There was a “fifty-fifty” chance. That’s what the doctors told him.
Even odds, they said, that either of his two younger sons might have the same genetic disease that their older brother, Dominic, had been diagnosed with just two years prior.
That’s why he was already well aware of the fact that those who have it struggle to live past the age of 30.
The news hit him like a brick.
“They told me I needed to take my children home, love them, and provide them with the best quality of life I could,” Richard Romito said.
Three sons. Each one. Duchenne muscular dystrophy. That was nine years ago.
“This is now my life,” he told us.
There is no cure for DMD, but one drug does seem to slow the progression of the disease. It’s called deflazacort.
“Dominic walked a little longer because of it,” Richard said.
In 1995, researchers found it effective against DMD, but until last year no drug company had sought FDA approval to market it in the U.S.
It’s why, for years, Richard Romito purchased deflazacort from a pharmacy in the United Kingdom.
“Roughly $2,400 a year for all three of my kids,” Richard said.
Last year, using the Orphan Drug Act, Marathon Pharmaceuticals sought FDA approval to sell it stateside under the brand name “Emflaza.”
FDA records reviewed by 9Wants to Know show Marathon’s application for Emflaza relied heavily on the 1995 study of deflazacort.
In February, the FDA formally approved Marathon’s application. In doing so, the FDA granted Marathon exclusivity rights for the next seven years. The following day, Marathon announced it planned on selling Emflaza for close to $89,000 a year.
That’s more than Richard Romito’s annual salary as a police officer.
“That’s not right, Chris. That’s not right,” Richard said.
Thanks to FDA exclusivity laws, the Romitos will soon lose the right to import deflazacort into the U.S.
“It’s asinine. It’s not correct. It’s not right,” Richard said.
And while it might be all of that, it’s also not illegal.
In fact, under the Orphan Drug Act, it’s perfectly acceptable. Drug companies like Marathon have been doing it for years, according to an analysis of FDA records by 9Wants to Know.