ABSTRACT
INTRODUCTION FDA has become quite fond of saying that all regulated products are equally subject to all of the requirements of the FDCA irrespective of their source of origin. This is a true statement, whether the articles are (1) finished drugs or drug ingredients, (2) prescription or over-the-counter (OTC) products, (3) innovator or generic, (4) of any dosage or route of administration, or (5) drugs combined with other categories of products (e.g., drug-device combinations). With this as a first principle, one might reasonably be tempted to anticipate that FDA’s regulatory regime and enforcement schema would reflect substantial international activities to ensure that foreign drug manufacturers comply with drug safety provisions of the Act. However, FDA’s efforts to engage in regulatory oversight of foreign drug manufacturing and distribution have been reduced as a result of budget concerns and the difficulty of performing an audit outside the United States. For the most part FDA has focused its efforts on developing and issuing guidance documents that address requirements unrelated to product safety or quality.
