Bioregnum, FDA

FDA commissioner Scott Gottlieb just broke a public promise on publishing CRLs — and yes, it matters

Scott Gottlieb

In his testimony to the US Senate during his confirmation hearings to lead the FDA, Scott Gottlieb clearly enunciated his position on publishing the complete response letters the FDA sends to biopharmas when regulators reject their new drug applications.

Vowing to achieve greater transparency, Gottlieb promised to open up more. He wrote: “This includes the complete response letters, after proper redaction of commercial confidential information.”

Today, after hinting at it in a few interviews, Gottlieb substantially reneged on that promise. Instead of publishing redacted CRLs, the commissioner now says that he may be willing to publish pieces of some of the rejection notices — provided it serves what the agency deems is a need to provide information relative to public health concerns.

In an address this morning ironically titled “Fostering Transparency to Improve Public Health,” Gottlieb now has this to say on CRLs:

Releasing all the CRLs would be administratively burdensome, given the likelihood we would continue to redact certain proprietary information from these letters. And not all the letters have information that would directly inform clinical practice. For example, many letters primarily relate to manufacturing shortcomings with new drug applications that are eventually resolved.

But some of the letters do contain information that could be directly relevant to patients. We’re evaluating whether there is a subset of the complete response letters where there are especially important public health reasons to redact and release these letters. For example, letters that have safety-related findings or recommendations that could help inform patients and providers about the profile of already-marketed products. Releasing this information could enhance patient safety, by reducing the number of potentially futile trials, and spare patients exposure to potential risks without the prospect of a likely benefit. It can also help better inform clinical practice.

So the FDA, at a time when there are growing concerns that political influence could be shaping the agency’s decisions, now wants to be left in charge of deciding what is an important public health reason and what isn’t.

And why did Gottlieb retreat now? What changed his mind?

Transparency at the FDA is a precious commodity, rarely found and often badly neglected. Why don’t we let the people decide for themselves what is important and what is not in a CRL? If it’s a routine matter that can be easily resolved, then it should be a boon to the company involved to have that released. If the company screwed up their data, can’t prove efficacy or raise unanswered safety issues, regardless of whatever class of drugs — on or off the market — this could relate to, the public has a right to know.

Aside from informing the public about this process, researchers at the NIH, in academia and companies working in drug development all have their own need to see behind the veil.

Everyone has a clear right to what Gottlieb promised to win Senate support — which only repeated his earlier statements supporting the publication of CRLs. It’s all a public health issue, and companies will behave better if they know their own worst missteps will be a matter of public record.

Too burdensome? Then publish without a redaction. Problem solved. Burden lifted. Or just try and match the greater transparency achieved in Europe, where no great hurdles had to be overcome.

As of now, the FDA has reversed itself on three CRLs since Gottlieb took the head office at the FDA. We don’t know for certain what prompted the CRLs, we don’t know why the FDA changed its mind — though we do know that at least one of the companies was willing to lobby senior officials at the agency with a case that it never went public with.

That’s the opposite of transparency.

As of now, this is the first promise Gottlieb has clearly broken.


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