Andy: FDA Responded To Heparin With ‘Alacrity’
4 CommentsBy Ed Silverman // February 15th, 2008 // 6:03 pm
In his weekly note to FDA employees this afternoon, FDA Commish Andy von Eschenbach writes agency staffers with an update on the Heparin affair - you know, the Baxter blood thinner linked to 350 side effects and four deaths. The active ingredient is made in a plant in China, which the FDA never inspected. Given the barrage of criticism aimed at the agency, Andy tries to lift everyone’s spirits and assure them that he is ‘championing’ their cause. This was penned, by the way, just one day after Congressman Bart Stupak called for him to resign.
From: Commissioner’s Comments
To: FDA-Wide
Sent: Fri Feb 15 16:25:02 2008
Subject: COMMISSIONER’S COMMENTS: The Challenge of Protecting Patients and Consumers
Early this week, our agency announced that Baxter Healthcare Corporation had temporarily stopped manufacturing multiple-dose vials of heparin, a blood-thinning drug administered each year to millions of American patients. The reason for Baxter’s decision - and for FDA’s statement to physicians urging extreme care in the use of heparin - was evidence of severe adverse reactions. As of today FDA and the company, which imports heparin’s active ingredient from China, still don’t know the cause of the incident, but are intensively investigating it in the US and abroad.
For me, the incident provides a telling example of the multiple stresses and challenges that confront our agency in the increasingly complex, increasingly inter-dependent world of global trade. Ensuring the safety of drugs, which in their vast majority include imported ingredients, is among our most resource-intensive new challenges. We’ve addressed this problem in part by beginning to monitor drug performance on a life-cycle basis, and by visiting China and India to lay the foundation of a novel system that would help ensure the manufacturing quality and clinical safety of regulated products before they’re exported to the US.
But in the meantime we’re facing a multitude of tough realities: a highly complex drug supply chain involving thousands of overseas companies; a labor-intensive and expensive inspection program; an incompletely developed IT infrastructure; and a huge workload outside the pharmaceutical arena that also makes urgent demands on our limited resources.
Confronted with these facts, our agency has responded to the reports of heparin-associated adverse events with its customary alacrity and sound judgment. For the team of FDA’s experts who were charged with this task, the simplest solution - recalling all of Baxter’s heparin - was not an option: the firm manufactures one-half of the doses administered to patients before certain types of surgeries and kidney dialysis. The action we therefore recommended, and Baxter accepted, was our public warning to physicians, dialysis center staff and health care providers advising them to use alternate heparin sources or, if they are unavailable, to follow several specific steps.
I want to express my appreciation to all of the FDA employees in the field and at headquarters who contributed their knowledge and expertise to this difficult but carefully calibrated decision that’s typical of the many we make day-in and day-out. Our work on heparin illustrates FDA’s teamwork at its best: managing a complex public health issue and doing what’s right for patients. I cannot be the inspector in a pharmaceutical facility, and I don’t analyze the epidemiological data. I can, however, champion our agency’s cause, and you can be sure that I am working with Congress and the administration to bring FDA’s resources more closely in line with the agency’s workload, its challenges, and the demand of Americans for effective protection for their health.
Andy
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
Matt
I am not too sure how complex, challenging, or stessful it is for the FDA to inspect the manufacturing plant in China or their products at the border when they enter the United States; seems like an easy process, but one that the FDA didn’t bother to implement.
B. Martin, MD
The current implication by the media is that the severe reactions to Baxter’s bolused heparin are related to the fact that the company’s heparin supplier, Scientific Protein, receives some of its raw material from its Chinese plant. However, we simply don’t know the link to be causal yet. Scientific Protein Labs also processes some of its heparin in its Wisconsin facility.
Further, the contention that policing the global manufacture and world trade of pharmaceuticals and their raw materials is somehow “easy” (especially for an already overextended agency like the FDA) defies the experience of anyone whose held a position of responsibility.
Ed Silverman
Hi B. Martin,
Thanks for the note. If you read the post above the von Eschenbach e-mail to FDA staffers, you’ll see that, yes, it’s not clear what if any link there is between the Chinese plant and the medication. I’ve tried to reiterate that in the few posts I’ve run on this subject.
Meanwhile, you may be interested to read the interview with the Rutgers Business School professor about this subject. You can access that post by glancing to the right on the main Pharmalot page and looking for featured posts. It’s entitled ‘Message to Pharma - Get Out of China, Now.’
Thanks for stopping by,
ed
B. Martin, MD
Ed,
You are probably already aware, but some interesting information is buried deep in today’s WSJ article on the continuing investigation re Baxter’s heparin (graf 6):
“But the agency [FDA] said it doesn’t know the cause of the heparin reactions potentially tied to Baxter’s drug. Baxter said earlier it was focused on differences among batches of the heparin. It offered few details, but yesterday Baxter disclosed that the variations from standard product occurred in the Chinese-made batches.”