Scott Gottlieb Takes the Helm of the FDA

Earlier this week, Dr. Scott Gottlieb was sworn-in as the new FDA commissioner. One of the first things on his regulatory agenda is to address drug pricing – a hot topic in the US pharmaceutical industry today.

“For one thing, too many consumers are priced out of the medicines they need,” said Gottlieb in his first speech as commissioner. “Now, 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.”

Gottlieb has long been a proponent of faster drug approvals for generics, so his comments were likely no surprise to those in the industry. But he also hinted that the agency will be cracking down on generic drugmakers and pharmaceutical companies who purposely manipulate the system to reduce competition by delaying the entry of generics onto the market. The new FDA commissioner said, “I hope to have much more to say on this topic in the coming weeks.”

He also aims to provide more support for regulatory approval of biosimilar, which have seen far less approvals in the US compared to Europe. To date, only five biosimilars are approved for use in the US, and without further biosimilar competition, these biologics are only slightly less costly compared to their branded counterparts.

Gottlieb also touched on the issue of opioid abuse, which has grown in the US and other developed countries in recent years. While he admits that the agency has made strides towards addressing the problem, the fact that the issue has continued to grow suggests that these steps have be insufficient.

“But unquestionably, our greatest immediate challenge is the problem of opioid abuse,” said Gottlieb. “This is a public health crisis of staggering human and economic proportion.

“The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in giving health care providers the tools to reduce exposure to opioids to only clearly appropriate patients, so we can also help reduce the new cases of addiction. Addressing this tragedy is going to be one of my highest initial priorities.”

Gottlieb takes over from former FDA Commisioner, Dr. Robert Califf, who served in this position for just under one year. President Trump nominated Gottlieb for the position in March of this year, and compared to the President’s other potential picks for the position, Gottlieb was considered to be the least-controversial.