Regulators (especially those of the FDA variety) love ambiguity – because ambiguity is power. But regulatory ambiguity invariably leads to mission creep.
Presented for your examination, this short codicil from the recently signed PDUFA legislation:
SEC. 311. EXTRATERRITORIAL JURISDICTION.
‘‘There is extraterritorial jurisdiction over any violation of this Act relating to any article regulated under this Act if such article was intended for import into the United States or if any act in furtherance of the violation was committed in the United States.’’
Whether this was written incorrectly or intentionally written in an overbroad fashion, it’s now the law of the land. But what does it mean?
To answer that question we need to address ambiguity’s regulatory cousin -- intent. Here’s a what-if scenario:
Acme Pharmaceutical Company has a drug that is both EMA and FDA approved. Acme wants to report on the results of a new clinical trial conducted for EMA appraisal. The clinical trial is for a use not currently approved by the FDA. Acme sends out a press release to European media. The story runs in European newspapers. The New York Times (via its London bureau) picks up the story.
Could Acme (because of the story in the New York Times) be accused by the FDA of off-label promotion?
Here’s the key question – was Acme’s intent to have the story picked up by a US media outlet?
Internal company debates often focus on responsibility for an FDA violation after the fact. Section 311 makes it clear that more wide-ranging discussions need to happen beforehand. What is the intent? Is it marketing-driven or is it being done in the best interest of a patient or the broader public health? (PS/ these two things are not mutually exclusive.) Intent counts. Just as the FDA has asked whether or not the speaker and the audience matters when it comes to the issue of “scientific exchange,” so too is this relevant in helping to determine “responsibility” for “extraterritorial” off-label conversations.
As the FDA asked in its December Federal Register notice, “How do companies generally separate scientific roles and promotional roles within their corporate structures?” How indeed?
To paraphrase the proverb, ““The smallest intention is more important than the greatest deed.”