FDA: Capturing the Benefits of Competition for Patients

Speech by Scott Gottlieb, MD
Commissioner of Food and Drugs
America’s Health Insurance Plans’ (AHIP) National Health Policy Conference
“Capturing the Benefits of Competition for Patients”
March 7, 2018
Washington, DC

Good morning, and thank you for inviting me to speak today about “Affording Tomorrow’s Cures.”

To some, this may seem to be an unfitting topic for me to discuss: the FDA, after all, doesn’t — and shouldn’t — regulate drug prices.

The FDA’s mission is to promote and protect public health, and helping ensure access to medicine is a vital part of this mission.

One of the primary ways that FDA helps create access is through efficient review of drug and biologic applications to determine if they’re safe and effective for their intended use.

But Congress also has charged FDA with advancing policies that maintain a balance between encouraging and rewarding medical innovation and facilitating robust and timely market competition.

And access to medicines is a matter of public health.

I want to focus my remarks today on access to generic and other follow-on medicines and, in particular, on the market for biosimilars – or follow on versions of branded, innovator biologics.

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