When the FDA gets tough . . .

Let's see. If I were making a pile of money by doing something illegal and I got caught, do you think I'd be able to get off just by agreeing not to do it again? I guess if what I was doing was making illegal prescription drugs, I could. I'll make a mental note:

The U.S. Food and Drug Administration (FDA) announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, Mark Tengler, PharmaFab's president, and Russ McMahen, PFab's vice president of scientific affairs, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. The case was filed in the United States District Court for the Northern District of Texas.

"Drug approval and CGMP compliance are part of the foundation of drug safety," said Steven K. Galson, M.D., M.P.H, director of FDA's Center for Drug Evaluation and Research (CDER). "When companies and individuals choose not to comply with the law, FDA must deal with these problems decisively." (FDA Press Release)

Wow. Their knuckles must really be a-hurtin' from that rapping. Even though the infractions, involving unapproved drug manufacturing, are certainly minor:

According to the complaint filed with the court, PharmaFab did not comply with CGMP by not investigating manufacturing failures and not recording and justifying why it deviated from written manufacturing procedures. Further, the company lacked an effective quality control unit and failed to establish reliable expiration dates for products. Compliance with CGMP is necessary to ensure that drugs have the requisite safety, identity, strength, quality, and purity.

No big deal. Under the consent decree they've got to destroy certain illegal drugs and not distribute any without obtaining FDA approval. Gee, you need a consent decree for that? I thought that was the law. But what do I know. This time the FDA means business:

"FDA will not hesitate to pursue enforcement action when necessary," said Margaret O'K. Glavin, FDA's associate commissioner for regulatory affairs. "We will continue to protect public health by carefully monitoring the provisions of this injunction. FDA will also continue to investigate and take action against other marketers of unapproved drugs."

Of course I would think it would be much easier to monitor them if they were in jail, or something. After all, it's not like there aren't other people in jail for selling illegal drugs. But maybe these guys aren't eligible. They're probably white and rich. You need to be a black teen with a half ounce to qualify for special treatment.

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Jeb: Partial list on the FDA press release at the link.

Similarly, identity theft and fraud turn out to be, not serious crimes, but simply stock-price-affecting embarrassments when done by HP. And there are a million other examples.

Someone ought to propose a set of ideas under which the same laws applied to everyone, rich and poor, weak and powerful, black and white. Everyone could be entitled to a jury trial, impartial court, maybe even a lawyer paid for by the public if necessary. We could call this set of ideas something really catchy, like "the rule of law." And then, we could expect even really powerful people to, you know, either obey the law or actually go to jail.

By albatross (not verified) on 01 May 2007 #permalink