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Foreign Manufacturers Legal Accountability Act of 2009: New Import Restrictions in the United States for Medicines Manufactured in Germany?

Prof. Dr. iur. Dr. med. Alexander P. F. Ehlers and Dr. iur. Cord Willhöft

Ehlers, Ehlers & Partner Rechtsanwaltssocietät, München/Berlin

The Foreign Manufacturers Legal Accountability Act of 2009 (hereafter referred to as “FMLA Act 2009”) has been introduced to the Senate of the United States on August 6, 2009. Although the FMLA Act 2009 is currently only at the first step of the legislative procedure, i. e. it has been referred to the Committee of Finance which will revise it before the Act goes into a general debate, it may have, once enacted, a major impact on pharmaceutical manufacturers importing their products into the United States. Therefore, it is recommended to pharmaceutical manufacturers to already take the potential impact of the FMLA Act 2009 on their business into consideration. The scope of the FMLA Act 2009 will be outlined in the following.