The CDER conducted 2,411 inspections of drug manufacturing facilities both in the US and abroad during FY2006, just over 10 per cent fewer than in 2005 (2,682). The number of CDER inspections in the 2002, 2003 and 2004 fiscal years reached 2,585, 2,627 and 2,610 respectively.

The 2006 Enforcement Story issued by the FDA's Office of Regulatory Affairs (ORA) revealed a similar pattern at the Center for Biologics Evaluation and Research (CBER). Domestic and foreign inspections dropped by 5.4 per cent from 1,931 in FY2005 to 1,826 in 2006. In 2002 the CBER conducted a total of 1,985 inspections, a figure that climbed sharply to 2,205 in 2003, then dropped to 2,026 in FY2004.

Product sampling for drugs and biologics showed a less consistent trend. The CDER collected only 340 samples of imported drugs in FY2006, compared with 1,183 in 2005, but sampling of US-manufactured products was up from 1,548 to 2,368 last year. The number of domestic samples collected by the CBER fell from 98 in FY2005 to 24 in 2006, while sampling of imported biologics was almost non-existent in both years.

All the same, the figures are likely to bolster familiar claims that budget cuts and overstretched resources are compromising the FDA's ability to ensure the quality, safety and efficacy of drugs on the US market. These themes were encapsulated last September in a damning report by the US Institute of Medicine, which called for a substantial increase in both funds and personnel at an agency hampered by "lack of clear regulatory authority, chronic underfunding, organisational problems and a scarcity of post-approval data about drugs' risks and benefits".

Criticisms of the FDA's inspection and enforcement policies over the last couple of years have homed in on issues such as perceived laxity in enforcing current good manufacturing practices (cGMPs) at foreign producers of active pharmaceutical ingredients or a sharp fall in the number of warning letters sent out by the agency to drug manufacturers since 2000. This latter trend was ascribed by Henry Waxman, ranking Democrat on the House Government Reform Committee, to business-friendly political influence under the Bush administration.

At the same time, though, the FDA has been trying to make the best of its available resources by introducing a risk-based enforcement strategy that prioritises compliance issues presenting the most serious threat to public health.

There is some evidence of this kind of focus in the 2006 Enforcement Story. The CDER implemented 45 Class I recalls - the most serious kind, where there is a "reasonabled probability that the use of or exposure to a violative product will cause serious adverse health consequences or death - in FY2006, up from just 18 in 2005. Class II recalls, though, were down from 314 to 189 and Class III recalls from 170 to 127. The CDER reported 13 Class I recalls last year, against only one in FY2005, while Class II recalls dropped from 1,848 to 1,377 and Class II recalls from 601 to 451.