"This is literally a life-and-death issue that must be handled with great care."
-- Celgene (NASDAQ:CELG) spokesman Brian Gill, as quoted in The Wall Street Journal.

Was he talking about warning patients about potential side effects? Pulling a drug off the market? No. The life-and-death situation has to do with scientists at Celgene's competitors.

"How kind," you say? Not really.

Generic drugmakers like Teva Pharmaceuticals (NASDAQ:TEVA) and Mylan (NASDAQ:MYL) need samples of brand-name drugs, in order to run tests proving to the FDA that their copycat versions are the same. But Celgene, GlaxoSmithKline (NYSE:GSK), Novartis (NYSE:NVS), and Bayer have reportedly refused to sell bulk supplies to generic drugmakers, because the drugs in question have special safety programs to make sure that only the right patients get the drug. Since the generic drugmakers aren't patients, they can't enroll in the programs, and therefore can't buy the drug to use as a reference. The Federal Trade Commission is reportedly concerned about the issue.

I'm all for pharmaceutical companies protecting their brand, but they seem to have crossed the line here. Celgene's safety-program, System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.), for instance, is there to prevent use of the drug by patients who shouldn't be taking Thalomid -- people like pregnant women -- because the drug causes birth defects. But really, scientists in laboratories are probably smart enough not to use it, whether they're pregnant or not.

Some of the blame probably belongs with the FDA. The rules setting up such safety programs as S.T.E.P.S. aren't exactly clear on whether or not generic drugmakers can buy those drugs. The branded drugmakers interpret them one way, the generic makers another. Dr. Reddy's Laboratories (NYSE:RDY) has submitted a petition asking the FDA to make a ruling, so some clarity on the situation may be coming.

I hope the FDA remembers that branded drugs aren't cheap, which makes this dispute no less of a life-and-death situation for some low-income families.

That’s my take. What do you think? Just part of doing business, or have the pharmaceutical companies stepped over the line by using safety issues to block competition? Let me know in the comments section below.