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 multiple publications regarding the need for the Food and Drug Administration’s rule on combo drug appeals with expediency.
Following is an excerpt from FDA Week, “FDA Petitioned to Rule on Combo Drug Designation Appeals Within 60 Days,” by David Lim.
Boiani points to the 21st Century Cures Act as an impetus for a new wave of appeals to be submitted to FDA due to Congress’ changes to the combination product framework. He says a review timeframe needs to be place to facilitate implementation of the Cures law.
“FDA inaction will likely thwart implementation of process changes that align with the 21st Century Cures Act’s provisions for determining a product’s primary mode of action. It is a near certainty that these process changes, which go against the historical bias towards designating products for review under an NDA or BLA pathway, will result in some bumps along the way. Allowing the Agency to delay decision-making, and not correct problems it should, will thwart implementation of the new law,” the petition states. …
“You want to have an efficient system for innovation. I understand FDA has a lot going on, but if we are at this stage with my client I expect this will keep happening until a timeline is in place. You want to have your appeals heard in a timely fashion,” Boiani told IHP.
FDA News, “Petition Calls on FDA to Set Timeline for Designation Appeals Process,” by Zack Budryk.
BioWorld, “EBG Petitions FDA to Limit Term of Review of Combo Product Appeals,” by Mark McCarty.