Twenty-Two Warnings - Pharmaceutical Technology

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Twenty-Two Warnings
It sometimes seems that FDA is constantly admonishing drug-makers for manufacturing shortcomings. The record shows that we are the least unruly of the Agency's charges.


Pharmaceutical Technology


Douglas McCormick
During the too-quiet week between Christmas and New Year's Day, I did a back-of-the-envelope analysis of Warning Letters issued by the US Food and Drug Administration during 2006. I devoted a couple of hours that dislocated week to downloading and categorizing the 455 Warning Letters with which the Agency gladdened the preceding year.

I'm sure that many people celebrated the holidays by doing the same.

Now, making that tally was not exactly a matter of clicking a mouse and getting a cross-tabulation. The agency's online database assigns each letter a subject, but there's little consistency from letter to letter. To take a fundamental example, the letters refer variously to "current good manufacturing practice," "current good manufacturing practices," "good manufacturing practice," "good manufacturing practices," "CGMP," and "GMP." A letter to device manufacturers, for example, might be captioned simply "GMP/Adulterated." Or it might refer to the "Quality System Regulation" or "QSR" or the "Reporting Requirements."

All in all, the 455 admonitions carry 157 distinct subject classifications, most of them merely minor variations.

What this exercise revealed (in addition to my urgent personal need for counseling and a rewarding hobby) is that we—the people who actually make pharmaceuticals—are extraordinarily good at what we do.

FDA's 455 Warnings cover a wide cross-section of US manufacturing. One way or another, FDA regulates about a quarter of the country's economy—anything that's swallowed, injected, inhaled, or spread on the skin.

In the final analysis, just 22 of these Warnings concerned the manufacture of human pharmaceuticals: Fourteen were issued for CGMP violations in finished pharmaceuticals. Four went to API producers. Three to medical gas suppliers. And one for a biologic. (Fourteen more Warnings went out to compounding pharmacies, as the Agency continued its campaign to bring them under GMP control, but that's a story for another time.)

As anyone who has been on the receiving end can attest, even one Warning is about three too many. But compare the 18 Warnings for drug products and substances with the 37 letters sent to investigators, institutional review boards, and laboratories for clinical-trials missteps. Or consider 80-plus Warnings issued to medical device makers. Or those earned by drug marketers for making false and misleading claims or selling unapproved products. Or the 170 or so Warnings sent to various links in the food chain, from makers of medicated feeds to dairymen to seafood processors.

Our industry manufactures billions of doses of medication each year. The Center for Drug Evaluation and Research's list of registered manufacturing facilities runs to more than 11,000 entries. The scope of the activity is mind boggling. Yet we seem to pull it off with greater consistency and integrity than any other sector FDA regulates.

The disparity between the manufacturing and marketing sides of our own industry is particularly interesting. In manufacturing, we have clearly cultivated a culture of quality—though we equally clearly have far to go. It's not that we're unimaginative or uncreative. Rather, we can see only too clearly what will happen to our customers—our patients—if we cross over the limits, no matter how tempting it might be.

Look at the damage done to our industry by pitchmen shading the facts for marketing advantage. Then look at the record on the manufacturing side. It's hard not to feel that the culture of quality is the culture that matters.

Douglas McCormick is editor in chief of Pharmaceutical Technology,

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