Eli Tomar Quoted by STAT News on Drug Compounding Court Ruling
Eli Tomar, counsel in the health practice at Akin Gump, has been quoted in the STAT news article “The FDA can finally implement that big compounding law … nearly six years later.” The article reports on a lawsuit over compounding rules in which the Food and Drug Administration recently prevailed.
The dispute centered around whether a compounder can make a product using bulk powder. The article says the ruling gives the FDA legal authority to move forward with its own policy—a victory for drug makers that have been battling compounding pharmacies.
According to Tomar, who represents compounders that work with FDA-approved drugs rather than bulk drug substances, “It is likely that the agency will significantly speed up its clinical need evaluations over the coming weeks and months.”
To learn more about the court ruling, click here for an Akin Gump client alert that Tomar co-authored.