Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in BNA Snapshot, in “FDA Asks for Input on Draft Guidance for Combination Product Manufacturing.”
Following is an excerpt:
Attorney Bradley Merrill Thompson, who represents combination product makers and is with the firm Epstein Becker & Green, told Bloomberg BNA Jan. 26 that the examples in the draft “were in direct response to our begging and pleading for examples. These things are so complex that we really felt until we got to the level of examples there was too much ambiguity.”
Thompson said, “From well before FDA’s publication in January 2013 of its final rule on combination product GMPs, the Combination Products Coalition has been asking for—indeed begging for—the agency to produce a companion guidance document that dives into the details around how the GMPs are to be implemented.” The Combination Products Coalition is an industry group.
“We knew even before the final rule was written that the devil would be in the detail,” he said, adding that after the rule was published in January 2013, “we immediately began pressing FDA to publish the companion guidance document. Sprinkled throughout the preamble to the final rule was an express promise to provide additional detail in guidance. Now, two years after the final rule, it is here. And it is good.”
Thompson said the guidance document “addresses many of the questions that we have been asking. We don’t necessarily like all of the answers, but we deeply appreciate FDA’s publishing the guidance document in which the agency shares its views. Further, we had asked that not only the agency clarify the rules generally, but the agency provide illustrative examples to help make its views more concrete and clear.”