James S. Cohen, a shareholder in the Food and Drug Section of Buchanan Ingersoll & Rooney's Washington, D.C., office, was recently quoted on the U.S. Food and Drug Administration's (FDA) proposed rule on combination product good manufacturing practice requirements. The proposed rule — published by the FDA on Wednesday, September 23 — was the focus of the recent Regulatory Affairs Professionals Society conference, held on September 16, and attended by the largest concentrated group of regulatory professionals, including Cohen.

Information discussed at the conference was reported on by a number of sources, including the September 18 edition of FDA Week and the September 21 edition of The Gray Sheet.

As noted in the FDA Week article, titled "Industry Seeks Clarification in FDA's Combo Products Rule," "Industry lawyers this week urged FDA to clearly lay out in its upcoming proposed rule on combination product good manufacturing practices whether all provisions from the drug GMPs or the device Quality System Regulation must be adhered to, and whether the agency will allow alternatives to the GMPs."

Cohen was quoted in the article explaining that the "FDA has said the proposed rule will clarify, specify and codify the GMP requirements, ensure 'consistency and appropriateness' and provide a framework for designing and implementing a GMP system."

Prior to joining Buchanan, Cohen spent more than 17 years in senior legal, program and policy positions with the FDA. During his tenure there, he led the agency's development of the Proposed Rule on Current Good Manufacturing Practice for Combination Products.

The FDA Week article went on to report that among the key questions, according to Cohen, are "how will FDA describe the legal framework for the GMP regulation of the constituent parts and the finished combination products. … at what point in the manufacturing process do constituent parts become part of the combination product. … Companies want to know [which] provisions from the drug GMPs or the device QSR must be incorporated into their primary regulatory systems. … There are also industry questions [of] whether FDA will allow for alternatives to the GMPs, he said."

According to the article, other key issues noted by Cohen include "how will blood GMPs, tissue regulations and biological standards be incorporated into combination GMPs, how will manufacturer and manufacturing sites be defined and how will cross-labeled products be addressed."

The article further reported that  "Industry wants to know how FDA can ensure that its inspections and compliance/enforcement activities are 'consistent and appropriate' during the proposed rule [period]. In other words, industry wants to know what will the training be for FDA investigators and compliance officers in the absence of a Compliance Policy Guide, Cohen said.  Industry questions how FDA will ensure that center review, safety and compliance offices share information with each other, given that FDA's computer infrastructure is not updated. Finally, industry wants to know what types of compliance actions FDA has taken for combination products, Cohen said."

In The Gray Sheet article, titled "Combination Product Rules Clear OMB, To Be Released In Weeks," Cohen stressed the importance of the rule, saying, "It's a major step."