In China, when an executive of a major company is found to have a manufacturing problem that results in consumer deaths, the executive may turn to suicide. That’s not the case here in the U.S. where executives regularly flaunt health and safety regulations to the detriment of the public. Regulators at the U.S. Food and Drug Administration have generally been the passive tail being wagged by the corporate dog, but there seems to be a groundswell within the agency to change the way it does business.
High profile recalls are prompting the change, along with new leadership that has vowed it will not be business as usual and criminal charges may be in order.
CNN reports FDA Commissioner Margaret Hamburg wrote to Sen. Chuck Grassley, R-Iowa, in March to say that the agency intends to consider “the appropriate use of misdemeanor prosecutions, a valuable enforcement tool, to hold responsible corporate officials accountable.”
For example, the recent series of pharmaceutical recalls of Tylenol and children’s cold and allergy over-the-counter medications, made by McNeil, a subsidiary of Johnson & Johnson, may be the first to fall under the ax.
The FDA would pursue criminal convictions for violations of the federal Food, Drug and Cosmetic Act against executives who knew or should have known about manufacturing problems that threaten public safety.
In the case of J & J, the children’s Tylenol plant in Pennsylvania was found to have multiple violations including bacterial contamination, an open roof, and inconsistent formulations. The plant is still closed. Many children reportedly were sickened.
The problem has been the “get government off our backs” attitude of industry and a compliant federal leadership. With corporations setting their own rules, FDA enforcement and inspections dropped. CNN reports there were 600 criminal prosecutions against companies in 1939. By 1989 that number had dropped to 16.
Things seem to be changing. In 2009, there were more than 1,742 drug recalls and 684 food recalls in 2010. Food recalls also come under the umbrella of the FDA.
The message is clear to industry – clean up your act or you could go to jail. A felony conviction could result in a $10,000 fine and up to three years in prison.
Since the FDA is funded by our tax dollars and it in charge of protecting the public, shouldn’t we have insisted on this all along?
