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Event Title
Remarks M.D. on Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review
October 02, 2017


Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review Workshop
October 2, 2017

Good morning.  I’m delighted to join you today for this important meeting.

I want to start by acknowledging the work of our staff of our Office of Generic Drugs, who put this meeting together.

Their efforts are helping advance an opportunity that has been a top priority of mine. How do we bring more competition to the drug market, as a way to improve drug access?

And if we can increase generic competition, for many patients this will also help lower their drug costs.

Generic medicines are a key part of enabling access and helping consumers save money.

Consider that in 2016, generic drugs accounted for 89% of all prescriptions in the US.  That meant Americans saved an estimated $227 billion on their health care. 

And that’s just the savings for one year. From 2006 to 2016, generics have saved the American health care system an estimated $1.67 trillion.

So we know that there’s a real opportunity here to make a difference, particularly in the face of the continuing challenge of rising drug prices.

This is one reason why I’ve chosen to make generic drugs – and, more specifically, increased access to quality, affordable generic drugs – a priority issue. And why I’m focusing so much time on this agenda.

As part of FDA’s Drug Competition Action Plan, which I announced when I first arrived at the agency, FDA is pursuing ways to streamline the generics drug review process. Our goal is to help bring greater efficiency and transparency to how we review and approve generic drugs, without losing the clinical and scientific rigor of that process.

Our plan also includes steps we’re taking to block ways that branded companies sometimes game our rules to extend their monopolies longer than Congress intended. Owing in large part to the hard work by FDA’s Office of Generic Drugs, we’ve already made great strides toward achieving these goals.

In June 2017, we published a list of off patent, off-exclusivity branded drugs without approved generics, and also expanded our policy to expedite the review of the first three generic drug applications where competition is limited.

We’re moving to expedite the review of any generic drug application for a product on this list of branded drugs that have no listed patents or exclusivities. Our goal is to ensure that generic competition to drugs that lack competition can come to market as expeditiously as possible.

And just today, the agency published two federal register notices dealing with complex generics. This is a category of medicines that has sometimes been hard to genericize. They represent some very expensive and widely used drugs. The goal of the policies that we’re announcing today is to make it more efficient and, in some cases, more feasible to bring generic competitors to these branded drugs.

We’re going to be announcing other policies in the near future. Among other things, we’re actively looking at ways that we can forestall some of the so-called “gaming tactics” that branded companies engage in as a way to forestall generic entry. We think there are steps we can take to address this practice. I’ll have more to say on that soon.

I mentioned that we’re taking all of these new steps without sacrificing the scientific rigor of the generic review process. Generic medicines are just as safe and effective as their branded counterparts. The generic industry that FDA regulates produces high quality medicines that consumers can trust.

A central aspect of fully implementing my generic drug plan and spurring the innovation and improved regulatory decision-making it’s designed to advance, requires us to employ more rigorous science, quality data, and the use of sophisticated quantitative methods and computational modeling in drug development, evaluation, and review.

This starts with the use of more advanced computing tools, and more sophisticated statistical and computational methodologies as part of the drug development and the generic drug review process.

FDA has already begun to adopt many of these tools, including more widespread use of modeling and simulation, on the new drug side.

Consider that almost all new drug applications for new molecular entities have components of modeling and simulation.

Model-Informed Drug Development has been incorporated into more than 90% of new drugs and biologics currently approved.

This type of information also can enable more efficient approvals of generic drugs.

When it comes to generic drugs, modeling and simulation plays an important role in many aspects of the development and review process.

This includes: integrating diverse data sets, setting up clinically relevant equivalence criteria, evaluating post-market signals on generic switches, exploring alternate study designs, and engaging big data to identify drug competition priorities.

These tools enable safe and effective new generics to advance more efficiently through the different stages of the drug development process.

Knowledge from modeling can improve the first cycle generic approval rate, reduce cost and time of generic drug development, and expedite approval of safe and effective products.

It’s an important start. But while we’re making advances in this area, we still have a long way to go to increase access to these platforms.

That’s why I’m directing an effort to try and increase our investment in these important, computational tools. We’ve been collaborating with internal and external parties who are providing us with the additional expertise and infrastructure necessary to advance the development of these state-of-the-art modeling and simulation technologies and apply them to generic drugs.

Our aim is to make sure that our policies and regulations – and our scientific and clinical standards -- keep pace with the challenges we face in protecting consumers and promoting drug competition and access when it comes to generic medicines.  More access to more high quality generic drugs will give us more ways to advance the public health.

Our announcements today are part of a broader effort by the administration to address the high and rising cost of drugs and we look forward to working with the global regulatory community to fulfill this promise and to create a more robust, safer system for the development of innovative medical products. That’s why today’s meeting is so important. This collaboration is key to all of our success. We appreciate your partnership in these efforts, and I’m grateful for the opportunity to join you for part of today’s meeting.

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