After Heparin: - The Pew Charitable Trusts

500000000
0
—Chapter 2—
Figure 13
FDA-enacted appropriations from fiscal years 2008 to 2011
$4 BILLIONS OF DOLLARS
3.5
3
2.5
2
1.5
1
0.5
0
80
70
60
50
40
30
20
10
0
FY2008 FY2009 FY2010 FY2011
CDER appropriation, including user fees
Source: Appropriations acts for fiscal years 2008, 340 2009, 341 2010 342 and 2011. 343
Total enacted appropriation, including user fees
2.2 Insufficient scrutiny of overseas
manufacturing
2.2.1 Foreign and domestic inspection disparities
One of the FDA’s most important tools for ensuring the safety of drugs sold in the United States is the
inspection of factories to verify compliance with GMP standards. The volume of drugs destined for
the U.S. market makes it impossible to test samples of all products before they reach patients. Checking
manufacturing quality, normally through inspections, is a critical preventive measure to protect the
public from unsafe pharmaceuticals.
The FDCA, written when most drugs were manufactured domestically, requires regular, biennial inspections
only for U.S.-based sites. 344 Although FDA inspectors travel abroad, the FDA’s foreign inspection
service lacks the resources to inspect manufacturing sites with any meaningful regularity (see section
2.3.1). 345 The FDA reported that at least 242 foreign manufacturers of active pharmaceutical ingredients
(API) had shipped product into the United States in 1999 without being inspected by the FDA. 346 As
many as 2,394 overseas plants on the FDA’s inspection planning list have never been inspected by the
agency, according to FDA data analyzed by the U.S. Government Accountability Office (GAO). 347 However,
the FDA does not know with certainty how many of these sites are actively shipping product to the
U.S. market.
Most inspections of foreign sites are pre-approval inspections (PAI), which are a component of a marketing
application approval and are supported by special funding through the Prescription Drug User Fee
46
Pew Health Group