Sarepta says its secrecy is a matter of respect

When the FDA rejects a drug, it sends the company in question an appendix-laden document detailing its reasoning. That document is not made public by the FDA, but there’s nothing barring companies from releasing it into the world.

So why won’t Sarepta Therapeutics, facing pointed questions about its recently rejected treatment for Duchenne muscular dystrophy, make the FDA’s words publicly available? Because doing so “may be disrespectful to the agency as we work through the issues” in the document, according to Sarepta CEO Doug Ingram, who spoke to DMD patients and families yesterday.

Your mileage with that reasoning may vary, but it’s worth noting that FDA staff has long advised reporters to seek out full rejection letters. And for good reason: A 2015 study conducted by the agency concluded that company press releases often bear little resemblanceto the FDA’s actual communique. The agency has in the past proposed publishing rejection letters, with trade secrets redacted, but ran into industry opposition.

All of which is to say FDA reviewers probably wouldn’t mind if companies published the letters themselves. They might even consider it a sign of respect.