FDA Hires New Directors, Deputy Directors for Four Foreign Offices
Posted 14 September 2015 | By
A big shakeup is underway at the US Food and Drug Administration's (FDA) foreign offices as four new directors and one deputy director were named to the agency's posts in China, Europe, India and Latin America.
The shift to new leadership comes as the following employees have moved on: Christopher Hickey, Ph.D., (former director, China Office), Carl Sciacchitano (former acting director, India Office), Michael Rogers (former director, Latin America Office), and Bruce Ross (former deputy director, Latin America Office), FDA announced in a blog post.
Replacing them will be:
FDA also highlighted some of its recent work in its foreign offices. For instance, in China, FDA signed two deals in late 2014 to expand FDA's in-country investigators to increase the number of inspections of firms that manufacture FDA-regulated products.
In addition, FDA highlighted its Mutual Reliance Initiative (MRI) with EU regulators, under which FDA accompanied EU officials on audits of pharma manufacturers in three EU countries. The FDA's Europe office also managed an EU audit of FDA’s oversight of Active Pharmaceutical Ingredient (API) manufacturers in the US. That led to the EU relying on FDA oversight of APIs in the US and allowing American-made APIs into the EU market.
The highlights come as a recent report by the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) claims FDA has made substantial improvements to its inspections of foreign generic pharmaceutical manufacturers.