Food and Drug Commissioner Scott Gottlieb, MD, on Monday delivered his first speech to agency staff members.
Here are four quotes from the speech.
On the FDA's role in lowering drug costs:
"[T]oo many consumers are priced out of the medicines they need … I know FDA doesn't play a direct role in drug pricing, but we still need to be taking meaningful steps to get more low cost alternatives to the market, to increase competition and to give consumers more options. This is especially true when it comes to complex drugs and biosimilars."
On the opioid epidemic:
"[U]nquestionably, our greatest immediate challenge is the problem of opioid abuse. This is a public health crisis of staggering human and economic proportion … we have an important role to play in reducing the rate of new abuse and in giving healthcare providers the tools to reduce exposure to opioids to only clearly appropriate patients, so we can also help reduce the new cases of addiction."
On the generic drug market:
"We also need to take steps to make sure the generic drug process isn't being inappropriately gamed to delay competition and disadvantage consumers."
On innovative new therapies:
"Congress gave us a clear mandate to be forward-leaning when it comes to how we'll evaluate safety and efficacy in view of emerging scientific insight and better analytical tools … We need to make sure we're taking steps to foster innovation and regulating areas of promising new technology in ways that don't raise the cost of development or reduce innovation."
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