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# FDA will Stay the Course After Gottlieb Leaves: Opinion
- URL: https://www.fdaweb.com/fda-will-stay-the-course-after-gottlieb-leaves-opinion/
- Published: 2019-03-18T12:00:00.000Z
- Updated: 2026-09-15T01:13:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143631

FDA commissioner **Scott Gottlieb**’s departure next month leaves a full plate of new initiatives and policy directives he spearheaded in the almost two years he was at helm, and it is natural to wonder which will fall through the cracks once he leaves. One prediction has the agency staying on course with the Gottlieb-directed initiatives under the new leadership.

Writing in [opinion piece](https://www.statnews.com/2019/03/18/policy-initiatives-scott-gottlieb-fda-will-remain/?ref=fdaweb.com) posted on *Stat* online, former FDA associate commissioner and now president of health care and regulatory services at APCO Worldwide **Wayne L. Pines** says that the ongoing initiatives are also priorities supported by HHS secretary **Alex Azar**, who oversaw and worked closely with Gottlieb on them. Pines says Azar “will make sure that a new commissioner follows through, perhaps not with the media flair that Gottlieb demonstrated, but with the same substantive goals. On some of these issues, such as reduction of opioid abuse and drug prices, President Trump has also spoken out. And the newly named acting FDA commissioner, **Ned Sharpless**, is an oncologist whose views on tobacco and drug approvals are almost certainly supportive of the initiatives.”

The initiatives are numerous, and Pines noted some of the critical ones. They are

- **Facilitating product approvals**: More open communication between reviewers and the pharmaceutical and medical device industries, enabling them to overcome barriers to approvals more quickly.
- **Generic drug approvals.** Expediting generic approvals and expanding competition in complex drugs to help lower drug prices.
- **Changes to the device approval process.** Gottlieb modernized the device approval process, changing the kinds of devices that must go through certain regulatory reviews. This is not a high-profile issue, but it is important to the future of device innovation.
- **Opioid abuse reduction**
- **E-cigarette and tobacco regulation**

Pines also says that these policies and initiatives will continue because FDA is a collaborative environment and they have been supported with enthusiasm by the staff and are consistent with the agency’s public health mission. “Gottlieb’s departure removes a public voice for some of these policies, but not their vigorous implementation,” Pines writes.