HP&M Comments on IND Guidance; Says FDA Lacks Authority to Impose Requirements on Non-drug Studies

April 8, 2014

By Jennifer M. Thomas & James P. Ellison

Hyman, Phelps & McNamara, P.C. (HP&M) filed comments on April 7 concerning FDA’s Guidance document, Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND (the “Guidance”).  HP&M has previously blogged on this Guidance (here, here, here, and here).

HP&M’s comments on the Guidance focus on the legal issues that the Guidance raises.  Most important, through the Guidance FDA seeks to impose on food, medical food, dietary supplement and cosmetics the same pre-study requirements that the law properly authorizes for drug studies.  However, FDA has no legal authority to impose these requirements on non-drug studies, as HP&M’s comments make clear.  The negative public health impacts of FDA’s unauthorized Guidance, while not the primary focus of these comments, would be profound.  HP&M’s comments point out that the only appropriate solution is for FDA to remove references to foods and cosmetics from the Guidance and to revise the Guidance to make it consistent with the authority granted to FDA under the Federal Food, Drug, and Cosmetic Act.