Biotech Values

[poorgradstudent]

If XYZ Company wanted to apply for a drug wouldn't it be more beneficial if the FDA assigned someone to work inhouse at XYZ company and guide, question or verify all the steps or questions prior to submission. The submission should be clean when it's transmitted. Let XYZ pay the whole salary stucture during he process.

?

1) Companies are not restricted from conferring with the FDA.

2) I would wager that the problem isn't the companies having no clue what the FDA wants, but rather that most companies try to cut corners. So I don't think you need a dedicated FDA liaison, as I'm quite sure sponsors can easily design robust trials if they so choose*. It's more a question of sponsors (especially smaller companies) trying to get the most of the least amount of work / $$$.

3) For the sheer number of new drugs that are introduced into the US market, your working-with-instead-of-against comment is just a talking point. Good drugs get on the market, and those that experience delays are rarely due to a capricious FDA. Subjective case in point: it's easier to name drugs that we think offer little for the price (yet reached market) than to name good drugs that got stonewalled and killed by the FDA.


* Note that larger companies have little trouble designing large, comprehensive development programs such as AMGN's for denosumab.