Food and Drug Attorney Jim Cohen Quoted on FDA Enforcement, Guidance and Information Technology in Washington Lawyer Article

James S. Cohen, a shareholder in the Food and Drug Section of Buchanan Ingersoll & Rooney's Washington, D.C., office, was quoted in the cover story of the February 2010 issue of the Washington Lawyer — the official journal of the District of Columbia Bar. The article, titled "How Safe Is Your Food," examined the safety of food in the United States, and the FDA's new approach to enforcement and regulatory transparency for FDA-regulated products.

In the article, Cohen is among other industry experts, weighing in on FDA enforcement, FDA guidance and FDA information technology in relation to food, as well as drugs, devices and other products.

As noted in the article, "Since President Barack Obama took office, the FDA has touted a new, aggressive policy to ensure food safety. … In October 2009 the FDA warned manufacturers that it would crack down on inaccurate nutritional labeling because of concern that companies are misleading consumers about the health benefits of certain foods. But critics say these efforts are not enough, and that the agency is putting on a new face without any teeth. One of the main problems is figuring out how to deal with manufacturers that deliberately disobey the rules."

The article goes on to note, "Some FDA practitioners are wary of discussions about enforcement tactics, which often focus on more aggressive monitoring and heftier fines, yet potentially neglect extensive outreach efforts."

"The agency needs to be careful that as it ramps up its enforcement actions, it is implementing changes in a fair way that comports with due process," Cohen said. "Most companies just want to know what the rules are so that they can comply. They need as much guidance as possible."

The article went on to address the Obama Administration's commitment to a transparent Government. "As part of this commitment, the FDA formed an internal transparency task force to develop recommendations for making FDA activities and decision making more accessible to the public," stated the article. However, "FDA practitioners say that the agency's internal computer system is outdated, stalling its decision-making process."

Cohen weighed in saying, "There's a problem with internal information-sharing and data collection. It's extremely outdated. How can you make critical and responsible decisions if you can't adequately access information or share it internally?"