It seems as though one cannot watch or read the news without learning of the recall of another FDA-regulated product. From eggs contaminated with salmonella to deli meats bearing listeria, to the litany of products, including over-the-counter drugs and medical devices like contact lenses and hip implants, it appears as though the FDA's capacity to safeguard the country's food and drug supply is at an all time low. The number of recalled products has skyrocketed, with nearly 1000 food and drug products recalled already in 2010.
The FDA, aware of its weak public perception, is actively investigating again using its criminal prosecutory authority aggressively under the Park Doctrine. Stemming from the Supreme Court's decision in United States v. Park, 421 U.S. 658 (1975), the Park Doctrine allows the FDA to seek misdemeanor convictions of executives of entities found to have violated the Federal Food, Drug, and Cosmetic Act if the executives possessed the authority to stop or prevent the violations and failed to act. The executives may be convicted even if they were not aware of the violations.
While the Park Doctrine was applied widely at one time, it fell out of favor in the 1980s, and by the early 1990s most FDA prosecutions were reserved for cases of fraud rather than manufacturing violations. Speaking at the 2010 Food and Drug Law Institute Annual Conference, the FDA's deputy chief counsel for litigation, Eric Blumberg, stated that he expects to see the first of many prosecutions of corporate executives, and in a letter to Sen. Charles Grassley (R-Iowa), Commissioner Margaret Hamburg wrote that the FDA will be considering misdemeanor prosecutions as an enforcement tool for corporate accountability.