(CNSNews.com) – Three years since a government audit recommended the Food and Drug Administration (FDA) ramp-up inspections of foreign drug-maker facilities, such inspections rose from 8 percent to only 11 percent, leaving open the potential for harm as dependence on international producers grows, according to a report by the Government Accountability Office (GAO).

The GAO further found that it would take the FDA at least 9 years to inspect all the foreign facilities subject to inspection that make drugs for the United States. The GAO noted that the FDA is required to inspect domestic establishments every 2 years but there is no comparable requirement for inspecting foreign facilities, in a global market where China and India will increase their exports of medical products by 400 percent in the next decade.

The GAO report, released on Sept. 14, is entitled “Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain.”

“Americans once used drugs that were mostly manufactured domestically,” the report states.   “This is no longer the case.”

In fact, the number of drugs manufactured by foreign establishments has more than doubled since 2002, “with China and India accounting for the greatest shares of this growth,” according to the GAO.

According to the report, “Inspections of foreign drug manufacturers are an important element of FDA’s oversight,” and help to ensure that international facilities meet the same requirements as those in the United States – “to ensure the quality, purity, potency, safety, and efficacy of drugs marketed in the United States.”

“But GAO’s prior work showed that FDA conducts relatively few such inspections,” according to the report.

FDA Commissioner Margaret Hamburg visited the Shanghai Institute for Food and Drug Control in August 2010. (AP photo)

In 2007, the FDA inspected 8 percent of foreign establishments subject to inspection.  “At that rate,” the report said, “it would take FDA about 13 years to inspect all such establishments.”

The GAO at that time advised the FDA to increase foreign inspections to a level more compatible with the agency’s domestic checks.

But by 2010, the FDA had increased foreign inspections to only 11 percent, up from 333 inspections to 424, according to the GAO.  At this pace it will take about 9 years, instead of 13, to inspect all foreign manufacturers that supply drugs to the United States, reported the GAO.

The government auditing agency noted the heparin scare in 2008 as an example of the “dangers associated with an insecure supply chain.” The drug is used to prevent blood clots. In the 2008 case, “contaminated heparin, which was associated with numerous adverse events – including deaths – came from a facility in China,” reported the GAO. There were 81 deaths, according to the Wall Street Journal.

Heparin’s raw source material is primarily derived from pig intestines.  “Thousands of small pig farms in Chinese villages extract and process pig intestines in small workshops called casing facilities,” according to the GAO.

A problem for the FDA is gaining access to some foreign facilities, such as the Chinese pig farms.

A shopper walks toward the pharmacy at a Little Rock, Ark., Wal-Mart store. (AP Photo/Danny Johnston)

During the crisis, “Chinese crude heparin consolidators refused to provide FDA full access during inspections -- in particular, one consolidator refused to let FDA inspectors walk through its laboratory and refused FDA access to its records.”

Even if inspectors are allowed into foreign facilities, the FDA contacts the manufactures prior to the inspection, reported the GAO.   Domestically, inspections are conducted without notice to develop a more accurate picture of daily operations.

“In some cases, FDA must obtain permission from the foreign government of the country in which an establishment is located in order to conduct an inspection,” the report states.

The report also noted, “once FDA conducts an inspection of a foreign drug manufacturer, it is unlikely that the agency will inspect it again.”

Not only does the agency face problems gaining access, the FDA does not even maintain a list of foreign drug establishments:  “In 2008, GAO reported that FDA databases contained incorrect information about foreign establishments and did not contain an accurate count of foreign establishments manufacturing drugs for the U.S. market.”

FDA agrees that the agency should conduct more inspections internationally, but acknowledges that it is far from achieving levels of domestic inspections.  In fiscal year 2009, FDA inspected approximately 40 percent of domestic establishments.

“The agency’s ability to close this gap is highly unlikely,” between inspecting the number of foreign and domestic establishments, the report said.

“In light of the growing dependence upon drugs manufactured abroad and the potential for harm, FDA needs to act quickly to implement changes across a range of activities in order to better assure the safety and availability of drugs for the U.S. market,” the report states.

According to the FDA, “China and India are each expected to see a more than 400% increase in their product exports [of medical products] between now and 2020, with China accounting for nearly 20% of all global product exports by that time.”

The GAO credits the agency for implementing some small steps like collaborating with foreign governments.

“However,” the report concludes, “as the agency has acknowledged, there are additional steps that it still needs to take.”