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# Lawyers Predict Gottlieb ‘Imminent Confirmation’
- URL: https://www.fdaweb.com/lawyers-predict-gottlieb-imminent-confirmation/
- Published: 2017-04-14T12:00:00.000Z
- Updated: 2026-09-14T22:17:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138449

An Epstein Becker & Green [client alert](http://www.ebglaw.com/news/trump-gottlieb-and-the-cures-act-what-pharmaceutical-manufacturers-need-to-know/?ref=fdaweb.com) predicts an “imminent confirmation” of **Scott Gottlieb** to be the next FDA commissioner, which should be a win for industry based on his support of “flexible systemic approaches to shorten review timelines and bring more products to market.” Gottleib’s stance fares well for 21st Century Cures Act-related initiatives, “such as the use of novel clinical trial designs and alternative sources of data, which are meant to reduce drug approval timelines and provide additional data for FDA review,” the alert says.

A major obstacle for Gottlieb in implementing the Cures Act will likely be the Trump administration’s “two for one” [executive order](http://www.ebglaw.com/news/trump-gottlieb-and-the-cures-act-what-pharmaceutical-manufacturers-need-to-know/?ref=fdaweb.com#%5Fftn9) (EO) requiring that any “significant regulatory action” that an agency wants to implement — including, in some instances, guidance documents — must be offset by eliminating two other regulations, according to the alert. “As the majority of the Cures Act’s provisions call for guidance documents to be proposed, the EO could present a significant challenge to the effective implementation of critical pieces of the Cures Act,” it says.

“There are three ways FDA may circumvent this restriction in connection with the Cures Act,” the alert continues. “First, any regulations promulgated or guidance issued under the Cures Act would be exempt from the ‘two for one’ requirement under Section 2(b) of the EO to the extent that they are ‘required by law.’ Second, FDA could argue that the regulation or guidance is deregulatory and, thus, does not trigger the requirement in accordance with the EO’s implementing guidance from the Office of Management and Budgets. However, in order to qualify as deregulatory, the action must provide cost savings for all affected parties. Third, FDA can consult with its Office of Information and Regulatory Affairs Desk Officer regarding significant guidance on a case-by-case basis to determine if the EO applies. However, if this ‘two for one’ EO proves applicable to the Cures Act and Dr. Gottlieb is confirmed, he may face a difficult path trying to implement key provisions of the Cures Act and other initiatives consistent with his policy positions.”

  
Additionally, another hurdle will be adequate resources. “Whether FDA will have the necessary budget to implement these provisions of the Cures Act is unclear based upon the budget proposals from the White House that limit FDA funding, and the looming reauthorization of the prescription drug user fees,” the alert says. “Therefore, despite the bipartisan support behind passing the Cures Act, FDA may still lack the resources to effectively support all of the initiatives required under the Cures Act.”