James R. Johnson
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Foreign inspections have long been part of FDA's efforts in ensuring medical product safety and quality. In fact, FDA has
been conducting foreign inspections for the past 50 years. It is through such foreign inspections that the agency monitors
the manufacture of pharmaceutical products and ingredients that are imported into the United States. The primary goal of the
inspections is to ensure that foreign establishments meet the same requirements as domestic establishments in regards to the
quality, purity, potency, safety, and efficacy of pharmaceutical products marketed in the US. If a foreign pharmaceutical
manufacturing establishment fails to meet FDA's cGMP standards—based on an inspection or otherwise—the agency has the legal
authority to deny products manufactured at the violative facility entry into the US.
FDA officials acknowledge that the agency is far from achieving foreign drug inspection rates comparable to domestic inspection
rates. Each year, however, FDA investigators are appearing more frequently at the doors of foreign manufacturing facilities.
For example, between 2007 and 2009, FDA inspections at foreign pharmaceutical manufacturing establishments increased by 27%.
The agency seems to have no intention of slowing down—FDA has created a dedicated cadre of foreign drug investigators and
established permanent offices in Europe, China, India, Central and South America, South Africa, and the Middle East.
The US government's increasing focus on foreign inspections should come as no surprise. Pharmaceutical manufacturing has become
more global, and the US market has, in turn, become more reliant on foreign medical products. Based on FDA's estimation:
- 40% of finished drugs, 80% of APIs, and 50% of all medical devices are currently imported.
- There was a 13% increase in pharmaceutical products imported into the US between 2002 and 2009.
- From 2000 to 2007, the importation of "high-risk" medical products, such as vaccines, quadrupled.
- In 2002, there were just over 500 FDA registered foreign drug-manufacturing establishments. That number grew to more than
3000 in 2007, and registered foreign establishments now outnumber registered US establishments.
- In 2000, the US imported roughly $1.7 billion more in biopharmaceutical and pharmaceutical products than it exported; by 2008,
that gap grew to $18 billion.
Because of the dramatic increase in the volume of imported drug products and the increasing complexity of the global supply
chain, FDA is operating as an internationally-focused consumer safety agency. In doing so, the agency is pressing forward
with increased foreign inspections, as well as partnering with foreign counterparts to create global coalitions of regulators
focused on ensuring and improving global product safety. A clear result of which has been the significant increase in Warning
Letters and Untitled Letters issued for international drug quality issues—in 2005, three such letters were issued; in 2010,
FDA issued 23.
As FDA's focus on foreign pharmaceutical manufacturing increases, it is critical that non-US facilities be prepared for an
FDA inspection more than ever, particularly those establishments that have no—or limited—experience in dealing with FDA. Therefore,
if your facility manufactures abroad for the US market, it is important to keep the following guiding principles in mind when
preparing for an FDA inspection.
