Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in FDA Week, in “FDA Clarifies Rules for Drug Containers, Delivery Systems in Draft Guide,” by David Hood.
Following is an excerpt:
Bradley Merrill Thompson, an attorney for Epstein Becker & Green who serves as general counsel for the mHealth Regulatory Coalition, said manufacturers requested companion guidance when the final rule was issued two years ago. Since then, they have been confused, wading through the complicated rule.
“The last two years has been a struggle, because we had this rule and we had the preamble to the rule,” said Thompson. “And there were some companies that were struggling to figure this out. And there were some at FDA that were not all that sympathetic.”
Thompson said the biggest omission by FDA was what to do with legacy products, or products that have already been on the market for some time. FDA did not specify in the document whether the rule would apply to combination products retroactively. In a perfect world, said Thompson, FDA would grandfather combination products into the system and exempt them because of their legacy status. But FDA and industry, he said, are at an “impasse” on the legacy issue. He said FDA is not conceding any ground on the issue and does not seem to be interested in engaging with stakeholders.