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GAO report leads Harkin to call drug safety inspection system ‘inadequate’


A new report from the Government Accountability Office outlines the safety concerns connected with U.S. government oversight of foreign medications and medicinal components. It’s a situation that U.S. Sen. Tom Harkin, chairman of the Health, Education, Labor and Pensions Committee, says Congress needs to address.

“I think without a doubt that we have a problem with drug safety in this country,” Harkin said Thursday morning by phone. “Forty percent of our finished drugs come from overseas, mostly from China and India, and 80 percent of the ingredients that go into our drugs — both over the counter and prescription drugs — come from overseas. We just have an inadequate inspection system.”

The GAO found inspections of foreign drug manufacturers have improved since its similar 2007 report indicated only 8 percent of foreign establishments were subject to inspection. At the initial rate, the U.S. Food and Drug Administration would need 13 years to inspect all foreign facilities. The FDA’s inspection efforts in fiscal year 2009 represent a 27 percent increase in number of inspections it conducted previously. The GAO also notes that FDA officials understand that they remain far from achieving foreign drug inspection rates comparable to domestic inspection rates.

In addition, current types of inspections by the FDA do not generally include all parts of the drug supply chain, and holding such inspections abroad continues to pose unique challenges — including the authority to require such facilities to undergo FDA inspection.

For example, when tainted Haparin, a blood thinner often used in dialysis treatments, was distributed in the U.S. in 2007, leading to at least 81 deaths and numerous injuries, the problem was traced to a Chinese manufacturing facility that had never been inspected by the FDA. Although Herapin was made by an American company, the active ingredient had been sourced from the Chinese manufacturer, which had relied on other smaller suppliers. The tainted aspect of the drug, according to FDA reports, was likely added in China as a way to cut manufacturing costs.

And, according to FDA estimates, the number of drug products made outside of the U.S. has doubled from 2001 to 2008. In 2010, nearly 20 million shipments of food, drugs and cosmetics arrived at U.S. ports of entry — a decade earlier that number was closer to 6 million. According to the FDA, foreign facilities have grown by 185 percent, while inspection rates have decreased by nearly 57 percent.

In order to combat the existing problem and stem compounding problems that are sure to surface in future years, Harkin says the government needs to revamp old laws governing FDA inspection so that it is better equipped to secure a global supply chain — an effort very similar, he said, as to what Congress passed last year in relation to food safety.

Congressional Hearing

On Wednesday, Harkin and the full HELP Committee held hearings on government oversight of the drug supply chain, gathering testimony from FDA and GAO officials as well as advocacy groups and corporate interests.

Allan Coukell, director of medical programs for the Pew Health Group in Washington, D.C., lamented the fact that no one had yet been held accountable for the earlier incident involving the tainted Herapin.

“This incident represents a clear breach of the security of the U.S. pharmaceutical supply,” he said, adding that Congress has yet to act to update statues that govern drug manufacturing. “Numerous experts have asserted that, absent changes to the system, another such event is inevitable.

“In the case of Herapin, it appears that criminals deliberately introduced a substandard active ingredient into the supply chain. At other times, consumers may be at risk because of failures by manufacturers to comply with quality standards. Poor adherence to quality standards has been observed both in the U.S. and abroad, but the shift of manufacturing to low-cost environments with reduced oversight creates an increased risk. According to one estimate, ignoring Good Manufacturing Practices (GMPs) can save up to 25 percent of a factory’s operating costs. The expectation of inspections is an incentive for compliance with quality standards.”

In 2008, he noted, an Indian manufacturer was cited by the FDA for alleged falsification of stability testing records and use of active ingredients made at unapproved sites, according to a U.S. Department of Justice subpoena motion. And, in 2010, another Indian manufacturer was found to have falsified batch manufacturing records for an anti-platelet medicine. European Union inspectors discovered at least 70 batch-manufacturing records in the plant’s waste yard, all of which had been rewritten, and in some cases original entries changed.

In fact, Coukell added, in 2006, dozens of people in Panama died after taking cough medicine that had been made with diethylene glycol, a sweet-tasting poison solvent. It had been wrongly labeled in China and pass through a series of international brokers, who repeatedly re-labeled it, presumably without performing independent testing. Remarkably enough, it was a diethylene glycol poisoning in the U.S. in 1937 that prompted the government to enact the Federal Food, Drug and Cosmetic Act, which is the document that so many pharmaceutical experts and industry watchdogs now believe needs to be updated to reflect the circumstances of the 21st century.

Kendra Martello, assistant general counsel for Pharmaceutical Research and Manufacturers of America (PhRMA), which represents researched-based pharmaceutical and biotech companies, said her organization favors granting FDA discretion to set routine inspection intervals for foreign and domestic facilities according to risk and in lieu of the agency’s current rolling two-year schedule.

“We support providing FDA with the flexibility to prioritize inspections of foreign establishments based on the risks they present, and believe in relying on set criteria such as compliance history, time since last inspection, and volume and type of products produced, will enhance the FDA’s ability to target its inspection resources efficiently and effectively,” Martello told the lawmakers.

She also suggested that the FDA should recognize and utilize foreign inspection reports or those from accredited third parties to facilitate the often difficult task of oversight of those manufacturers.

“These inspections would not take the place of FDA inspections, which are a necessary and important part of the agency’s mandate; however, they would provide FDA with the flexibility to leverage the work of foreign regulatory bodies and maximize its resources, all without foreclosing its ability to inspect any facility.”

Deregulatory Climate

Amid national discussions on how to spur job creation and enhance the economy, calls for reviewing or eliminating government oversight and regulation of private industry have become common both in Iowa and throughout the nation as part of the 2012 Republican presidential nomination process.

In fact, while U.S. Sen. Mike Enzi, a Wyoming Republican and ranking member of the HELP Committee, noted the need for concessions in U.S. policies regarding the globalization of the pharmaceutical supply chain, he also added a caveat that such increased oversight shouldn’t hinder private industry.

“We want to make sure FDA has the tools it needs to ensure supply chain security,” Enzi said. “At the same time, I am concerned about FDA over-regulating in a way that threatens jobs and patient access to therapies.”

When Congress moves forward to address the problem, Harkin said he will push for strengthened FDA inspection authority for foreign products and facilities.

“We do need legislation and we are working on that. That’s what the hearing was about yesterday. Next year, when we turn to the reauthorization of the Prescription Drug User Fee Act, we’re going to have something in there about FDA’s authority and ability to ramp up inspections of important drugs and components,” he said.

Companies, he said, including pharmaceutical companies, have begun reaching out to lawmakers about increasing foreign inspections and oversight.

“They want this. Why? Because many of them who have sourced their goods in this country have been placed at a competitive disadvantage. They want a level playing field. If we are going to inspect here, then the drugs that come in should also be inspected,” Harkin explained.

“I think this is an area that cries out for some form of regulation and support for a leveling of the playing field. If there are Republicans that say they don’t want to regulate on this are they telling people that this is a just a case of buyer beware? When you give medicine to your kids, you don’t know if it is safe or not? Is that what they want to say?”

The GAO’s statement before the HELP Committee is embedded below:

FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain

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