Tag Archives: Supply Chains

Reed Smith Partner Kevin Madagan to Speak at HDA’s Annual DSCSA Traceability Seminar

Washington D.C. Partner Kevin Madagan of Reed Smith’s Life Science Health Industry group will participate in an exert legal panel discussion at the 2017 Health Care Distribution Alliance (HDA) Traceability Seminar held November 8-10 in Washington D.C. Implementation of the Drug Supply Chain Security Act (DSCSA) continues to transform the pharmaceutical supply chain. As the … Continue Reading

FDA Clarifies Trading Partners Under the DSCSA

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (“DSCSA”). The DSCSA establishes product tracing, licensure, reporting, and other requirements for certain trading partners … Continue Reading

Erroneous Country of Origin Determinations May Result in Significant FCA Penalties for Medical Device Companies

Country of origin labeling issues can be exceedingly complex, as we have noted before. Several manufacturers have recently paid multi-million dollar settlements for alleged misstatements about their products’ country of origin, under the Trade Agreements Act (TAA) and False Claims Act (FCA). As described by Reed Smith attorneys Larry Sher, Larry Block and Jeffrey Orenstein … Continue Reading

A New Focus at FDA: Supply Chain and Import Challenges

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.… Continue Reading
LexBlog