Exclusive outtakes from industry leaders
Audio – Say What?
Jenkins, the director of the U.S. Food and Drug Administration’s Office of New Drugs, said when companies communicate an FDA action on their products to investors, they sometimes don’t convey it so accurately. Click here to listen to his comments.
“We don’t monitor what the company says routinely about every action that we take,” Jenkins told the Reuters Health Summit in New York. “But there are times when we become aware of what the companies are saying relative to what we know is in the letters and we don’t think they add up.
“There are occasions where we call the companies and voice to them our concern that what they’re saying about what’s in the letter versus what we think the letter actually said are not consistent. There have actually been cases where we’ve referred some of those situations to the (U.S. Securities and Exchange Commission).”
Jenkins said it was “very rare that we see something that we actually go to the trouble of referring to SEC.”
But, he said, “it’s less rare that we see something that we would we call the company up and say, ‘We noted your press release said that no new studies were required for approval, and maybe you didn’t read the letter to the end, but we asked you for a new study.’ “