Drugs

FDA Cites Clinical Investigator Lapses

An 8/15-9/14/16 FDA inspection at a clinical trial site operated by Cassandra Curtis, Indianapolis, IN, found that she failed to follow legal and regulatory requirements governing the conduct of clinical investigations in a Chantix (varenicline tartrate) trial conducted for Pfizer. A just-released 1/27 Warning Letter says the inspection was part of the agency’s Bioresearch Monitoring Program that evaluates the conduct of FDA-regulated research to ensure that the data are scientifically valid and accurate, and to help ensure that the rights, safety, and welfare of the study human subjects are protected.

Specific issues noted on an FDA-483 included:

failing to ensure that the investigation was conducted according to the investigational plan;
failing to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation; and
failing to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.

The agency letter expresses concern that Curtis’ response to the observations primarily involved action taken by American Health Network (AHN) and not corrective actions that she personally has taken. Although Curtis notified AHN that does not intend to serve as principal investigator for any future studies at AHN and will continue to serve as principal investigator only for her current open registry study, FDA said she did not provide details on how she plans to prevent similar violations in any future studies she may conduct at sites other than AHN.

“Your failure to maintain adequate and accurate drug accountability records, including documents recording drug return, raises significant concerns about the adequacy of your oversight and control of [an] investigational drug, which could impact the validity and integrity of data at your site,” the letter says.

Curtis was told to respond with a list of actions taken to prevent similar violations in the future.

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