FDA Commissioner Speaks Out on Innovation

For the first time in recent history, an FDA insider has been nominated to become FDA Commissioner. Lester M. Crawford, D.V.M., Ph.D., the current Acting FDA Commissioner has been nominated by President Bush to become the next FDA Commissioner. Following are selected excerpts from his testimony before Congress during his confirmation hearing.

“My vision for the future of FDA is one of transformation. Internally at FDA, we’re transforming from domestic-focused, paper-based processes, employing yesterday’s technologies, to global, electronic-data driven decisions that apply the latest science. And we’re transforming our culture to one of transparency, collaboration, and cutting-edge thinking."

“By adopting a quality systems approach in all of our operations, we will increase productivity and promote better health outcomes.”

“As we confront 21st century challenges, 21st century solutions are key; that is why “innovation” will be at the center of everything FDA does in the time ahead.”

What can we learn from Dr. Crawford’s words?

1. He intends to lead the FDA in a transformation process. This means change. Big change.
2. He plans to adopt a quality systems approach to achieve this transformation.
3. Innovation will be at the center of everything FDA does.

What does that mean for FDA regulated industries?

It means that FDA will expect us to also adopt quality systems approaches. Several of FDA’s key initiatives and guidelines over the past two years point right to taking a quality systems approach.

It means FDA will expect us to use innovation as a key driver in our businesses as well - innovation of products as well as innovation of processes.

In fact, FDA recently released a report titled “Innovation or Stagnation.” You can download and read this report at http://www.gmptrainingsystems.com/asp/articles.asp

You can wait for FDA to “force” you to adopt a quality systems approach and begin innovating your processes. Or you can take the initiative and get moving. Stay ahead of FDA. It will save you time, money, and headaches.

You can increase your personal and your organization’s Innovation Instinct.

Innovation Instinct is the ability to generate valuable ideas, build on them, and most importantly, implement them.

Go to www.InnovationBootCamp.com

to learn how we can help you stay ahead of the FDA.