FDA Under a Hail of Heparin Fire

Washington, DCThe US Food and Drug Administration (FDA) has been called to answer for delays in seizing lots of tainted heparin from a manufacturer in Ohio, adding to the ongoing frustration with regard to the heparin contamination saga. Heparin injection is vital to numerous surgical procedures and medical treatments, and the tainted heparin recall of contaminated heparin from China becomes even more complex when recall delays at the local level has the potential to further compromise safety.

It was back in November that federal agents physically entered the premises of Celsus Laboratories in Cincinnati and removed various lots of contaminated heparin that had previously been recalled.

In fact, it was revealed that the FDA had twice previously communicated with Celsus with respect to lots of contaminated heparin on the premises. The first was during a physical inspection of the facility in April, followed by a second communiqué sent to Celsus on May 8th.

In recent correspondence to Andrew C. von Eschenbach, M.D., who serves as Commissioner of the FDA, Rep. Joe Barton commended the FDA "for your recent seizure of contaminated heparin from a manufacturer in Cincinnati, Ohio."

However in the next breath Barton, who is the ranking Republican on the House Energy Commerce Committee, took the FDA to task for waiting so long before taking action.

"Your November 6, 2008 announcement accompanying the enforcement action indicates that you twice previously informed the manufacturer (during an April 2008 inspection and again in a May 8, 2008, letter) that the company's actions regarding the contaminated heparin were insufficient to assure an effective recall," Barton writes. "I am concerned about this six-month delay between FDA informing the company of its insufficiencies and FDA taking enforcement action…

"Why did FDA wait until November 2008 to seize the contaminated lots?"

Not outlined in Barton's letter, but a worthy question nonetheless, is why the FDA failed to go one step further and remove potentially-contaminated heparin from the shelves of Celsus customers, after previously criticizing Celsus for not doing the same.

Following a physical inspection of the Celsus facility in April, the FDA reportedly issued a request that Celsus physically recall supplies of the tainted heparin from its customers. Celsus responded by notifying their customers, via correspondence, of the suspected or probable contamination.

That wasn't good enough for the FDA, which revisited the issue with Celsus a month later. When Celsus refused any further action, the FDA decided to take matters into its own hands.

A double standard

But only to a point. It would go in, with the aid of federal agents, and physically remove tainted lots of heparin from Celsus stock. However, the FDA has been criticized by Barton and his Committee for waiting months to actually carry out the deed.

And once complete, the FDA failed to undertake what it previously had criticized Celsus for not doing—and that's physically going in and remove the tainted lots of heparin from Celsus customers. What the FDA DID do, was send a letter to Celsus customers, revealing the seizure and reminding them about the contamination issue.

"The FDA's management of the heparin issue continues to be of great interest to me and others on the Committee on Energy and Commerce," Rep. Barton said this month, in the opening statement of his correspondence with Dr. von Eschenbach.

Barton indicated he wanted answers early in the New Year.

Heparin is a widely used blood thinner that remains a part of scores of medical procedures, including dialysis. Heparin is fashioned from the intestines of swine, and much of the global supply of raw heparin is sourced from China, and more specifically a network of unregulated family-run cook huts that defy normal protocols for safety and cleanliness. Whether, or not this cottage industry of heparin huts remains the basis for the contamination remains to be proven.

However, after it was revealed that heparin was emerging as the suspected agent at the root of much illness and even cases of heparin patient death, advanced testing discovered a hard-to-trace heparin mimic that was allegedly added at some point in China to flesh out heparin volumes, while conserving the real ingredient out of an obvious motivation for cost saving and profit potential.

A massive heparin recall ensued. However, the FDA—already under fire for allowing the contaminated heparin into the system in the first place and failing to inspect the primary manufacturing facility in China that lay at the root of the tainted heparin—became alarmed at various delays in the recall process.

Hence the FDA's call to Celsus to get off its duff and get it done. When Celsus vacillated, the FDA stepped in—but delayed its own response by months, not to mention failing to undertake what it had already criticized Celsus for failing to do.

It makes for an interesting double standard, and an explanation Barton is hoping to have in his hands by mid-January.

In the meantime there have been hundreds of adverse reactions, and scores of deaths in the US alone linked to heparin contamination. A failed heparin recall that saw a goodly amount of tainted heparin fall through the cracks doesn't help. While recent reports have noted a marked decrease, if not a complete elimination of any further heparin injury or death from heparin injection since the massive media coverage earned by this story, there are still questions as to why this had to happen in the first place.

Given prior crises originating with China with regard to lead in children's toys, toothpaste tainted with anti-freeze and pet food laced with melamine, why did the FDA not take a proactive stance by monitoring any additional consumable coming in from China? And once the crisis was at hand, might the FDA have reacted more swiftly? Could more injuries have been avoided, and more lives saved?

Rep. Barton and the House Energy & Commerce Committee want to know. And Dr. von Eschenbach might be spending part if his Christmas holiday answering some of those questions.