OMG! Did you hear that Kim Kardashian got slapped down by the Food and Drug Administration this week?
I'm sure not many healthcare officials and practitioners keep up with the Kardashians, but it may become a new requirement of the job, especially now that the courts are leaning toward giving drug companies unlimited freedom of speech rights to promote their drugs off-label.
The pregnant media presence (child #2 with Kanye West) last month sent her 42 million Instagram followers a post revealing her “#morningsickness has been pretty bad.” So, after talking to her doctor, “he prescribed me #Diclegis, and I felt a lot better and most importantly, it's been studied and there was no increased risk to the baby.”
She also revealed she was partnering with Duchesnay (the drug's Canadian manufacturer) “to raise awareness about treating morning sickness.”
Diclegis is a combination pill pulled from the market in 1983 after a number of lawsuits led to findings it caused birth defects. Duchesnay brought it back after it sponsored a clinical trial proving to the FDA's satisfaction that it didn't.
But the FDA did warn in its approval letter that Diclegis hasn't been studied in women with severe morning sickness – the ones most likely to seek out prescription drug relief. It also warned people who take the drug should be aware not to drive or use machinery since “somnolence” is its most common side effect. In its letter to Duchesnay two days ago, the FDA blasted the firm and its partner for omitting any risk information from her post.
So what does that have to do with a recent ruling in a federal court case in New York that said the FDA couldn't prohibit drug companies from discussing unapproved uses of drugs as long as the communication was truthful? Diclegis is approved for morning sickness.
If drug companies win the right to conduct “truthful” off-label marketing (the FDA plans to appeal), expect to see a lot more “sponsored” social media posts touting off-label uses of pricey drugs. Thanks to the FDA's slapdown, future posts from Kardashian and other media celebrities now have a roadmap for acceptability: they only have to include the appropriate warning messages to escape FDA sanctions.
“OMG! Did you hear a new clinical trial shows colon cancer drug X also works on skin cancer? It may cause loss of hair, vomiting and extreme fatigue, but I've been doin' too much tannin' and I'm desperate. Even though it's not approved by the FDA, I'm gonna give it a try!”
While you're thinking about the cost implications of that, consider that Diclegis, which sells for $570 for 100 tablets (you take two to four per day), is a combination of pyridoxine and doxylamine. Both those drugs are available over-the-counter and can be bought for about $5 to $10 per 100 tablets, according to MedPage Today.
OMG!
