By my accounting, the FDA has just issued its fourth approvable letter so far in 2008. Compare that to 2007 when by this date, the agency had issued a whopping 12 approvable letters. And, according to an article carried on Pharmalot, the number of approvals has risen over last year.
The latest approvable letter was issued by the FDA on Friday, this time going to Salix Pharmaceuticals for balsalazide tablet studied as a treatment of mild–to–moderate active ulcerative colitis in patients 18 years and older.
No indication was given by the company as to the reasoning for the FDA determination or the timing for resolving issues.
Quick refresher on approvable letters – they are proprietary to the company, meaning only the company can reveal the contents. They mean that the FDA is willing to consider approval, but wants to see something done first. That "something" can be as easy as a label or name change, or as complicated, expensive and time-consuming as new trials to further define safety or efficacy.
Following the announcement on Friday, the Salix shares dropped nearly 4.67%.
Approvable letters, now more properly called Complete Response (CR)letters, are purely legal mechanisms created by the numerous full time attorneys working for the FDA. The consequences to the applicant are the same whether a CR is issued or a denial is issued. The only differnce is the CR protects the FDA from legal or Congressional oversight and minimizes the applicants due process rights.
I do not know why these companies don’t band together to stop this FDA legal nonsense.
WAKE UP!!
One must have to think like a lawyer to see sinister/tactical legal motivation behind all approvable letters. Same type of reasoning would suggest that many companies fail to fully disclose the approvable letters because it would show they messed up and could have gotten a denial. The refresher above well points out scope of what may be involved and is a direct communication/guidance about inadequacies from the FDA on how to gain approval.
At the same time would agree such letters have been apparently used for a delay in action but considering demanding approval timelines plus limited staff it could be a tool for enabling thorough review required given the constraints.
Hi kerry and Anon,
I am a student and came across this question:
What are approvable and not approvable letters? In addition to a decision on approvability, what else might the FDA address in these letters? If the FDA approves Quiessence, what additional parameters or post marketing commitments might be included in the letter?
I tried to search for answer but i got only more confused. Can you help me understand this?