FDA Policy/General

Former FDA Policy Head Lands at Akin Gump

Former FDA deputy commissioner for policy, legislation, and international affairs Anna Abram has joined Akin Gump as a senior advisor in its public law and policy practice. After almost four years at FDA, Abram left her role as FDA’s top policy official in January.

While at FDA, Abram led high-profile initiatives on drug competition, drug compounding, agricultural biotechnology, food policy, medical countermeasures and tobacco policy. In addition, she led the establishment of the Office of Global Policy and Strategy.

Previously served for eight years on the Senate Health, Education, Labor and Pensions (HELP) Committee and as health policy director and senior advisor to senator Richard Burr (R-NC), the ranking member on the HELP Committee. Prior to that, she served in the White House as an associate director at the domestic policy council, working on health care policy issues under president George W. Bush.

Abram received her bachelor’s degree from the University of Pennsylvania.

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