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It wasn't too long ago that I was sitting in this very spot, desperately trying to meet the deadline for the Special Report “DNA: The Crystal Ball” (see CleanRooms, March 2001, p. 21).
None of the drug-makers experimenting with genomic technology wanted to talk to me. I was enraged, yet I kept it all in check, despite seeing some of the same information I was looking for in magazines that are found on newsstands.
It wasn't until I read a news story in The Star-Ledger of New Jersey that I began to think maybe my brash opinions were not quite unfounded.
That news story, which was published by many other media outlets, indicates that some of the world's largest drug makers do not seem to give a damn about the quality of the products they sell. In fact, many have been heavily penalized with some the stiffest fines in history for ignoring demands from the U.S. Food and Drug Administration to clean up sloppy manufacturing practices.
It's unconscionable, really, that the pharmaceutical industry conducts itself like some tobacco mogul. Here's an industry that can pretty much dictate the future of well-being, and while many of its players are blazing trails, some of the major forces are exhibiting a total disregard for regulations that are put in place to protect us.
Sure, there are plenty of drug makers out there who follow the law to the letter and take pride in the products they manufacture, but it would seem the heavy-hitters are perfectly content with ignoring the federal government and paying millions of dollars in fines. It's almost as if noncompliance is a line item in their budgets.
Equally alarming is that the FDA does not have enough inspectors to do its job effectively, although the agency does not seem to be having a problem cranking out new drug approvals. I'm not sure which is worse: A shoddy drug manufacturer or a federal agency that's losing its muscle.
Whatever the case, it's time for world leaders as well as pharmaceutical and medical professionals alike to think about what the words “life sciences” mean and do their part to uphold regulatory measures and ensure profits do not take precedent.
I would really like to know why Abbott Laboratories ignored FDA warning letters for six years or how drugs at Genetech Inc. were contaminated as well as why they were exposed to “unusual conditions.” But I highly doubt they'll return my calls, and that's just fine, for I rejoice in the fact that I can get exactly what I'm looking for from the FDA under the Freedom of Information Act.
That's not to say I'm not accessible either. My phone number is (603) 891-9429. If I'm not here, just leave a message. Maybe I'll return the call.
Mark A. DeSorbo
Associate Editor