The industry Combination Products Coalition generally agrees with the content of FDA's final rule on combination product current good manufacturing practices, but says the rule lacks details on implementation and scope. ...
"It seems as though we're largely in agreement," said Bradley Thompson, an attorney at Epstein Becker Green in Washington, D.C., and chief counsel for the coalition, which represents around 20 different device, drug and biologic firms. "FDA typically seemed to look at our comments and agree with what the interpretation ought to be."
However, he said in an interview, "What they didn't do is say that it was worth editing their rule" to address industry requests for more clarification on various points. "In a sense that's fine, I don't care where the clarification occurs as long as we're all on the same the page and for the most part we see seem to be on the same page."
Thompson says his group is anxiously awaiting the release of a companion guidance document explaining how the rule should be implemented. He says with the release of the rule, he hopes FDA will be more responsive to industry cGMP inquiries. Communication between FDA and industry has been stifled for the past five or six years, he says, because FDA has been in rulemaking mode and couldn't address specific questions on GMP for combo products.
"So now that the rule's final, we're kind of ready to go into overdrive in implementation," Thompson said. "That's why we're really hoping to see a guidance document very soon because we really need our practical questions answered before we can do what FDA wants us to do to implement this rule," Thompson said. ...
Thompson took issue with the fact that the draft guidance did not address changes made to other application types, including 510(k)s or abbreviated new drug applications.
"Basically what we're concerned about is that it really increases the number of submissions for device changes. The reason is very simple: this guidance will treat every device part as though it's a PMA device," he said.
"This guidance tells us to treat every device change as though it's a class III device change. We're very concerned that this up-regulates the device portion of the product and will require many more submissions. No only many more, but of very expensive kind," he added.
His group plans to submit comments on the draft guidance, which are due April 22.