As we have previously written, the FDA has recently removed the Pacira warning letter from their website, which set off a firestorm of settlement speculation. Pacira made a constitutional challenge against the FDA, alleging that the FDA placed unconstitutional restrictions on Pacira’s commercial speech.
Warning Letter Removal
There are only three previous instances where the FDA withdrew a previously-issued Warning Letter. The first instance involved Van Den Bergh Food Company; the FDA had prepared a Warning Letter but never intended to issue it because the company had corrected the cited issues. The Warning Letter was inadvertently made public by the FDA’s Chicago District Office, and the FDA had to officially withdraw the Warning Letter from public “display,” since the FDA did not post Warning Letters online until 1997.
Another previous warning letter was withdrawn to the Laerdal Manufacturing Corporation. The letter cited the company for GMP violations which were subject to earlier litigation, of which the FDA was on the losing end.
Lastly, the FDA withdrew a warning letter that was issued to Ophtec, a device manufacturer, because the violations alleged by the FDA in the letter were “factually inaccurate.”
Case Proceeding Changes
In addition to the Pacira warning letter coming down off of the FDA’s website, the court has changed the judge hearing the Pacira case: the case has been reassigned from Judge Edward Ramos to Judge Lewis A. Kaplan. Judge Kaplan originally granted the FDA/DOJ an extension on their response to Pacira’s complaint to November 16th; the response was previously due Monday, October 26th.
Judge Kaplan’s decision to allow an extension on the response due date has set off more talks of settlement between the FDA and Pacira.
Speculation
The removal of the letter has piqued the industry’s interest and it is speculated that it could have been removed for one of two reasons: One, the withdrawal of the letter could be a condition of any settlement between the FDA and Pacira and the FDA could be removing the letter now to prove good faith in settlement talks. Two, if the case continues to proceed, the FDA may challenge the justiciability (whether the matter is ripe for ruling) of Pacira’s equitable relief claims, given that the withdrawal of the Warning Letter suggests Pacira does not face an immediate threat of harm. This is a similar approach to one the FDA tried in Amarin.
However, no one can be certain of what is going on behind closed doors with talks between the FDA and Pacira. If they are working towards a settlement, they can of course fail to reach a settlement, and still go all the way to trial. Judge Kaplan seems to be open to giving the parties the time they need to talk it out and try to get it settled out of court; he is willing to potentially grant another extension if the parties cannot reach a settlement by November 16th, but are still willing to discuss settlement with each other.
In preparation for the case going through to trial, two groups filed amicus briefs over the past couple weeks: PhRMA and Medical Information Working Group, an “informal working group of manufacturers of prescription drugs, biologics, and medical devices.”
We will continue to monitor the progress of this case and will cover any settlement or progression made.