What the Heparin Crisis Should Tell Us - - BioPharm International

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What the Heparin Crisis Should Tell Us


BioPharm International
Volume 21, Issue 3


Laura Bush
As the heparin problem unfolds, it is a good time to emphasize what many of us have said before: The FDA doesn't need fixing, it needs funding. Or, more eloquently stated by my colleague Pat Clinton, in his January editorial for
Pharmaceutical Executive, "The FDA isn't really broken. It's just broke."

As we go to press, the investigations about the adverse events and four deaths caused by Baxter's heparin are just getting underway. The cause remains unknown. Tests have detected differences in lots linked to the adverse events, though, which points to a manufacturing problem. When it was revealed that the active pharmaceutical ingredient was produced in China, all the alarms sounded.

Then, when it came out that the FDA never inspected that plant, Rep. Bart Stupak (D-MI), chair of the House Oversight and Investigations Committee, called for the FDA's leadership to resign.

That is why we should step back and remember a few things.

First—at the time of Stupak's call for heads to roll—we still don't know what caused the problem.

Second, because we don't know the problem's cause, we can't be sure an FDA inspection would have prevented it. Baxter—surely just as expert in quality as the regulators, and just as motivated to prevent errors—inspected the plant six months ago, and came away satisfied with its quality systems.

Third, the missed FDA visit was a preapproval inspection that should have happened in 2004, when Baxter filed a supplemental NDA indicating that its supplier, Scientific Protein Laboratories, would start sourcing the active pharmaceutical ingredient from the Chinese plant. Would a visit in 2004 have prevented problems in late 2007? Hard to say.

The bigger issue this raises, of course, is that even if the FDA had inspected the plant in 2004, it is unlikely a compliance officer would have gone back between then and now. The FDA doesn't have the resources to conduct surveillance inspections of foreign plants more than once every 13 years. And that reinforces my point, that more funding is needed.

Of course, the missed FDA inspection was indeed an error, and should not be taken lightly. According to what we know so far, after the FDA received the filing, the company name sent to the Office of Compliance was that of another firm with a similar name. As a result, the Office evaluated the wrong company—which had a recent inspection history showing compliance—and the right firm was never evaluated.

Another member of Congress said this was an egregious error not caused by limited resources. Perhaps. I have noticed, however, that when individuals and organizations are stretched thin, errors are more frequent. It is also possible that the mistake was linked to the FDA's inadequate IT systems, which badly need an overhaul, which of course requires funding.

If I were going to fault the FDA's leaders for anything at this juncture, it would be for taking so many kidney punches without crying foul. But maybe they don't have much choice, lest they bite the hand that feeds them.

So now, more than ever, is the time to say, let's stop bashing the FDA and start funding it properly. Congress just found $168 billion to distribute to individual Americans in the hopes of forestalling a recession. Could we also find appropriate funds for the agency that regulates 25 cents of every dollar spent in America, and more importantly, ensures the safety of our food and drugs?









Laura Bush is the editor in chief of BioPharm International,

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