Heparin Drama Underscores Need for More FDA Funding and Supplier Oversight

April brought painful reminders of the human cost of pharmaceutical quality control problems, the need for more FDA resources and better supplier risk management. It also highlighted the tenuous relationship that the Agency and its leaders already have with many U.S. lawmakers.

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At last count, 11 countries were estimated to have distributed heparin contaminated by hypersulfated chondroitin sulfate (HCS), a cartilage derivative which was found in several batches manufactured by Scientific Protein Laboratories LLC (SPL)’s Chinese subsidiary, Changzhou SPL and distributed by Baxter Healthcare. So far, 81 people who suffered adverse reactions from the substance have died.

Some of their relatives testified before the U.S. House of Representatives’ Energy and Commerce Committee’s oversight panel on April 22. Perhaps most poignant was Leroy Hubley of Ohio, who lost both his wife, Bonnie and his son, Randy, within a few weeks after they were injected with the unsafe heparin during dialysis.  “Now I am left to deal not only with the pain of losing my wife and son, but anger that an unsafe drug was permitted to be sold in this country,” he stated at the hearing.

Baxter officials suspect that the chemical was added deliberately.  China experts vehemently disagree, noting that SPL needed to oversee its distributors much more closely.

At a press conference in early May reported on by the Xinhua Chinese News Agency, Jin Shaohong, deputy director of China’s National Institute for the Control of Pharmaceutical and Biological Products, said that there was no way to confirm a direct causal relationship between the HCS and the clinical causes of death.  He noted that Covidien Pharmaceutical Co. and B. Braun Pharmaceutical Co. had bought raw heparin from SPL without any ill effects.

The Chinese plant is run according to quality standards established at U.S. headquarters and by directors assigned by the parent company, Xinhua reported. 
Jin also accused Baxter of impeding investigations of the root cause of the problem, saying that Baxter did not provide either production records or samples, according to Xinhua.

Baxter officials dispute this statement, Reuters reported, and say they cooperated fully with China’s investigation, while an FDA spokesperson said the Agency had not received any requests for information from Chinese authorities.
U.S. lawmakers blamed both Baxter and its contract manufacturer for lax oversight and quality standards.  “Both Baxter and SPL have failed the American public,” said Bart Stupak, chairman of the House of Representatives Energy and Commerce Committee’s oversight and investigations panel.

But they also criticized FDA, whose commissioner Andrew von Eschenbach was questioned by representatives for two hours. Rep. John Dingell was most scornful of efforts made so far.  “You are the Commissioner of the FDA, and you are presiding over an intolerable situation,” he said, banging on a nearby table for emphasis. “You have one fine scandal going on and a number of others in [food related areas].

He suggested that the Commissioner was showing himself incapable of addressing his responsibility to protect the U.S. public.  “This committee wants you to have the sources you need to do the job you need to do to protect the U.S. public.”
Dr. Von Eschenbach responded that a systemic overhaul was needed, and gave the cost in China as $135 million —$45,000 per inspection, times 3,000 facilities, just for drugs.

Reuters reported that Dr. Janet Woodcock, head of FDA’s CDER, said the Agency needed Congress’ help to ensure that similar tragedies do not recur, noting that it would cost $225 million per year for FDA to inspect all drug manufacturers around the world that supply pharmaceuticals to the U.S.

U.S. Congress is reportedly considering legislation to charge industry fees to pay for more of these inspections.

 

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