James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Pink Sheet Daily, in “Combo Product Appeals Low in Number, but Lengthy in Decision Time,” by Michael Cipriano. (Read the full version – subscription required.)
Following is an excerpt:
“I think it is a ridiculously long time to decide an appeal, especially when you consider the Agency can decide most appeals in every other area within 30 to 60 days,” James Boiani of Epstein Becker & Green tells the Pink Sheet. “It’s really a consequence of not having a timeline that the agency can be held to.”
Boiani had submitted a citizen petition on behalf of an unnamed client in March calling on FDA to establish timelines for appeals of designation decisions. At the time, the client had an appeal that was under consideration by the agency for a year and a half. (“Combination Product Designations at US FDA Need Faster Appeals Petition Says” “Pink Sheet”) Boiani says the appeal has since been decided, and that he and his client did not get the decision they were hoping for.
He says he is still hoping the citizen petition will encourage to FDA to establish timelines for such decisions.
“We’re considering our options further and deciding whether to appeal to the Commissioner or go to court, but are going to test whether CDER is amenable to a reasonable pathway to approval,” Boiani says.
