The CRS petition says that the agency, industry, and CRS share a goal of achieving more efficient drug development, and that FDA can help achieve the goal by clearly communicating to industry through guidance documents when a discrepancy exists.

FDA is aware of the confusion about skin and eye irritation testing, CRS says, but has not developed broad guidance due to a lack of resources. The petition includes draft guidance language developed by CRS.

“Although FDA has stated that Draize test data are not required for primary skin and eye irritation testing,” the petition says, “drug sponsors continue to provide Draize test data. Often, drug sponsors provide Draize data because they believe FDA requires it, despite promising data from other skin and eye irritation methods. As early as 2005, FDA stated Draize data are not required for primary skin and eye irritation. However, of the 137 new molecular entities approved by FDA between the years 2011-2014, 24% were tested for skin and 22% for eye irritancy, and of these, the Draize test was used in 94% of all skin irritation and 60% of all eye irritation tests. Additionally, of these drugs for which the Draize test was conducted, 76% were for systemic, not topical, administration, and thus no irritancy testing of any type was necessary. Unless FDA issues guidance for industry to address this discrepancy, drug developers will not have adequate assurance that FDA does not require Draize data.”

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

Read more

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