Dear Dr. Scott Gottlieb:
Scott, on Tuesday you expressed a desire for the Food and Drug Administration to make public a limited number of complete response letters (CRLs) — the missives the agency sends to drug makers when their marketing applications are rejected. You said these letters could be released if they contain information that might benefit public health.
That’s good, but not good enough.
Speak to your own people if you need more compelling evidence to support a policy shift to fully and publicly disclosing complete response letters. If you ask FDA staff, they will tell you greater transparency is required because, all too often, companies mislead the public about the reasons FDA rejects drugs.
That was the remarkable — and alarming — conclusion of a 2015 study conducted by FDA staff, published in the BMJ. They compiled 61 complete response letters issued from 2008 to 2013 and compared them with company-issued press releases to determine how the content matched up. The results: 21 percent of the press releases shared nothing in common with the CRLs. Thirty-two of the CRLs issued by FDA instructed companies to conduct new clinical trials, but 40 percent of the corresponding company press releases didn’t bother to include that vital information. No press release was issued at all for 18 percent of the FDA’s CRLs.
Drug makers get away with an appalling lack of transparency with respect to CRLs because they know the FDA, under the system now in place, is toothless to say or do anything to stop them. If you’re really interested in improving transparency at the FDA — and benefiting public health — you’ll figure out a way to make all CRLs public. Get to work, Scott.