(Remarks as prepared for delivery)
Good morning. Thank you, Eva [Tempkin], for that kind introduction.
I’m pleased to see so many of you joining us – both in person and virtually – for this important public workshop on biosimilars.
I am especially delighted to welcome to White Oak Tara Koslov, Chief of Staff at our partner agency in this endeavor, the Federal Trade Commission.
The focus of today’s meeting is an important one -- to discuss the FDA and FTC's collaborative efforts concerning the biologic marketplace and biosimilars, one of the most promising, exciting, and challenging areas of medical science today, which offers the potential for an enormous positive impact on the health of Americans.
Last month, as you know, we signed a Joint Statement on our collaboration, which outlined our shared goals and objectives and discussed how our agencies will work together to support competitive markets for biological products.
It also described key steps we intend to take to address false or misleading communications by biological product manufacturers.
We’ve also released a Draft Guidance for Industry: “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products, Questions and Answers.”
And today, we’re holding this workshop, the next important step in this collaboration.
What the partnership of our two agencies means is that our combined, extensive resources and efforts in this area can have a dual focus on both the scientific and legal fronts.
This means we will do everything possible to support a robust marketplace for biological products, including the critical adoption of biosimilar and interchangeable products.
On the scientific end, we are working to support innovation and advance the scientific development of these groundbreaking products.
We’re also engaged (in close partnership with the FTC), in activities designed to help ensure that health care professionals and patients receive truthful and non-misleading information about biological products and to deter anticompetitive behaviors in the market place related to them.
What these activities have in common is the goal of helping to reduce costs and enhance patient access to these important and potentially lifesaving products.
The development of biologics offers us one of the best examples we have today of the potential offered by unprecedented advances in medical science. These products, which may be produced through biotechnology in a living system, are used to diagnose, prevent, treat, and cure diseases and medical conditions.
We’ve seen enormous progress in this field in a relatively short amount of time, and the products are playing an increasingly essential role in treating many serious and life-threatening diseases. In many cases, these products present the only effective treatment option for some patients.
That potential is only expanding as this area of science continues to grow. Last year, we approved ten biosimilars.
That makes a total, since 2015, of 26 biosimilars for nine different reference products. And in the early months of 2020, we have seen continuing strong momentum.
Congress recognized this promise ten years ago, and to support it, passed the Biologics Price Competition and Innovation Act (or BPCI Act).
That law created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.
Similar in concept to what has occurred in the generic space, it was part of Congress’s intent to create greater competition in the medical marketplace, which in turn would lead to increased treatment options for patients and, potentially, reduced health care costs.
In fact, over the last decade, competition in the generic space has saved Americans and the health care system more than a trillion dollars.
This is especially important when it comes to biologics, because these typically complex product are among the most expensive prescription drugs on the market.
Biologics account for a disproportionate amount of overall spending on prescription drugs – making up less than two percent of total prescription volume, but nearly 40 percent of total spending on prescription drugs. And they also represent one of the fastest growing segments of drug spending.
We’ve taken Congress’s goal to heart and are doing everything we can to lower costs, increase accessibility, and help Americans realize the promise of biosimilars.
At the core of our effort is our Biosimilars Action Plan, designed to support the creation of a market that ensures development of safe, effective and affordable biosimilar products.
Our plan applies many of the lessons learned from our successful experience with generic drugs.
We’re already making enormous strides, including:
- Improving the efficiency of the biosimilar and interchangeable product development and approval process;
- Maximizing scientific and regulatory clarity;
- Strengthening the effectiveness of communications and enhancing understanding of biosimilars; and
- Supporting competition and affordability across the market for biologics and biosimilar products.
This last point has special relevance for our partnership with the FTC, and I want to focus on that for a moment.
We know that a free market and enhanced competition supports increased innovation.
But it must be a fair market as well as a free one.
Unfortunately, since the earliest stages of the development of the biologics market, there have been obstacles to increased competition.
We’ve seen efforts by manufacturers to delay competition for biosimilar products.
And we’ve seen the publication of materials that seem designed to create uncertainty about biosimilars and discourage patients and health care providers from using them.
These behaviors have the potential to put innovation at risk, erode public confidence in the product, weaken efforts to lower health costs through competition, and, ultimately, undermine advances in healthcare as potential treatments and cures are unavailable or go unrealized.
To counter these activities, we’ve taken a number of actions, from the creation of a Biosimilar Product Development program, in which we provide development-stage advice to sponsors, to a public education campaign to make sure that patients and providers know that biosimilars are as safe and effective as their respective reference products.
Our collaboration with the FTC is the next step in our efforts to end these types of counterproductive activities.
It will help support and ensure an environment in which biosimilars can fulfill their promise and reach the patients who need them because the market is a competitive and fair one.
The FDA is a science-based organization, and our work is premised on the understanding that decisions must be based on good data and sound science. In this way, we can promote innovation and support the development of new treatments and cures.
But this activity must be conducted on a fair playing field. Patients and the public depend on it.
Our collaboration with the FTC is designed to help ensure this and support us in fulfilling our mission to protect and promote the health of the public.
Today’s meeting is the next step in this process, part of a sustained and continuing partnership with the FTC. And we look forward to the panels and comments throughout the day.
On that note, it is my great pleasure to introduce the Chief of Staff at the FTC, Tara Koslov.
Ms. Koslov has served as Chairman Simons’ Chief of Staff since he was sworn in as Chairman of the FTC on May 1, 2018.
She has worked on health care competition matters throughout her 23-year career at the FTC, including biologics and biosimilars.
Prior to her position as chief of staff, she was Acting Director of the Office of Policy Planning. She is a graduate of Harvard Law and Brown University.
Ladies and gentlemen, Tara Koslov.