I finally did it!
I have updated the listing of Approvable Letters that is housed in the left column of the blog under Resources by Me. I now have all of the approvable letters listed that I have seen occur. By no means, do I pretend that it is necessarily each and every letter. Approvable letters are proprietary to a company and whether or not a company releases information, or how much information, is within their purview. And whether or not I notice it if they do, well, that is what it is. If you are aware of an approvable letter for 2007 that I failed to pick up, I’d love to hear from you so that I can amend accordingly.
Looking back at 2007, what do we learn? By my count, there were 29 approvable letters during the year, and the month of May in particular, was positively awash with approvable letters. Some companies received multiple approvable letters in 2007, sometimes prompting them to make the unfortunate, and unprofitable, choice to opt for Formal Dispute Resolution. This seems to be particularly true of foreign, small companies.
Some treatment categories are just problematic – ADHD, pain control and anti-depressants being the most obvious example. And even though we are in a severe "risk-averse" environment, one could say that efficacy was every bit as much a factor as safety in the 2007 crop of letters. Fewer had manufacturing concerns. The company suffering the most disappointment was perhaps Wyeth – not only receiving four approvable letters in the same year, but two on the same product. Ouch.
Of one thing I am nearly positive, it was a record year not only for the sheer volume of approvable letters, but for multiple approvable letters. Notably, Labopharm for once-daily Tramadol, Wyeth (already mentioned) for Pristiq, Pozen for Trexima, Encysive for Thelin, and Neurocrine for Indiplon Capsules. And some companies, such as Pfizer with maraviroc, were able to clear up the issues that FDA expressed in the approvable letter in a matter of days.
There are lessons when looking at the list in its entirety.
- For example, Wyeth excepted, multiple letters were primarily issued to companies small in nature and without many products in the U.S. perhaps suggesting that foreign and/or small companies with few products or regulatory experience should seek U.S. assistance to support their regulatory efforts.
- But some very well-experienced companies also received approvable letters this year and in great volume, signaling that the current environment has probably had an impact on the pipeline flow and that the agency is taking much greater measure to examine a myriad of aspects before approval.
- Third, there are some therapeutic categories or particular safety signals that are going to present greater challenge than they might have just a few years ago – and don’t look for that to change.
Good luck in 2008!