Four US Senators have written to Food & Drug Administration (FDA) commissioner Margaret Hamburg to express their concern about the agency’s use of draft guidance documents to make “substantive policy changes”.
The letter echoes concerns raised by several food companies that while draft guidance is not legally binding, many plaintiffs’ attorneys are nevertheless seizing upon it in consumer class action lawsuits over issues such as evaporated cane juice (ECJ).
For example, in a recent comment to the FDA on ECJ, a coalition of food companies including Chobani and Amy’s Kitchen noted that “Each lawsuit relies heavily on the 2009 Draft Guidance on evaporated cane juice, inaccurately arguing it reflects FDA’s final position.”
Companies affected by the FDA’s recent proposal to crack down on partially hydrogenated oils have also complained that the agency is regulating via ‘tentative determinations’ and draft guidance instead of formal notice-and-comment rulemaking as required by the Administrative Procedure Act.
Many firms feel compelled to follow draft guidance documents as if they were final
In the letter to Commissioner Hamburg, Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.) and Orrin Hatch (R-Utah), claim that draft guidance documents “are increasingly becoming default FDA policy and position”.
While they are technically distributed ‘for comment purposes only’, note the Senators, “In the absence of finalized guidance, drafts are the only information that FDA review staff, patients, clinicians, and FDA-regulated entities have on the agency's most current thinking on important issues.”
And as a result, many firms feel compelled to follow them “as if they were final”, add the Senators, who note that many of these documents are “not being revised, finalized, or withdrawn in a timely manner”, and urge the FDA to spell out what is happening with draft guidances that have already issued.
Draft guidance documents are not being revised, finalized, or withdrawn in a timely manner
Commenting on the letter in the FDA law blog , Hyman, Phelps & McNamara attorney Jeffrey Wasserstein said: “Although the letter doesn’t mention it specifically, we note that some guidances have been kicking around in draft form since the last century.
“Now that the Senate has had its interest piqued by this issue, will it ultimately change FDA’s penchant for issuing draft guidance documents instead of taking the harder (yet ultimately more beneficial) step of implementing substantive policy changes through notice-and-comment rule-making?
"Time will tell, but we’re not overly optimistic.”
Attorney: FDA wants to have its cake and eat it too
So what do other attorneys think? And what is the legal status of draft guidance that has been formally 'finalized'?
Arnold Friede, senior food and drug law attorney with Sandler, Travis & Rosenberg, P.A in Miami, told FoodNavigator-USA: "FDA wants to have its cake and eat it too.
"In any number of litigated cases, FDA has successfully argued that even Final Guidance is just 'guidance', is not binding, and therefore is not judicially reviewable because it does not amount to the 'final agency action' within the meaning of the Administrative Procedure Act."
But he added: "On the other hand, FDA routinely cites Final Guidance -and even Draft Guidance - in enforcement proceedings such as Warning Letters. Industry usually takes Guidance, both Draft and Final pretty seriously. And there is always a big argument in litigation not involving FDA, such as the food advertising litigation or products liability litigation or False Claims Act, whistleblower litigation, about the significance and binding effect of FDA Guidance—draft and final.
"So, like most things in the law, there is no right answer, as such [to the question, 'what is the legal status of finalized guidance?'] It all depends on who the lawyer is representing."