Senate Expected to Vote on Gottlieb Nomination Next Week

by Kelley Drye & Warren LLP
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On May 4, 2017, Senate Majority Leader Mitch McConnell (R-KY) filed cloture on the nomination of Dr. Scott Gottlieb to be the next FDA Commissioner.  A cloture vote to end debate will occur Monday afternoon, with 50 votes needed to advance the nomination.  It will be followed by a final vote on the nomination, which typically occurs after 30 hours of “post-cloture” debate, but it could be shortened by agreement.  Assuming this timing, the final confirmation vote on Dr. Gottlieb’s nomination likely would occur on Tuesday or Wednesday of next week.

As a follow up to our previous post highlighting Dr. Gottlieb’s views on food safety and a science-based approach to consumer communications, here are some additional highlights from the written questions  submitted by Senate HELP Committee Members:

On Marijuana Regulation (Sen. Sanders (I-VT))

Marijuana is currently listed as a Schedule I substance (“drugs with no currently accepted medical use and a high potential for abuse”) under the Controlled Substances Act (CSA)— meaning under federal law, marijuana is considered to be as dangerous as heroin, and more dangerous than opioids. The Drug Enforcement Agency could potentially take action to reschedule marijuana, pending evaluation from the FDA. If marijuana were rescheduled, the FDA would likely wind up with the authority to regulate marijuana and marijuana-derived drugs.

  1. Do you believe that marijuana is properly classified under the CSA?
  2. Do you think FDA should have the authority to regulate marijuana?

A: I am aware that in July 2016, DEA determined, in consultation with HHS, that marijuana continues to meet the criteria for schedule I control under the Controlled Substances Act. I cannot speak to decisions that the DEA might take in the future or the likelihood of FDA regulating marijuana. I do know that FDA is currently involved in supporting scientific research related to medicinal uses of marijuana and its constituents.

On Medications Used By Pregnant and Lactating Women  (Sen. Murray (D-WA)

Currently, there is little knowledge around the safety and efficacy of medications used by pregnant and lactating women, due in large part to a lack of inclusion in clinical trials for medications and treatments. The 21st Century Cures Act created a federal task force to examine some of the issues involved in doing so but much more remains to be done. What steps would you take to increase knowledge regarding safe treatments for pregnant and lactating women?

A: If confirmed, I would look forward to FDA’s participation in the federal task force to examine the inclusion of pregnant and lactating women in clinical trials. As always, my commitment is to seek advances in treatments that are useful to individuals in all stages of life. Understanding the impact of treatments on women who are pregnant and lactating is crucially important. I commit to working with scientific experts at the various agencies and participants of the task force to develop our body of knowledge on safe treatments for this population and help to make sure FDA policies reflect this science.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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