Baxter Didn’t Know Heparin Plant Wasn’t Inspected
6 CommentsBy Ed Silverman // February 21st, 2008 // 1:02 pm
That’s because the drugmaker doesn’t monitor its supply chain to the extent that it would know a supplier in China was never inspected before it began shipment of its Heparin blood thinner, Baxter’s ceo tells The Chicago Tribune.
Baxter, which stopped making Heparin last week after it was linked to 350 illnesses and four deaths, contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company’s Chinese affiliate. And so “it’s not unusual for us not to know that the FDA hasn’t inspected a supplier to a supplier,” Baxter ceo Bob Parkinson tells the paper. The FDA, meanwhile, says its inspectors began looking at the plant in China on Wednesday.
Scientific Protein Laboratories makes the active ingredient for the drug at a plant in Changzhou, China. The FDA explained earlier this week that the plant, which Scientific Protein co-owns with a Chinese joint-venture partner, never was inspected because its name was confused in registration materials with a different company that had been inspected.
Parkinson says that Baxter’s auditors had inspected the facility in the last six months, but he declined to speculate on whether they may have missed something. “It is both premature and inappropriate to go down that path,” he maintains. [Our thought: Poor choice of words, Bob. That is an appropriate question to ask].
Joseph Acker, president of the Synthetic Organic Chemical Manufacturers Association, a trade group, says the onus for quality control falls on Baxter and other firms that rely on China for pharmaceutical material. “We have to be sure that the standards that we set in this country are upheld,” he tells the Trib. “If that’s not certain, then you just don’t buy material from China until they can demonstrate that they can meet our standards.”
Patrick Soon-Shiong, ceo of American Pharmaceutical Products, which is a competing Heparin supplier, tells the paper that his company was involved in establishing procedures and “quality control” to monitor their China suppliers. “The best way to ensure the highest quality of raw material is to have feet on the ground in China who are American-trained and who understand the high level of good manufacturing guidelines with the FDA,” Soon-Shiong tells the paper.
Baxter first became aware of trouble with heparin in November, when several isolated cases in Missouri quickly led to a flurry of reports about adverse reactions, some of them serious. Baxter’s market surveillance soon identified nine lots of suspect product, and the company in January recalled those nine lots. Parkinson said a top priority for him is returning heparin to the market.
“It’s a small product for the industry, but it’s significant in terms of its importance to clinical care,” Parkinson says. “We have as a company an obligation to the medical and the patient community to get the product available.”
fear 'n loafing
Baxter steadfastly refuses to accept responsibility for their own product… quoting the lead-in from the Tribune’s article… “Baxter International Inc. does not monitor its supply chain to the extent that it would know that a supplier in China was never inspected before it began shipment of the blood-thinning drug heparin”.
Is there not something troubling about that statement… If it were YOUR product, wouldn’t you want to know that the facilities where your product and its intermediates will be produced, passed inspection? Wouldn’t your quality assurance staff be all over your contractors and suppliers, ensuring proper regulatory control/manufacturing operations???
And having said that… do we even know the root cause of the illnesses and deaths…? Inspection doesn’t guarantee a safe product. Done properly, it can provide assurance that manufacturing systems systematically controlled… but it doesn’t confer patient safety.
What we see here is that Baxter is clueless. They don’t know their contractors, they have offered little insight into what went wrong (if anything), and they have taken little responsibility for the affected patients, beyond a delinquent product recall.
ol cranky
Aren’t CMC people and GMP QA/QC people supposed to conduct routine inspections of these facilities to ensure they have no surprises if there’s an audit by a regulatory agency? Sheesh!
dhouze
Pulease! Even for excipients, manufacturing site change notifications are mandatory. No buts about it. If SPL didn’t notify Baxter and FDA they are in deep doo doo. If they don’t have stability data for product manufactured from materials aquired from the new site they are in deep doo doo. Whoever owns the NDA for this product is in deep doo doo.
Bob Freeman
One would think the local Baxter subsidiary or affiate in China would have had some degree of responsibility. Then again, the local office may not have a manufacturing ops person, but one would think the regulatory head would have been responsible. Or, this is a corporate responsibility for which the local affiliate would have had no oversight.
Bingo
According to the FDA website, Baxter’s NDA was originally approved in 1972. My guess is that they were on autopilot here.
While the snafu withthe inspection IS a big deal, I am unaware of any concrete evidence to indicate the problem stems directly from the API. There are plenty of other potential causes for this sort of thing. Baxter, of course, bears the responsibility for the problem whatever it is. It is very easy in the current climate to shout about lousy manufacturing practices in China and I think Baxter is perfectly happy to blame “a supplier to a supplier.” The problem is that Baxter is responsible for the product that goes out the door and ultimately into the consumer. It’s important not to conflate the issues of FDA inspection and oversight, Chinese cGMP, and Baxter’s faulty product.
Viral Pharm
Could this be related to contamination of the pig intestine used for the preparation by Clenbuterol Hydrochloride?
See: “Clenbuterol (4-amino-(t-butylamino)methyl)-3,5-dichloro benzylalcohol hydrochloride), belonging to the family of β–agonists, is currently used as bronchodilators for the treatment of asthma in humans, as well as tocolytic agents in veterinary medicine. However, clenbuterol has been used illegally at higher dosages (ten to hundred times the clinically active dose) to promote animal growth in muscular mass, and at the same time decreasing fat accumulation. Although these properties were known in 1984, the use of clenbuterol did not become widespread until 1988 in response to the European directive forbidding the use of hormones in animal production. Even so, no standard was established for clenbuterol, or other β-adrenergic agonists, for such purposes. On the contrary, clenbuterol and similar products were included in the list of substances formally banned for zootechnical use.”
“Outbreak of illness concerning clenbuterol was reported at Hong Kong in 1997. Limits to the tissue content of clenbuterol residue in meat products have been established by law in China. However, it is difficult for Chinese government to control the illegal use of clenbuterol in swine production because there are too many individual farmers and small farmers are breeding swine in China. “
From: http://www.healthyeatingclub.com/APJCN/Volume16/vol16suppl.1/WeihuaLai(106-110).pdf