Hiding in plain sight: the FDA’s approach to disclosing new drug applications is a disservice to public health

Stat News

4 June 2019 - Remember in high school when a friend told you a secret and you guarded it assiduously, only to find out that most of your classmates were already in on it? 

That’s a fair description of the secrecy surrounding elements of the FDA's drug approval process.

As several of my former FDA colleagues and I describe in a report published Monday in JAMA Internal Medicine, it’s an open secret when a company files a new drug application (NDA), despite the FDA’s decades-long practice of treating those filings as “confidential commercial information.” That secrecy, a crucial element in the FDA’s approach to transparency, results in its withholding reams of documents under the Freedom of Information Act. (Some of this withholding — of trade secret information, for example — is eminently reasonable.)

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Michael Wonder

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Michael Wonder