John Jenkins, the head of the FDA's Office of New Drugs, has the perfect cure for a chronic rash of poorly conceived new drug applications: Sunshine. And plenty of it, according to a piece in The RPM Report. Jenkins suggests that the agency's complete response letters should be made public when a new therapy doesn't make the cut at the FDA. And the prospect of a public lashing by regulators--complete with all the details explaining why the drug was rejected--would go a long way toward improving the average NDA.
"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. If the FDA got better applications, he went on, then maybe the agency wouldn't be stuck at a 30 percent approval rate for first-time NDAs.
"It tells everybody what the issues are," agrees Steve Nissen of the Cleveland Clinic, a frequent critic of the pharma industry. "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."
Don't expect a lot of support, though, from the development world. Andrea Masciale, senior director of regulatory affairs for Johnson & Johnson, noted that any release would first have to redact trade secrets. Biotech companies frequently omit any kind of detailed explanation about NDA rejections. It would be hard to imagine that the developers would like to see all the details spilled out in the public.