PAT Won't Be Mandated (But Don't Look for Any New Incentives Either): CDER Deputy Director Webber

At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.

Ajaz Hussain had once gently hinted that this might be the case at some point in the future. Another question was whether incentives might be offered to "fast track" drug approvals that used PAT. Webber's answers were negative on both counts...mandating PAT, he said, would pose supply risks for critical drugs and lead to too heavy a review workload...to hear it, straight from the FDA, click on to listen to these very quick video clips (2 minutes each). We'll be posting excerpts from Mr. Webber's presentation shortly. Here are his comments on mandating PAT and on incentives.

Frankly, I think that PAT should be required for generics. And fast tracking applications would definitely get the CEO's attention (and predispose him or her to invest in PAT and QbD). As Pedro Hernandez noted, there's little incentive for most companies' top management (given their specific and hard-to-change biases, mindset and goals) to invest in the controls required for PAT and QbD when, down the line, generics manufacturers can enter the market without implementing any of that.

Just being smart about manufacturing and saving incrementally across their operations, even if that savings adds up considerably, doesn't seem get their attention--especially at a time when profits are still pretty high (relative to those in commodity markets).   "Regulatory flexibility" doesn't seem to attract them either. Maybe they need to read John Avellanet's new book (a review for which is coming soon).

But what do you think? Not that you're all clamoring for more requirements...is the idea of incentives simply too naive? 

(Or perhaps FDA could hire contract help from companies like TCS--or trainees from PMI?--to jump start the review process by dividing applications into four piles:  those using true PAT/QbD, those showing process knowledge, those doing things the old way, and those doing things the wrong way....and then pass them along to the reviewers....)

I know that none of you will write in, but thought I'd ask anyway.

AMS

 

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