The FDA has been talking up transparency lately and at a conference last week, John Jenkins, who heads the Office of New Drugs, suggested that it could be a good thing to publicly release the contents of those 'complete response letters' sent about drugs that don't make the grade, according toThe RPM Report.
Simply put, public disclosure of any failings in an application may shame drugmakers into submitting better, more complete applications. "I have to wonder if the complete response letter were released publicly, would you wait to submit your application until it was really ready, so that you would have a better chance of getting a first-cycle approval," he said at the FDA/CMS Summit. He noted the rate of first-cycle approvals for standard applications has been stuck at 30 percent for most of the PDUFA era.
But there could be a rub. Andrea Masciale, senior director of regulatory affairs for Johnson & Johnson, didn't object to releasing complete response letters, so long as redactions protect "obvious trade secret, confidential commercial information." Of course, we can imagine what the redaction process would be like.
Not surprisingly, Steve Nissen of the Cleveland Clinic insisted the letters be disclosed fully. "It tells everybody what the issues are. It allows us to kind of think about it, and allows other companies to understand what the issues are. There's just absolutely no rationale for keeping those letters secret...if we want to restore credibility with the public, then we have to get the black box opened up. This is one of the key reasons why there is a lack of public respect for the process that goes on."
[Full disclosure: the FDA/CMS Summit was sponsored by Elsevier Business Intelligence, which publishes The Pink Sheet, where Ed Silverman works as an editor and writer].