FDA/CBP Held Second Import "Blitz" on Unapproved Foreign Drugs Imported Via Courier Hubs, Mail Facilities

According to the press release, this "blitz" found 1,728 unapproved drugs, including so-called "foreign versions" of FDA-approved drugs, recalled drugs, drugs requiring special storage conditions, drugs requiring close physician monitoring, and drugs containing addictive controlled substances.

(FDA and CBP conducted their first import "blitz" on mail shipments of foreign drugs to U.S. consumers in Summer 2003 at the Miami, New York (JFK), San Francisco and Carson, CA mail facilities. See ITT's Online Archives or 10/02/03 news, 03100220, for BP summary on the first FDA/CBP blitz.)

Second "Blitz" Targeted Express Courier Hubs and Mail Facilities

According to the FDA, the second series of "blitz" examinations were performed in November 2003 at the Buffalo, Dallas, Chicago, and Seattle U.S. Postal Service (USPS) mail facilities and the Memphis and Cincinnati express courier hubs.

The FDA notes that this second blitz marked the first time that imported drugs entering the U.S. through express courier hubs were targeted in addition to those that pass through USPS mail facilities.

Majority of Examined Parcels Were Exported from Canada

FDA and CBP inspectors examined a total of 1,982 parcels that appeared to contain drug products. The majority of the products found in the examined parcels were drugs, but also contained other types of FDA-regulated products, such as dietary supplements and foods, as well as products not regulated by the FDA such as pens and notepads.

According to the FDA, parcels were examined irrespective of the country from which they were being exported, but Canadian parcels appeared more frequently than parcels from any other country. Of the 1,006 parcels that entered through mail facilities, FDA states that it determined that approximately 80% of the parcels were exported from Canada, approximately 16% from Mexico, and the remaining 4% were exported from Japan, the Netherlands, Taiwan, Thailand, and the United Kingdom.

The FDA states that the 1,728 unapproved drug products found during its second "blitz" included (a) improperly labeled drugs, (b) controlled substances, (c) potentially recalled drugs, (d) so-called "foreign versions" of FDA approved drugs, (e) drugs requiring risk management and/or restricted distribution programs, (f) drugs requiring careful dosing, (g) drugs with clinically significant drug-drug interactions, (h) biologic drugs which should be administered by a healthcare provider and are not licensed by FDA, and (i) investigational products.

FDA Will Continue to Cooperate with CBP in Conducting More "Blitz" Exams

The press release also states that in general, FDA and CBP do not have sufficient resources to perform comprehensive examinations of the huge number of parcels brought to the U.S. by mail and commercial couriers. Instead, the FDA intends to continue to cooperate with CBP in conducting more "blitz" exams of individual drug imports. To this end, FDA states that it will endeavor to:

use its limited investigatory and regulatory resources more strategically to focus on the foreign sources of illegal, unsafe imported drugs;

work with commercial shippers and credit institutions to identify shipping patterns of known vendors of unsafe drugs so that it can more accurately target their shipments and sources;

form partnerships with other federal, state, and international regulatory and law enforcement agencies to combat these illegal imports; and

educate the public about the dangers of illegally imported drugs.

FDA press release (P04-07, dated 01/27/04) available at www.fda.gov/bbs/topics/NEWS/2004/NEW01011.html.