FDA Policy/General

Number of FDA Port of Entry Agents Up

FDA has told the House Energy and Commerce Committee that the number of Office of Criminal Investigations (OCI) special agents assigned to Port of Entry (POE) duty doubled in August from six to 12. In addition, OCI added an import senior operations manager to oversee the program, and also added four part-time POE special agents. The agency statistics were provided in response to an Energy and Commerce 6/8 letter expressing concern that FDA may not be appropriately devoting resources to prioritize efforts to combat the opioid epidemic.

The agency letter says that as a result of additional support in the FY 18 Omnibus budget bill, OCI will add 10 additional full-time POE special agent positions, pending a nationwide government-wide recruitment. An additional 10 part-time POE special agents also have been added, it says.

“Once fully staffed,” FDA says, “the POE program will consist of 22 full-time special agents, 10 part-time special agents, and two senior operations managers.”

The letter says the priority for the POE special agents is to respond to relevant issues at the international male facilities, ports, and express mail hubs, and to work collaboratively with Customs and Border Protection and other law enforcement agencies to stop the flow of illicit medical products, tobacco, and food into the U.S.

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