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].
2 Comments
I disagree with Nissen. Complete response letters are the new "approvable" letters and usually contain very specific instructions to the Sponsor as to which additional studies, data, etc are necessary for final approval. This information should be considered proprietary for obvious competitive reasons. These letters usually contain little of public health value. The only ones to benefit from disclosure would be stock speculators.
Sorry, I agree with Pharmalot. Pharma companies use the secrecy of the CRL's to abuse investors and mislead them as to the true contents of them. Companies then raise capital after misleading the investors. Without investors, as (I can tell Pharmavet clearly hates them, he is just sadly mistaken to their true value though because it appears he doens't understand capital markets very well), but the fact remains that almost no new drugs would make it to market because nobody would take the risk to develop a new drug if there were not a payout at the end, ie. why we need investors (who take the risk), welcome to capitalism. Too bad for pharma companies. If they hadn't abused the process then this might not be an issue, but they have abused the secrecy granted to them. Finally, the FDA is a government agency, seeing transparency into why some snakeoil drug got denied is 100% completely reasonable. Pharmavet, trade secrets are protected by patents, so sorry there goes your whole argument right out the window.