USA's GAO slams FDA for failure to implement 2008 recommendations

The USA’s Government Accountability Office last week publicly released its September 2010 Report to the House Committee on Oversight and Government Reform concerning Drug Safety, titled “DRUG SAFETY - FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed.

The latest in GAO’s “High-Risk Series” of reports, it sharply criticizes the Food and Drug Administration for persistent shortcomings in its oversight and inspection of foreign drug establishments - functions essential in the GAO’s view to “safeguarding the nation’s drug supply in today’s global marketplace,” writes Jennifer Davis of US law firm Hyman, Phelps & McNamara on its FDA Law Blog.

The report details the findings of a GAO performance audit initiated in November 2009 at the House Committee’s request to evaluate the FDA’s progress in: (1) conducting more foreign drug inspections; and (2) strengthening the data it uses to oversee and manage the foreign drug establishment inspection program. Both recommendations were included in two previous GAO reports issued in 1998 and 2008. The latest, September 2010 report faults the FDA for failing to implement the GAO’s prior, specific recommendations and for otherwise failing effectively to address the “long-standing challenges” in its foreign drug inspection program, which, the GAO emphasizes, “are not new, as [its] prior work shows.” The report concludes that “it is urgent that FDA implement GAO’s prior recommendations to better protect public health,” says Ms Davis.