Call Based on Ideas Raised by Colorado Life Science Community During Innovation Roundtable With FDA Commissioner
In response to needs of patients and the companies that develop their treatments, Colorado U.S. Senator Michael Bennet today called on the Food and Drug Administration (FDA) to strengthen and expand the current Accelerated Approval pathway for promising drugs that have the potential to help patients with serious diseases and to address an unmet medical need.
Bennet’s call, which comes on the heels of an innovation roundtable he hosted with FDA Commissioner Margaret Hamburg and several Colorado companies, researchers and entrepreneurs, was made today in remarks at the Friends of Cancer Research and the Brookings Institution’s Engelberg Center’s 4th Annual Clinical Cancer Research Conference.
Bennet’s remarks, as prepared for delivery, is included below:
Thank you Mark and Ellen for inviting me to speak here today. I have looked at the lineup and I must say – Friends of Cancer Research and the Engelberg Center – you both have put an impressive lineup of experts to speak here today.
You also both have a long history of working closely with the FDA and the National Cancer Institute to deliver new treatments to patients in the safest and quickest way possible.
As you all know, this is the 4th annual Conference on Clinical Cancer Research. The value of this conference can’t be overstated.
It’s created an environment for open dialogue and collaboration that is without match in the biomedical community. And considering the successes you’ve seen, the rest of Washington might want to take note of what’s happening here today.
In my home state of Colorado, patients and the companies that serve them are wondering how the FDA can help advance medical innovation and support job growth in the 21st century.
At a time when science is progressing at such a rapid pace, it is partnerships like this one that are essential to developing the new medicines of tomorrow.
This is a goal we all share.
Commissioner Hamburg, who will be speaking this afternoon, has also taken this issue head on.
A report released by the FDA last week showed that the agency had approved 35 innovative drugs in the last fiscal year alone.
Dr. Hamburg has my full support in the FDA’s continued work to define and ultimately advance safe and timely approval of groundbreaking drugs that have the potential to save lives and create jobs.
But we can and must do more. We cannot forget at the end of the day who our work ultimately affects – the patients.
Cancer patients in particular are faced by a number of FDA-related challenges – clinical trials, drug shortages, burdensome conflict of interest requirements on advisory committees, and the need for a well-funded FDA, just to name a few – not to mention finding a cure.
The drug development and approval process in the United States can be as expensive as it is protracted, with uncertain outcomes that can take over a decade to materialize.
As the FDA undergoes its Regulatory Science Initiative, we also need to ensure that the scientific community and patients feel confidence in the FDA’s ability to consistently adapt to the latest science and technology.
For example, what happens when there is no surrogate endpoint for an innovative therapy?
Or when a breakthrough therapy shows promising results under the Accelerated Approval process, how can the FDA modernize and adapt clinical trials to learn as much as possible as early as possible?
Can we expedite development of new drugs that show a high magnitude of benefit, especially for patients with no other options?
There are no easy answers here. But I know that working together with FDA, the scientific community, patients, and industry, we can make the paradigm work better.
No matter what, we cannot lower the bar on FDA’s standards for safety. As regulatory science develops, we need to strengthen and expand the Accelerated Approval pathway for drug development that addresses unmet needs.
And that is where you all come in – partnerships like this one help fuel medical innovation and discovery in the 21st century.
I am not the expert on these issues – you all are. The work you are doing may not necessarily take place in plain view, but I can tell you that it is not going unnoticed.
With that, I want to say thank you for everything you are doing and for allowing me to share a few words with you today. Have a great conference.