Food and Drug Attorney Jim Cohen Weighs In On FDA's Drug Center in Special Report

James S. Cohen, a shareholder in the Food and Drug Section of Buchanan Ingersoll & Rooney's Washington, D.C., office, was quoted in a January 8, 2010, article published in FDA Week's Special Focus Issue: FDA — The Year Ahead. The article, titled "Drug Center Faces Industry Unrest, Need For Investment In Science," discussed the Food and Drug Administration's Drug Center.

As noted in the article, "In the short term, FDA's drug center appears to be the agency's most stable — it's not likely to be wholly remade this year — but it faces significant long-term challenges and pressure to improve a wide range of scientific capacities amid a continuing focus on post-market safety. Some industry stakeholders are growing frustrated with increases in enforcement that they see as arbitrary and want FDA to articulate new drug safety standards more clearly."

The article went on to note that many believe the most pressing issues for the Center for Drug Evaluation and Research (CDER) in 2010 are "anticipating future shortcomings and responding to trends, rather than crises. … Several industry attorneys said they expect CDER to focus this year on improving its ability to detect and understand drug safety signals, adding that drug makers will press FDA to more fully explain how it interprets those signals."

The article reports that industry stakeholders agree that CDER's recent emphasis on safety, particularly post-market safety, will not abate any time soon, and certainly not in 2010. Stakeholders also agreed that FDA's Commissioner has made good on early promises of increased enforcement. Cohen weighed in saying the agency has yet to supplement its warning letters and other enforcement actions with the direction that industry needs in order to stay compliant. The agency has "jumped into some really aggressive enforcement without adequate notice," Cohen said.

Cohen noted that the industry hasn't yet pushed back against the new enforcement actions in part because of the risk and cost of doing so. But 2010 could easily bring new checks on the way FDA has handled its enforcement role. Cohen explained that pushback doesn't necessarily have to come from drug makers —pressure from Capitol Hill, defeat in the courts, product availability issues or budget constraints could all cause the agency to shift direction.

According to the article, "Industry attorneys also pointed to information technology and data-analysis systems as a top priority for CDER. But the systems are so intricate and layered, sources said, that it's hard to see major upgrades happening quickly."

"It's just so big that I don't know when we're going to see change," Cohen said.