Wednesday, November 3, 2010

GAO: FDA Fails to Inspect Foreign Drug Plants Sufficiently

US General Accountability Office writes a scathing report on the FDA’s failure to inspect foreign drug manufacturing facilities.

Ed Silverman in Pharmalot blogs about the US General Accountability Office recent report which has determined that the FDA failed to implement earlier recommendations that would close the gap between the agency’s approach to inspecting domestic and foreign drug manufacturing facilities.

According to the Pharmalot post:

• The GAO writes that it is unclear if steps being taken by FDA “will prove successful” and there is an “urgent need” to better protect public health by putting GAO suggestions into practice.

• Here are some key findings:

o The FDA boosted its budget for foreign inspections to $41 million in fiscal 2009 compared with $12 million in fiscal 2008 and $10 million in fiscal 2007, and increased the number of foreign inspections.
o In fiscal year 2009, for instance, the FDA conducted 424 foreign inspections, compared to 333 and 324 inspections conducted in fiscal years 2007 and 2008, respectively.

• The GAO examined a list the agency kept to prioritize foreign inspections and estimated only 11 percent of the facilities were completed in fiscal year 2009.

• “At this rate, GAO estimated it would take FDA about 9 years to inspect all establishments on this list once.” That same year, 1,015 domestic inspections were made, or about 40 percent of domestic facilities.

• The FDA did not know how many foreign drug establishments were subject to inspection, because of inaccurate info in agency database. There were 3,765 facilities in the FDA databases, but 2,394 may never had been inspected. Most of these, not surprisingly, are located in China and India.

• The FDA continues to emphasize inspections of establishments listed on applications for a new drug, instead of those already producing drugs for US consumption. The FDA’s approach is “inconsistent” with the GAO’s 2008 recommendation that the FDA inspect plants, “at a comparable frequency,” that are identified as posing the greatest public health, regardless whether these are foreign or domestic, if there is a manufacturing problem.

• The US Department of Health and Human Services acknowledged the need for improvement, but cites obstacles toward progress, such as the need to obtain permission from the foreign government of the country in which an establishment is located in order to conduct an inspection.

Clearly this report is very troubling to the average health care consumer given the proliferation of raw material contamination's, recalls due to poor manufacturing process, adulteration, fraud and a myriad of other issues that plague our pharmaceutical supply chain.

Historically pharmaceutical companies are outsourcing more of their raw materials, production and packaging than ever before and the FDA does not have the capacity or ability to identify all of the manufacturing plants are that produce the drugs that are taken every day by US consumers.

Along with more robust inspections, it is incumbent upon all members of the supply chain to take measures to make absolutely certain that the products of their brand or the products they distribute or dispense are safe and efficacious.

Secure Pharma Chain encourages all members of the pharmaceutical supply chain to implement a variety of solutions and technologies to test and authenticate the products within their inventories to protect their brand and most importantly the consumer.

To read the entire Phamalot post, visit:

To learn more about pharmaceutical verification technologies, visit:

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