The Food and Drug Administration (FDA) Commissioner Margaret Hamburg, speaking before an audience of drug and food company lawyers, issued a warning that those who violate FDA regulations can expect “faster, tougher” action brought against them by the agency.Matthew Perrone, writing for the Associated Press, reports in his article that Hamburg told the audience, ‘"The agency must show industry and consumers that we are on the job . . . Companies must have a realistic expectation that if they are crossing the line, they will be caught."’ This statement comes at a time when the United States Congress is considering new food safety legislation that would expand the FDA’s regulatory authority. The bill, the Food Safety Enhancement Act-HR 2749, has been somewhat controversial for various stakeholders. To read previous Agriculture and Food Law and Policy Blog posts on the bill click here.
Hamburg was confirmed for her position in May. Since that time both the President’s Food Safety Working Group and the Congress has been at work putting together suggestions and legislation focusing on the prevention of food-borne pathogens from the farm to the market. At the Food and Drug Law Institute Conference Hamburg indicated to the audience that they can expect a more aggressive FDA than they may have experienced under previous administrations, “‘I hope that in the future, effective FDA enforcement will not be surprising or out of the ordinary.”’
While the FDA’s primary enforcement mechanism is letters sent to manufacturers, according to Perrone’s article, the number of letters issued by the agency has dropped over the last ten years. Last year the agency issued only 22 letters, a major drop from the 157 letters issued in 1998. The agency did receive a funding increase in the recently passed Senate agriculture appropriations bill.
To read more information on the agriculture appropriations bill click here. To read Perrone’s Associate Press Article click here.
Posted: 08/10/09
