FDA’s New Chief Of Staff Suggested Greater Authority On Nano-Supplements
This article was originally published in The Tan Sheet
Executive Summary
FDA’s new chief of staff has recommended pre-market registration and testing of products with nanoparticles and post-market reviews of nano-engineered supplement ingredients.
FDA Commissioner Margaret Hamburg taps as her chief of staff Lisa Barclay, an advocate of greater agency oversight of nutritional supplements containing nanoparticles.
Barclay currently is a partner at Zuckerman Spaeder, where she co-authored a 2009 report
on FDA regulation of nanotechnology-based dietary supplements.
Supplement manufacturers should be required to report non-serious adverse events associated with supplements containing nanoparticles in addition to the current requirement for reporting serious AEs linked to supplement products, the report argued (Also see "Nanotech Growth Means Shrinking Window For Enacting Effective Regulation" - Pink Sheet, 19 Jan, 2009.).
The authors also recommended FDA receive authority to equire pre-market registration and testing of products with nanoparticles and to undertake post-market reviews of the safety of nano-engineered supplement ingredients.
Barclay co-wrote the report with William Schultz, who now is acting general counsel at the Department of Health and Human Services.
Barclay is no stranger to the Office of Commissioner, where she worked on policy issues from 1995 to 2001.
While at Zuckerman Spaeder, Barclay's focus was on complex civil litigation, professional responsibility, legal ethics and food and drug law.
Perhaps most notably, she worked on a case in which the firm represented Roxane Laboratories during GlaxoSmithKline's attempt to prevent the approval of generic versions of Flonase (fluticasone furoate) nasal allergy spray (Also see "GSK Drops Suit Against FDA Approval Of Generic Flonase" - Pink Sheet, 7 Mar, 2006.).
FDA's organization has been in a state of flux under Hamburg. She most recently created a new layer of management between medical product center directors and the commissioner's office (Also see "FDA Becomes An Agency Of “Directorates” Under Hamburg’s Reorganization" - Pink Sheet, 18 Jul, 2011.).
Under previous Commissioner Andrew von Eschenbach, the chief of staff served as the major point of contact between the centers and the commissioner (Also see "FDA Re-Org Makes Chief Of Staff Liaison Between Centers, Commissioner" - Pink Sheet, 3 Sep, 2007.).
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