Thursday, October 14, 2004

It is looking more and more like the violations that led British drug authorities to nix half the U.S. supply of flu vaccine were mostly process problems, not widespread contamination of shots. In other words, the company that made the vaccine was not trying hard enough to keep its factory proficient and pristine.

The British have always had a reputation for being fussy, but what works for selling range rovers and raincoats is not considerate policy if it means a lifesaving vaccine will be kept from patients who do not have an alternative.

The facts will emerge after the U.S. Food and Drug Administration finishes its own inspection of the plant. Right now, nearly half of the nation’s expected supply of flu vaccine is not available this winter because the British government suspended the manufacturing license at the factory in Liverpool that makes it. The British drug authority, the Medicines and Healthcare products Regulatory Agency, said it found vaccines with abnormally high levels of bacteria in them.

But according to testimony from Chiron Corporation, the American biotech firm that makes the vaccine, and word seeping out from British drug authorities, Chiron “failed to conduct operations in accordance with Good Manufacturing Practice regulations of the United Kingdom,” according to the company’s statement to Congress. In other words, the plant did not have enough controls to ensure that vaccines remained free from contamination.

Early word is that only a very small portion of the 50 million doses were actually contaminated. So, why hold up the entire shipment? The British are likely to argue that they cannot tell where in their production process the problems are coming from. Since they cannot find where the contamination is happening, they cannot certify the safety of any of the finished product.

True, these are serious concerns. After all, the product here is a vaccine that people will be injecting into their bodies. But these kinds of process problems are far different from finding widespread evidence of tainted shots. British regulators had a public-health obligation to salvage whatever shots could be unsoiled while they continued to fix the plant and look for the root cause of the problems.

In some cases, even contaminated vaccines can be refiltered and cleaned. The alternative is that Americans will surely die of flu this winter because they could not get a vaccine. Now, even if the American regulators are able to salvage some of the uncontaminated vaccines or clean up tainted shots, releasing them on the heels of the rash British action would be a tough sell. Liability concerns would keep Chiron from wanting the unapproved lots used. And the FDA would still face a tough challenge convincing people the shots are really safe and people should take them.

It did not have to be this way. Confronted with manufacturing problems, the action that the FDA takes is always weighed against its public-health impact. If closing an important drug production line means people will go without lifesaving medicine, the FDA forces the factory to operate under very close regulatory supervision while it fixes the problems. But it lets drug production continue.

This was evidenced most recently in the FDA’s exhaustive efforts to bring the American Red Cross into compliance. What was the agency going to do, turn off the U.S. blood supply? The FDA also did a lot of handholding with BioPort when it was having troubling bringing its plant into pristine shape. BioPort, as the sole manufacturer of anthrax vaccine, was a vital national-security asset.

In deciding what kind of enforcement action to take against a firm that falls out of compliance, the FDA sometimes seeks an injunction, which is a court order that tells the company not to do it again. The court order also raises the stakes if there are additional violations by threatening legal action. In the United States, when the issue at stake is availability of an important medical product, reason prevails.

Not in the United Kingdom. The emerging perception is that the British were nitpicky here because they could afford to be. They had no skin in this game. A full 90 percent of the vaccines that were coming out of the mothballed plant were earmarked for the United States. The British will not be facing needless disease and death this winter. Americans will.

Scott Gottlieb is a physician and fellow at the American Enterprise Institute. Until October, he was senior advisor to the head of the Medicare and Medicaid programs, Dr. Mark McClellan. Previously, Dr. Gottlieb was Director of Medical Policy Development at the Food and Drug Administration.

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