Exclusive outtakes from industry leaders
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).”