Gottlieb: We are looking at places where we can make information more accessible. So you saw what we did on the AERS database and on the FAERS database to make it fully searchable. We’re going to be looking at in the very near future trying to make certain documents that are a component of the medical review process that currently aren’t made available at the time of approval, available at the time of approval, that we think would be relevant to patients and providers, especially providers who want to access to bottom line data that they can use to access products.

I think when we go through the efforts of trying to redact documents and figure out how to make things available that currently aren’t available, we’re going to take a public health framework to it and make sure there’s a public health rationale for it. So we might find ways to release on a more wide scale basis clinical documents before we get to things that have more of a policy interest or more interesting to investors, just because we see the public health rationale greater.

But with respect to the letters specifically that are sent to the branded manufacturers at our request by some generic manufacturers, who believe that they’re using REMS as a blocking technique, we’re going to make those public. So I think I’ve talked about that there were 150 requests. The 150 requests are requests that were made by generic companies to evaluate whether or not their REMS is appropriate to provide the safeguards to get access to the drug. We provide the letter back to the generic manufacturer. We presume that sometimes they provide that to the branded company. We don’t know. But if they’re requesting a letter from us, we presume that’s the purpose.

And a subset of those situations, not only do they request that the letter be sent back to them, but they also request that we send the letter to the branded company from FDA. That’s the subset that we’ll make public, the ones where they request we send it to the branded manufacturer. Because in those instances, since we’ve sent it to the branded manufacturer, we have the ability to make it public. In the cases where we’ve only sent it to the generic manufacturer, we would need their permission.

I think the complete response letters, they could be relevant certainly from a clinical standpoint and public health standpoint. They’re probably more relevant from an investment standpoint. That doesn’t mean that they don’t have public health value, because you want capital markets to be efficient. You want investors to be able to make efficient and informed decisions on how they allocate capital, because the capital ultimately is going to lead to the development of new products.

So there is a public health rationale there. But if I’m weighing trying to devote limited resources to try to find ways to create new frameworks and redact documents, the public health value of releasing bottom line information from the clinical development of an approved product that’s going to allow researchers to re-adjudicate results, versus a complete response letter, the bottom line medical information might win out.

Q&A With US FDA Commissioner Scott Gottlieb

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