GAO Says FDA Needs to do More to Address “Economic Adulteration”

By Kurt R. Karst –      

Last week, the Government Accountability Office (“GAO”) released a report, titled “Food and Drug Administration: Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health,” in which the GAO examines FDA’s approaches to detecting and preventing so-called “economic adulteration” of food and medical products, and the challenges FDA faces in detecting and preventing such adulteration.  The report responds to requests from Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ), and John Dingell (D-MI) that the GAO review how FDA oversees the safety of products to prevent and respond to economic adulteration.  The requests followed two high-profile cases of economic adulteration involving melamine and melamine-related compounds in pet foods and oversulfated chondroitin sulfate in the blood thinner heparin – in both cases, the products were imported from China.

Economic adulteration (also known as “economically motivated adulteration”) is defined in the report to mean “the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.”  Economic adulteration includes, for example, “dilution of products with increased quantities of an already-present substance (e.g., increasing inactive ingredients of a drug with a resulting reduction in strength of the finished product, or watering down of juice) to the extent that such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances in order to mask dilution.”  (The definition of “economic adulteration” used in the GAO report is the same definition FDA proposed in April 2009 as a working definition for “economically motivated adulteration” – see 74 Fed. Reg. 15,498 (Apr. 6, 2009).)  Economic adulteration, a form of “intentional adulteration” whose primary purpose is financial gain, differs from other types of adulteration – both intentional adulteration, whose primary purpose is to cause harm (e.g., bioterrorism or sabotage), and “unintentional adulteration” (e.g., adulteration for failure to follow good manufacturing practices) – says GAO in the report.  The FDC Act does not make a distinction between intentional and unintentional adulteration, but rather prohibits the introduction of adulterated food, drugs, and medical devices into interstate commerce.  Similarly, “FDA primarily approaches economic adulteration as part of its broader efforts to combat adulteration in general, such as efforts to ensure the safety of imported products.”

FDA officials and stakeholders GAO interviewed in preparing the report noted several key challenges to detecting and preventing economic adulteration, including increased globalization, an increase in supply chain complexity, and difficulties with gathering information from industry (due to concerns about sharing proprietary information).  To enhance FDA’s efforts to combat economic adulteration, GAO recommends that Commissioner Hamburg take three actions: (1) officially adopt a working definition of “economic adulteration,” because “[w]ithout such a definition, when FDA detects adulteration, it is more difficult for the agency to make a distinction between economic adulteration and other forms of adulteration to guide the agency’s thinking about how to be more proactive about this issue;” (2) “provide written guidance to agency centers and offices on the means of addressing economic adulteration;” and (3) “enhance communication and coordination of agency efforts on economic adulteration,” because “[w]ithout such communication and coordination, in these times of economic uncertainty, FDA may not be making the best use of its scarce resources.”

FDA notes in the Agency’s response to the GAO report that FDA recently established the Working Group on Economically Motivated Adulteration (“WEMA”), which is comprised of staff from all FDA centers, the Office of Regulatory Affairs, and Office of the Commissioner.  WEMA, which held its first meeting on September 23, 2011, and will use the Agency’s proposed working definition of economically motivated adulteration to identify topics of broad Agency interest, “seeks to encourage information sharing across FDA on issues relevant to economically motivated adulteration.”