Holy Morphine!! Drug Showdown in Cody
How did I miss this? Cody Labs in our own Cody, WY, makes pharmaceuticals for the generic drug market. I suppose their priorities are market-driven, but they sure like to sell heavy-duty painkillers.
One of which is morphine sulfate, the drug of choice during the Civil War and my drug of choice after major hip surgery. The doc weaned me after five days, otherwise I would still be on it, or dead. Someone can stick a knife in your gut, you can be strapped to a chair with Rush Limbaugh blaring on, you can still feel pain but you just don’t care. I still think BP’s Tony Hayward was on morphine when he appeared before the US Senate. You might appear interested but YOU JUST DON’T CARE.
Guess what? The FDA has not approved morphine sulfate for manufacture and public use, with one exception: it recently approved manufacture by the same company, Boehringer Ingelheim’s Roxane Labs, whose “pink Viagra” pill for women was recently deep-sixed. (I could tease that “just don’t care” theme out in a totally different direction… but I won’t.)
I don’t know what has been going on at the FDA for the past 72 years since it was established in 1938 with the mission to protect the public from dangerous drugs and badly manufactured drugs. Congress exempted drugs already in use in 1938 from regulation. I’d like to see the lobbyists’ expense sheets related to that gaping loophole. Morphine sulfate had been in use for centuries, and therefore was exempted from regulation.
Huh? What about adulteration, dilution, fraud, contamination, dosage controls, purity, patient advice, doctor advice….. shouldn’t the FDA have been regulating those aspects of morphine sulfate manufacturing and use?
Well, second guess what? The FDA came out of its VanWinkle slumber a few years ago and started sending letters to manufacturers, stating that morphine sulfate is not a drug which is approved and they better stop making it before the FDA goes beyond a nastygram letter.
One wonders why this did not happen in, say, 1938? I’m pretty sure that everyone knew that morphine was powerful and addictive by 1938.
The FDA hit Cody Labs with the warning letter on March 30, 2009. It stated:
“This letter is written in reference to your firm’s marketing of an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Based on the information your firm submitted to FDA’s Drug Registration and Listing System, you manufacture the following prescription drug:
• Morphine Sulfate Solution Immediate Release 20mg/ml
“As labeled, the above product is a drug within the meaning of section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and because it is intended to affect the structure or function of the body. Further, this drug product as manufactured by your firm is a “new drug” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its labeled uses.”
Wow! A “new” drug? It was generally recognized as safe and effective during the Civil War, World War I, a bunch of other wars, cancer treatment for decades and even after my hip surgery.
There is an erosion of confidence in the competence of government in this country. There are some essential functions that we need government to do, like streets and sewers and clean water and crime prevention; safe drug manufacturing falls within these important responsibilities. It makes for better civil order if we have confidence in how government fulfills its duties. This kind of rote brain-dead regulation does not encourage confidence.
The Billings Gazette carried a story on July 25 stating that the FDA is now trying to shut down the Cody Labs facility, at a potential loss of 50 jobs, because it failed to beat the other manufacturer to be the first applicant for new approval. Not because of an unclean plant, or adulteration, or bad quality control, or because the drug had been found to be dangerous. FDA licensed a competitor to make the same drug. Why can’t Cody Labs keep making it? Because only the first applicant would get expedited approval; Cody Labs has to wait another six months.
BNET, a thoughtful internet business news service, has a story dated July 23 on this; BNET thinks the FDA is right and Cody Labs is wrong. I don’t agree. But, third guess what? Wyoming Federal District Judge Alan B. Johnson agrees with the FDA. Cody Labs will have to make something else for a while.