Matt Herper over at Forbes has a very cogent perspective piece up today on FDA’s so-called “black box process” for unapproved drugs — it has this to say about Schering’s sugammadex:
. . . .[T]he U.S. Food and Drug Administration shocked investors on Aug. 1 by rejecting sugammadex. Schering relayed the news in a 447-word press release, explaining that the FDA’s concerns were “primarily related to hypersensitivity/allergic reactions,” a known and rare side effect of the drug.
Those six words are all that investors and concerned anesthesiologists are likely to get in the way of explanation for the surprise rejection. As a matter of law, the FDA must keep communications about unapproved drugs confidential.
That silence reflects larger ways in which the agency is having trouble adapting to a world of super-sudden stock movements, Internet-speed rumors and an unrelenting 24-hour news cycle.
“One thing I’ve said now for several years is, if a company is telling you about the letter, I would ask to see the letter, because that’s the only way to know what the FDA said,” says John Jenkins, director of the FDA’s Office of New Drugs. . . .
That is very-solid advice, Mr. Jenkins — but what are we to think about the case where a company (think Schering, here) simply declines to provide the letter? Said another way, is it time to rethink the FDA’s letter policies/right of public access rules? Perhaps.
More to come, later. . . .