The Drug Company That Thinks Selling Unregulated Morphine, Civil War-Style, Is OK

You've probably never heard of Lannett (LCI), a supplier of generic morphine tablets. And you've never heard of its Cody Labs unit, based in Wyoming, which makes those pills. But over the last five years Lannett controlled 50 percent of the market for some versions of morphine sulphate -- a painkiller from the 1800s that's still commonly used in hospitals -- even though it has never had FDA approval to sell morphine.

Since 2006, the FDA has been cracking down on the limbo-like "unapproved drug" market, in which thousands of old, generic drugs are dispensed by pharmacists even though they never got FDA approval. The reason the law allows this is because when the FDA was granted full regulatory power over drugs in 1938 there was a "grandfather" provision that allowed any drug already on the market to stay on the market without FDA approval. That included morphine, the favored drug of swooning Victorian ladies and wounded Civil War soldiers. Unregulated morphine has been on the market for 150 years.

The FDA sent a warning letter last year to Lannett and Cody, demanding that it stop selling morphine without an FDA permit. The move came as part of the FDA's attempt to clean up the unapproved drugs racket. Basically, the FDA is saying to makers that if they don't get their old drugs approved through the modern process -- which looks at efficacy and safety -- then they can't make old, unproven drugs. Only a complete idiot would believe that prescription drugs should not be regulated for safety and efficacy.

Now Lannett is suing the FDA, claiming its actions are unfair and have handed an "artificial monopoly" on morphine to Boehringer Ingelheim's Roxane Labs, a much larger company, which was the first to file to get a "new drug approval" designation from the FDA for morphine sulfate. If the FDA does not also grant Lannett an expedited approval for morphine, it will close with the loss of 90 jobs in Cody, Wyoming, Lannett claims. Lannett will lose this fight, for the reason the FDA describes in its unusually tart response to the suit:

If plaintiffs' argument were accepted, then anyone could market a drug that was on the market prior to 1938 and claim it was "grandfathered" -- and thus avoid FDA approval. This is an absurd argument.

Toldja!: BNET warned its readers in March 2009 that exactly this scenario would happen.

Related:

• How the FDA's Crackdown on Unapproved Drugs Could Create New Monopolies