A major U.S. heparin wholesaler received a complaint from a corporate customer about a contaminated batch of blood thinner in October 2008, but didn't investigate for almost a year, according to a recent Food and Drug Administration notice to the company.
Scientific Protein Laboratories LLC got the customer complaint months after the FDA announced nationwide recalls of many heparin products. The blood thinner was linked to more than 80 deaths and hundreds of serious reactions in patients in late 2007 and early 2008. In the spring of 2008, an FDA task force said that the cause of the problem was contaminated imported Chinese heparin ingredient.
In a report last month, reviewed by The Wall Street Journal, the FDA told SPL that it "did not adequately investigate a complaint that affected product quality." The report said SPL didn't begin a probe of the contamination complaint until September 2009, and failed to investigate "other lots of heparin that may have been associated with the complaint."
The FDA said Wednesday it cited SPL for "violations of current good manufacturing practice" and is still investigating. "FDA believes the issue does not present a significant public-health risk," it said. An FDA spokeswoman said the batch in question never reached patients.
After SPL looked into the October 2008 complaint, it found that the contaminated raw material was used in two processed batches of heparin , the FDA report said. SPL ended its review of one batch in June 2010. It didn't investigate the second, the FDA said.
SPL, which imported heparin ingredient from its Chinese subsidiary, sold processed batches to one of the nation's largest heparin makers, Baxter International Inc., and to several other companies before the early 2008 recall, according to FDA recall notices.
The heparin scare resulted in numerous lawsuits against SPL and Baxter over injuries and deaths allegedly caused by the contaminated heparin.
A Baxter spokeswoman said SPL didn't inform Baxter about the October 2008 complaint or its handling of the matter because the related batch wasn't sold to Baxter.
SPL said Wednesday the heparin lots in question "passed all the then-required, state-of-the-art testing" to detect contamination, however trace amounts of contaminant, oversulfated chrondroitin sulfate, were found by a customer using their own specialized testing. The company also said no adverse events were reported involving the batch in question.
The companies have said that when they learned of problems, they responded quickly and responsibly, withdrew products from the market and cooperated with the FDA.
The FDA report also said SPL hadn't updated its reviews of two of its suppliers of crude heparin material in the U.S., both brand-name sausage makers. Heparin is derived from animal intestines, mostly from pigs. China has become the major supplier of that starting product.
Republicans on the House Energy and Commerce Committee have criticized the FDA's handling of the heparin crisis. The committee's ranking Republican, Joe Barton of Texas, said: "I've instructed the oversight staff to look into this new report quickly. This is deadly serious business."
The FDA didn't say which SPL customer alerted the company about contamination in October 2008. However, people familiar with the FDA review said the customer was Momenta Pharmaceuticals Inc., a Boston biotechnology company.
Momenta's chief executive, Craig Wheeler, said Wednesday he couldn't comment on communication with the FDA. "What I can say is that we test all of our supplies using our analytics and reject all that do not meet our required quality standards."
In an earlier interview, Mr. Wheeler said Momenta was getting heparin from SPL for a developmental blood thinner with blockbuster potential called M-118.
Momenta has said the company has developed a special method for detecting small amounts of contaminant.
The FDA said Wednesday that a corporate customer's "unofficial testing" found "trace levels" of the contaminant.
On July 23, Momenta and partner Sandoz, a division of Novartis AG, won FDA approval to sell a generic version of a fast-acting heparin. The branded version, called Lovenox, had sales of more than $4 billion in 2009.
