Will Cephalon lobby FOR a black box warning?

The FDA's advisory committee turned thumbs down on Cephalon's request to use modafinil (an anti-narcolepsy drug) for ADHD. According to press accounts, company officials were "shocked."

Really? Some kids in the clinical trials developed serious skin rashes and the drug had one of the highest rates of psychotic episodes among ADHD drugs. It's hard to see why they found the bad news so upsetting.

Yet, as I pointed out Monday, the backstory to this drug involves the company's desire to get any pediatric designation it can to extend its patent life. That's why the competing comments from FDA officials on the future prospects for the drug were so interesting. Thomas Laughren, the chief of the psychiatric drugs division, was downbeat. But Robert Temple, the second-in-command at the new drugs division, said the drug may yet get to market, but with a black box warning.

After getting voted down 12-1 by an advisory committee and getting an extremely negative review from the in-house staff, it will still get to market with a black box warning? What's he been taking?

Perhaps company officials are already lobbying for that outcome. "We will continue our discussions with the FDA to determine the next steps in the review of this drug application," Paul Blake, Cephalon's executive vice president for worldwide medical and regulatory operations, told TheStreet.com.