This is not a paid advertisement, but I'm dismayed by some of the criticism of FDA today.
Like any human organization, FDA is not without its failings and flaws, but I find the Agency's recent history extremely interesting and important, and its future closely tied to that of the industry. I also admire those forward-thinking scientists within FDA who have been trying to change the status quo. Will they succeed?
Ironically, the Agency that created a risk-averse drug industry has since become a key motivator to get that industry to change, and to take a systematic approach to controlling its processes. Only, some of FDA's efforts are now being interpreted as "getting too cozy" with drug makers.
All politics aside, the drug industry has become so risk averse that, at many companies, even the simplest of changes triggers a Greek Chorus of criticism from QC and QA bureaucrats.
In one humorous example (mentioned in this article), a drug company implementing Lean worked with a consultant to develop a new spreadsheet to help systematize and control data that was being kept, on paper, in numerous places. Its Greek Chorus then sprang to action, demanding to have the "Excel source code" that was used to develop the spreadsheet. It took them six weeks to realize that a new excel spreadsheet wasn't a "significant process change."
Stories like that abound, and the chorus only gets much louder when a company tries to implement a new technology or a new software to help it improve a single aspect of manufacturing or development. "Why not just do things the old way?"
I would imagine that the inertia can be overwhelming, and has probably stifled many projects. And that's just on the manufacturing side. Changing the R&D and clinical side promises to be even more difficult.
As someone covering the industry, I find this story to have all the elements of great drama. But it's not exactly the type of thing that sells newspapers...at least, not yet.
Prompting this rant is another great post on the whole topic of FDA's image building by Mark Senak on Eye on FDA.
For what it's worth, I believe that, in addition to the new Commissioner, Dr. Janet Woodcock, Deputy Commissioner of Operations will be the Agency's new voice because she has actually been doing much of the spade work in bringing science to bear in the Agency and the industry.
The Agency's Deputy Commissioner and new Chief Medical Officer had worked at CDER for years, applying the same "modern" concepts that some drug companies are struggling with ---risk management, statistical process control, quality systems---to improve operations, and had worked with outside consultants, and even had progress analyzed by independent third parties.
Now, as CMO, she plans to bring these same principles to bear on the research and clinical side, with the "The Critical Path" initiative.
I interviewed Dr. Woodcock a few weeks ago for an upcoming article, and asked why the Agency weren't launching an aggressive P.R. and outreach effort to talk about Critical Path, and attempt to reach, not only the "man in the street" but also legislators and the media.
First, the Agency's budget doesn't leave room for P.R. razzle dazzle.
But then, the scientists at FDA take the approach that's typical for scientists working in the pharma industry: that the facts should speak for themselves. They don't---not in the age of the two-minute sound bite.
Dr. Woodcock said that she believes that results from some of the Critical Path's key projects will be the most powerful public relations weapon available.
No doubt, they will---and those who follow these developments closely will care a great deal. But those who don't should be given more of a reason to care.
We heard Dr. Woodcock's and Dr. Nasr's missions articulated very clearly a few weeks ago at the IFPAC conference. But, apart from those already familiar with and supporting these efforts, who else was there to hear them?
Is FDA "preaching to the choir" about these new projects?
I wonder how many reporters will attend the ISPE and AAPS cosponsored meeting on Pharmaceutical Quality Initiatives in Maryland on February 28, where the Commissioner, Dr. Woodcock, and Dr. Nasr, chief architect of FDA's Quality by Design initiative, will discuss these efforts.
I think that FDA should invite the general press to attend "hidden" meetings like this, where critical initiatives are discussed.
Yet I can imagine anyone's, especially a news reporter's, eyes glazing over at the prospect of attending a meeting on ..."Quality Intiatives?" Yawn.
Yet, these concepts are at the heart of everything important that the industry and FDA are trying to address.
Success will ultimately mean safer, less expensive drugs for the consumer; failure, the status quo, price controls and diminished innovation.
-AMS
