After Heparin
Protecting Consumers from the Risks of Substandard and Counterfeit Drugs

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.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.^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. 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.  

Read Full Section: Barriers to FDA Oversight(PDF)