Last week, one of the most prestigious biotech journals had something to say about the FDA's ruling on Dendreon's (Nasdaq: DNDN) potential prostate-cancer treatment, Provenge. But there's no reason the journal's recommended action should be limited to just this case. In fact, it makes a solid argument for why the FDA should be more open with its regulatory decisions in general.
Explain yourself
In its January edition, Nature Biotechnology argues that the FDA should be more forthcoming about the reasoning behind its approvable letter last May for Provenge.
Ever since the approvable letter, which came after a fairly positive advisory panel hearing, the FDA has been under fire -- and faced lawsuits -- from patient advocates, investors, and others for not approving the drug.
Its not that the FDA's naysayers think the drug doesn't work. They just want more evidence of its effectiveness before they give their full approval. But since the hoopla surrounding the FDA's decision is coupled with conflict-of-interest allegations aimed at two advisory panel members, members of Congress have now decided to get involved and have called for an investigation into the FDA's decision.
The Nature editorial argues that with the FDA's Provenge decision causing so much controversy, the agency should make an exception to its standard operating procedure and publicly explain how it reached the decision not to fully approve the drug.
Now, keep talking
I agree with the journal's call for more transparency on the Provenge decision, but the editorial doesn't go far enough. Why should the FDA have to disclose its reasoning in just this instance? Why shouldn't the agency have to provide information on all future approval and rejection decisions it makes?
Encysive (Nasdaq: ENCY) investors, for example, would probably like to know what has held up the approval of Thelin, a pulmonary-hypertension treatment. They can read speculation from blowhard analysts like me, sure, but I'll bet they'd prefer to get the news straight from the horse's mouth.
And wouldn't it be fascinating to know what the FDA's problem is with Novartis' (NYSE: NVS) diabetes-treating drug, Galvus? As things stand, we can only hope that no issues that concern Galvus could affect the whole class of DPP-IV inhibitors. I'm sure that doctors, patients, and other developers of DPP-IV inhibitors, such as Bristol-Myers Squibb (NYSE: BMY), would benefit from knowing exactly what's going on.
Here's another example. With the important prophylactic differences between Merck's (NYSE: MRK) already approved Gardasil and GlaxoSmithKline's (NYSE: GSK) Cervarix -- both of them vaccines against human papillomavirus -- millions of potential patients would benefit greatly from knowing what's causing Cervarix to not get final FDA approval.
A call to arms
No matter what side of the Provenge approval debate you fall on, almost everybody can agree that the FDA sets itself up for criticism from investors, patients, and scholarly publications with its behind-closed-doors approval and rejection decisions. That's especially true when it makes a ruling on a drug that looks inconsistent with some of its previous decisions.
It's inconceivable and inexcusable that a governmental agency, partially funded by taxpayer dollars, can be so secretive about its decision-making processes. I don't agree that the Provenge approvable decision was a bad one, but would it really hurt anyone, or have much of an affect the ongoing phase 3 study, if the FDA stated the reasons why it issued an approvable letter for Provenge last May?
The European Medicines Agency always publishes its reasons for rejecting or approving a drug. At least for accountability reasons, the FDA should be required to do the same with its regulatory decisions.
Requiring public disclosure would bring other benefits as well. As the Nature article mentions, if the FDA published the reasoning behind its decisions, drugmakers would become better prepared to avoid the traps that hold up approvals for their competitors' drugs. The entire drug-development process would become faster and more efficient as a result.
Regardless of whether Provenge is ever approved, forcing the FDA to be more open and accountable for its regulatory decisions on all drugs could be one of the best things to come out of this saga. It's not an unreasonable request. After all, the latest PDUFA regulations passed last year force drugmakers to be more open about their compounds. It's hard to argue that also making the FDA's regulatory decisions more transparent would be anything but good for the drug industry, patients, and the FDA itself.
More Foolish ramblings about the FDA:
