Food and Drug Attorney Jim Cohen Quoted on FDA's Long-Awaited Proposed Rule on Good Manufacturing Practices for Combination Products

James S. Cohen, a shareholder in the Food and Drug Section of Buchanan Ingersoll & Rooney's Washington, D.C., office, was quoted in a September 28, 2009, article published by The Gray Sheet. The article, titled "Proposed Rule Defines Good Manufacturing Practices For Combo Products," reported on the U.S. Food and Drug Administration's long-awaited proposed rule on good manufacturing practices for combination products, which was released September 22.

As explained in the article, "The draft regulation, about four years in the making, is intended to help firms comply with necessary parts of device, drug and biologics manufacturing regulations."

However, as noted, industry representatives, such as Cohen, believe that "until companion guidance is developed, a number of nitty-gritty questions will remain unanswered."

"In particular, it is unclear which FDA center will oversee compliance by the maker of a particular combination product, and how FDA will integrate principles of the proposed rule into its manufacturing facility inspections, says regulatory law expert and former FDA official Jim Cohen," stated the article.

The article went onto discuss how the proposed regulation elaborates on a 2004 draft guidance,  which some say helps answer some of the questions raised, but not all.

According to Cohen, an area that needs to be addressed includes the oversight procedures. "Within headquarters, between CDER, CBER and CDRH, who is going to be responsible for the compliance oversight of the product, and how are they going to talk to each other? What kind of guidance will be given to field investigators?"

These sorts of issues will not be clear even when the final rule is published, Cohen said. "They have to do a draft guidance as soon as they can when they issue the rule."