- The FDA released new guidelines this week in regards to generic drug review process
- One focuses on applications themselves and the other the FDA's practices.
- FDA commissioner Scott Gottlieb hopes to get generic drugs to market in just eight to ten months, versus the average of four years in the past.
- Gottlieb will be a featured speaker at CNBC's new healthcare conference, Healthy Returns, on March 28 in New York City.
The FDA believes creating a more efficient generic drug review process in 2018 will enhance competition and promote continued innovation in the market.
New guidelines released this week by the administration aims to get generic drugs to market in just eight to ten months, versus the average of four years in the past, FDA commissioner Dr. Scott Gottlieb told CNBC Sqwawk Box Thursday morning.
"The goal is to cut down on what we call multiple cycles of review," Dr. Gottlieb said. "The reason why generic drugs were delayed in getting to the market is many times the application would undergo multiple cycles of review, up to four on average."
The new guidelines come in the form of two documents released Wednesday: the first focuses on generic drug applications.
"A lot of the issues that come up in the generic drug approval process aren't issues with the application itself, the way the studies were run, but more related to the manufacturing process," Gottlieb said.
The second document addresses the FDA's process in approving applications.
"The other guidance that we put out is basically guidance to the FDA describing a more efficient, streamline process for reviewing those applications and trying to get them approved on the first cycle," Dr. Gottlieb said.
More than 1,000 generic drugs were approved by the FDA in 2017 – a record, and FDA is already on pace to approve a higher number in 2018.Gottlieb believes these new guidelines are essential to accomplishing that task.
Some critics argue the FDA is lowering standards for approval when it comes to new branded drugs; Gottlieb argues that is not the case.
"I think we can make the process more efficient and see more robust innovation come into the market, and also get a higher degree of assurance around safety and effectiveness if we're doing smart things and we're modernizing the review process. And that's the kind of thing we're trying to do," Gottlieb said.