by George Miller and Liz Jones
There's no doubt that the FDA is flexing its enforcement muscle these days. That's apparent in its talk about executive prosecutions, and in recent consent decrees. And to back up its "we mean business" posture, the FDA has tightened inspection-to-warning time, halved the time allowed for manufacturers to respond to warnings, and taken a pass on legal reviews prior to sending warning letters.
A warning letter is "a big step up" from a Form 483 inspection observations report, says Jim Prutow, a partner in consultancy PRTM's healthcare practice. "You don't want the FDA guessing about what you're doing or how serious you are," he told us in June. Adds PRTM partner Mark Mynhier, "They want it to get done right, and right the first time."
The agency is beginning to reveal its new persona in the language it uses in warning letters. The careful reader will discern authority, frustration and sometimes even Terminator-like "I'll be bahk" promises. Here are some phrases to watch out for, from warning letters posted over the last year.
- check here and here for non-FDA guidance on responding to warning letters
Word and Phrase Types:
- "Because responses were received more than..."
- "Failure to initiate the complaint investigation promptly"
- "Provide a complete explanation"
- "Concerned about your fundamental understanding"
- "Unjustifiably delayed and terminated prematurely"
- "Despite an incident report from late last year," "Almost a year after it was first seen," and similar phrases
- "Repeat violation," or worse, "serious and repeat violation"
Subcategory: "Your firm has previously made similar assurances"
- "We will evaluate"
- "We find inconsistencie
- "Failure to have sufficient personnel"
- "As labeled"
Common and increasingly common
- "Adequate" and "inadequate"
- "Does not provide assurance"
- "Failure of your quality unit"
- "Puerto Rico"