Drugs

MAPP on SGEs Representing Sponsors Before FDA

CDER has issued a Manual of Policies and Procedures (MAPP) on how it determines whether a current CDER special government employee (SGE) can represent a sponsor before FDA about a specific application. The MAPP says CDER SGEs may, under some circumstances, legally represent sponsors in meetings with FDA. “Although such representational activities may be allowed,” it says, “SGEs must avoid any appearance of a conflict of interest and avoid situations in which it would appear that they are using their government position for private gain.”

The MAPP says current SGEs are prohibited by law from representing a sponsor before FDA if the SGE worked more than 60 days for the government during the immediately preceding period of 365 consecutive days, or if the SGE has ever worked on the specific matter before FDA.

If a current SGE has worked for the government for 60 days or less during the immediately preceding 365 consecutive days, FDA will decide on a case-by-case basis whether it is appropriate for the SGE to represent the sponsor. In making such a determination, the MAPP says, CDER will consider:

the role of the SGE in developing the drug;
the length of time the SGE worked on the specific matter; and
the relationship of the requested representation to the regular duties of the SGE.

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