Reed Smith Client Alerts

Authors: Kevin M. Madagan

Type: Client Alerts

Dr. Margaret A. Hamburg, the recently appointed Commissioner of the Food and Drug Administration (“FDA”), made an important statement during her first round of interviews since becoming Commissioner: “Under my new leadership, the industry can expect to see a more aggressive posture with respect to enforcement.” This remark follows numerous signals by FDA over the past few weeks that the agency intends to toughen enforcement in several areas. These signals should be taken seriously. An “awakened” FDA will be funded with additional monies promised for FDA’s budget and with funding proposed through legislation such as The Drug and Device Accountability Act of 2009 (S. 882). As a result, firms that manufacture, import, and distribute FDA-regulated products can anticipate being visited more often, and probably more critically, than in the past. This, in turn, will force a company to handle additional Inspectional Observations (FDA 483s), Warning Letters, and reinforcement actions.

Discussed in the attached .PDF are two areas – supply chains and imports – in which FDA has begun to focus. Included in the discussion are suggestions firms may wish to consider in preparing for increased regulatory scrutiny.

Download the .PDF to learn more!