After Heparin: - The Pew Charitable Trusts

CHAPTER2
BARRIERS TO FDA OVERSIGHT
2.1 Overview
The FDA is responsible for protecting the public health by ensuring the safety and efficacy of human and
veterinary drugs, vaccines and other biological products, medical devices, the U.S. food supply, cosmetics,
dietary supplements and products that emit radiation. 327
The precarious state of FDA resourcing and capacity is broadly recognized. The regulatory demands
placed on the agency far exceed its ability to respond, according to a 2007 FDA advisory committee
report that outlined serious scientific shortcomings within the agency. 328 Between 1988 and 2007, Congress
passed 123 new laws requiring FDA action, but according to the report, the agency was allocated
only a 9 percent staffing increase through appropriations. 329 The FDA’s Principal Deputy Commissioner
from 2009 to 2010, Dr. Joshua Sharfstein, testified at a Congressional hearing in March 2010 that the
agency does not have the resources and authority it needs to ensure the safety of imported drugs and
components, and is not currently able to prevent another tragedy like the heparin adulteration (see case
study 1). 330
The FDA has received some important augmentations to its budget in recent years. Total enacted appropriations,
including user fees, were $2.63 billion, $3.25 billion and $3.67 billion for fiscal years 2009,
2010 and 2011, respectively (see figure 13). 331–334 The agency also received a supplemental appropriation
of $150 million in June 2008 to support regulatory activities in response to globalization, in particular
food supply safety programs. 335,336 Funding allocations for the FDA’s Center for Drug Evaluation and
Research (CDER) and related field activities in the Office of Regulatory Affairs (the office that conducts
inspections, among other functions) have also increased, although at a slightly lower rate than overall
appropriations. With these funds, FDA has begun to address issues such as understaffing and information
technology (IT) capacity, but as outlined in this chapter, serious capacity and structural problems
remain, and they weaken the agency’s ability to regulate drug manufacturing and importation.
The FDA inspects foreign plants that make drugs and ingredients for the United States at much lower
rates than it inspects domestic sites. 337 IT systems for tracking drug manufacturing sites are archaic and
contain data-entry errors. 338,339 An estimated 20 million shipments of FDA-regulated goods entered the
United States in 2010; however, border assessments are hampered by data systems that contain errors
and do not permit effective risk-based targeting (see section 2.3.3). Oversight is also undermined by the
FDA’s lack of enforcement tools and needed authority, such as the power to mandate a recall or to subpoena
documents for investigations.
After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 45