This post was written by Frederick H. Branding, R.Ph., JD and Kevin M. Madagan.
Numerous signals by the Food and Drug Administration (“FDA”) in recent weeks, including statements made by Dr. Margaret A. Hamburg, the recently appointed FDA Commissioner, show 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.
This article discusses two areas in which FDA has begun to focus – supply chains and imports, in particular supply chain management and safety, and increased foreign and domestic import inspections. Included in the discussion are suggestions companies may wish to consider in preparing for increased regulatory scrutiny.
To read the full alert, click here.