The House Energy and Commerce Committee is opening an investigation into the heparin crisis, in which contaminated batches of the blood thinner from China were linked to more than 100 American deaths in 2007-2008. The committee, which has trained its eye on heparin and global drug safety in the past, has asked the FDA for help identifying and pursuing those responsible for the contaminant.
According to the Wall Street Journal, the lawmakers wrote that those responsible for the adulterated heparin “pose a continuing threat to pharmaceutical products imported to the U.S." Just last week, an FDA official involved in the ongoing heparin investigation said that the agency found contaminated batches of heparin from China as far back as 2000 and 2001.
Speaking at the American Association for the Advancement of Science meeting last week, Center for Drug Evaluation and Research official Ali Al-Hakim suggested that those involved in substituting oversulfated chondroitin sulfate, the toxic raw material found in the contaminated Chinese heparin, were likely highly educated, as the formulation of the false ingredients was finely calibrated to pass assays. He also said that updates to the U.S. Pharmacopeia and new “end-testing” requirements mean that heparin coming into the U.S. today is much safer than that in the batches that sickened patients.
According to FDANews, Al-Hakim told the audience “FDA has also moved into inspecting more of the ‘crude’ phase of production in China,” something he indicated is a daunting undertaking. Sending one inspector for one week to countries such as China or India costs $20,000 to $25,000.” And at current rates of inspection, some Chinese and foreign plants producing materials for drugs in the U.S. may never be inspected, according to a Pew Prescription Project fact sheet on the safety of the U.S. drug supply.
When inspections do occur, FDA inspectors have sometimes been denied entry, Al-Hakim said, and with such infrequent visits, it’s hard to establish that observed conditions are continuous ones. “But we need their drugs. That is a problem.” Current estimates suggest that 80 percent of the U.S. supply of heparin originates in China. In fact, estimates suggest 80 percent of active or bulk ingredients in prescription drugs that make their way to U.S. medicine cabinets originate overseas.
"The number of drug products made at non-U.S. sites has doubled in the past decade. The FDA's ability to ensure the quality at these sites has not," Pew's Allan Coukell told the Journal.
Recent bills introduced in Congress would provide more resources for amping up inspections, establish systems to streamline data on a drug’s origin and manufacture path, and increase industry’s accountability for all ingredients in the supply chain. As we’ve discussed here recently, the FDA has been very vocal about the need to better protect the safety of the global drug supply, and is exploring both legislative and internationally cooperative solutions. The recent findings in the heparin investigation remind us that the stakes remain high.
--Kate Petersen, PostScript blogger