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FDA Commissioner Scott Gottlieb will leave open multiple ambitious projects concerning the agency's oversight of consumer health product industries when he resigns in around a month.Gottlieb claimed a higher profile than most previous FDA commissioners with frequent posts of agency news via his Twitter account and by adding his remarks to many agency announcements to regulated industries and to consumers. In his nearly two years in the post, he also had a more central role in FDA initiatives in areas such as keeping unsafe products labeled as dietary supplements off the market and explaining why hemp and cannabidiol are available in food and supplements even though FDA considers the products noncompliant as dietary ingredients.

Since Gottlieb, a physician and a venture capital investor, became commissioner in May 2017, FDA also has met remaining deadlines on OTC sunscreen monograph rulemakings and guidances imposed by the 2014 Sunscreen Innovation Act. Still, the proposed final sunscreen monograph that FDA's Center for Drug Evaluation and Research published in February, its latest regulatory action required by the act, leaves the agency and the industry with years of work ahead to determine whether the majority of sunscreen ingredients used in products marketed in the US will remain available. (Also see "'Data Gaps' Keep 12 Ingredients Off FDA's Proposed OTC Sunscreen Monograph" - HBW Insight, 21 Feb, 2019.)

Gottlieb, who announced his pending resignation in a Twitter post on March 5, also gave a higher profile to FDA's oversight of the e-cigarette, or electric nicotine delivery device (END), market. He has been consistent with criticism of some firms for marketing products, notably flavored liquid nicotine, to young consumers and adding drug ingredients to nicotine. (Also see "Sales of Drug-Spiked Nicotine Could Sink E-Cigarettes' Smoking Cessation Chances" - HBW Insight, 11 Oct, 2018.)


Gottlieb Speaking


On the other hand, Gottlieb's FDA also published draft guidances on non-clinical trials in 2018 and more recently on clinical trials needed to support new drug applications for Rx and OTC smoking cessation and related indications. The commissioner also has made ENDs or other novel products the centerpiece of encouragement to firms to sponsor NDAs for making additional products available with a smoking cessation indication. ( (Also see "FDA Helps E-Cigarettes Navigate NDA Process With Nonclinical Tests Guidance" - Pink Sheet, 3 Aug, 2018.))

In his resignation tweet, Gottlieb didn’t identify disagreements with the White House as prompting his decision. Other executive branch appointments by President Trump have resigned amid ethics scandals and other turmoil, including the head of the Department of Health and Human Services when Gottlieb took the FDA helm, Tom Price. ( (Also see "HHS Leadership Upheaval Could Delay Initiatives Impacting Biopharma" - Pink Sheet, 29 Sep, 2017.))

Instead, Gottlieb, who had pharma industry ties as a consultan tbefore taking the FDA helm, stated that "nothing could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children."

FDA Experience Before Taking Helm

Gottlieb came to the commissioner's post with a good grasp of FDA's priorities for improving its oversight of the OTC drug and supplement industries. He had been a senior advisor to former FDA Commissioner Mark McClellan from 2003-2004 before moving with him to the Centers for Medicare and Medicaid Services as senior advisor. He returned to FDA in 2005 as deputy commissioner for medical and scientific affairs for a year and half.

Gottlieb "was a commissioner who understood the pivotal role of the commissioner to move policy in all areas that FDA regulates." – CRN President and CEO Steve Mister

During his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee in April 2017, he said FDA's OTC monograph program had needed "immediate action" 10 years earlier when he worked on McClellan's staff.  (Also see "OTC Monograph Woes No Surprise To FDA Commissioner Nominee Gottlieb" - HBW Insight, 5 Apr, 2017.)

However, a proposal significantly streamlining FDA's process for adding OTC monograph ingredients was not added to 2018 legislation that agency officials and industry stakeholders recognized as its strongest chance for passing, the bill reauthorizing FDA's drug user fee programs Congress passed. Since then, the proposal has not found support in the Senate due to opposition to market exclusivity that would be granted for some approved monograph changes. The House has passed standalone two monograph overhaul bills and another unrelated bill that also included the monograph legislation, that allow 18-month market exclusivity for some monograph additions, including one in the first week of the current session. (Also see "House Maintains Momentum For OTC Monograph Reform, Senate Regard TBD" - HBW Insight, 9 Jan, 2019.)

Kratom An Early Target

In addition to steering FDA toward a decision on hemp and CBD in supplements and a revamp of its VMS industry oversight, Gottlieb pointed the agency toward ridding the US market for products containing the herb kratom. From testing two compounds in kratom – mitragynine and 7-hydroxymitragynine – that the Drug Enforcement Administration has proposed to schedule as controlled substances, FDA in late 2017 reported that the chemical structures of the 25 most prevalent compounds in the herb all share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

But DEA has yet to decide whether to schedule the botanical and the kratom industry contests FDA's findings. The industry contends kratom is a safe dietary ingredient that has been used in other parts of the word for centuries and was prevalent in the US before the October 1994 grandfather date for an ingredient to be eligible for use in supplements without first being notified to the agency with proof of reasonable expectation of safety for its intended use. ( (Also see "Kratom Advocates Urge Industry Compliance, FDA And DEA Compassion" - HBW Insight, 7 Mar, 2018.))

The kratom question, CRN's Mister said, is entirely DEA's. CRN agrees with FDA that kratom is not allowed as a dietary ingredient in the US. "That's just an enforcement matter," he said.

The commissioner's support for a monograph overhaul was noted by the Consumer Healthcare Products Association. "Commissioner Gottlieb has been a vocal advocate for ensuring consumer access to safe and reliable self-care options including over-the-counter medicines and dietary supplements. His tenure at FDA has been marked by tremendous progress on modernizing the regulatory framework for OTC medicines and beginning similar work for dietary supplements," said CHPA President and CEO Scott Melville in a statement.

FDA's second high-priority OTC regulatory issue reached a milestone under Gottlieb with a July 2018 draft guidance discussing FDA's approach for making more Rx drugs available OTC, particularly for chronic conditions, including tapping into digital media and other tools to help show that consumers can assess whether an OTC drug is appropriate for them and can use the product safely. CHPA, however, said in comments that the draft raised more questions than it answered, heightening the need for a rulemaking to clarify how sponsors can satisfy the agency's standards. (Also see "FDA OTC Switch Guidance Omits Some Turns As Approval Roadmap, CHPA Says" - HBW Insight, 19 Sep, 2018.)

Existing FDA regulations require that a consumer must be able to make this evaluation using only information in an OTC product's Drug Facts label. However, difficulty in showing to FDA's and its advisors' satisfaction that consumers can accurately self-select and safely use a certain drug has prevented approvals for some switch proposals.  (Also see "FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure" - Pink Sheet, 7 Nov, 2013.)

Fostering Momentum On VMS Industry Oversight

Gottlieb's approach to improving the agency's oversight of vitamin, mineral and supplement (VMS) product manufacturing and marketing came to a head recently when he announced that FDA will consider conducting rulemakings or ask members of Congress for legislation to strengthen its authority over the market. A five-point plan he outlined in February to implement "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years" includes steps to ensure its regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, particularly finalizing new dietary ingredient notifications guidance, fostering submissions of the notifications and requiring VMS products sold in the US to register on an FDA list. (Also see "Modernizing FDA's Supplement Industry Regulation Mapped Out In Five-Point Plan" - HBW Insight, 11 Feb, 2019.)

That's a lot of proposed changes, says Natural Products Association President and CEO Daniel Fabricant. "We want to partner with government to see some of it through," he said.

However, talking about changes and proposing ideas aren't the measure of making an impact, Fabricant added. "It's the actions that last."

And particularly for changes in FDA authorities possible only through legislation from Congress, suggesting ideas doesn't go far.

"Given the current legislative environment, if they're looking at Congress adding more regulatory authority at FDA, good luck with that," he said.

Gottlieb came to the commissioner's post with a good grasp of FDA's priorities for improving its oversight of the OTC drug and supplement industries after working as a senior advisor to former FDA Commissioner Mark McClellan from 2003-2004 and returning to the agency in 2005 for an 18-month stint as deputy commissioner for medical and scientific affairs.

At the Council for Responsible Nutrition, President and CEO Steve Mister sees Gottlieb's tenure as generating momentum for FDA to improve its VMS market oversight. "We have really seen the Office of Dietary Supplement Programs get a strong footing and move forward," Mister said.

While Gottlieb called out noncompliant supplement products as threatening public health, he also noted the value of VMS products and worked with the industry to help itself, Mister added. "This was a commissioner who recognized the importance of collaborating with the industry rather than being adversarial to it at all times."

The higher profile Gottlieb took in heading FDA, Mister said, could be a model for other commissioners to heighten their role in protecting public health and improving health care. "He was a commissioner who understood the pivotal role of the commissioner to move policy in all areas that FDA regulates."

Taking On CBD Questions

Also recently, Gottlieb acknowledged a potential door for hemp, CBD or other cannabis-derived compounds to be allowed in supplements or food after Congress included a provision allowing hemp production and sales in the five-year reauthorization of US Department of Agriculture programs. Noting that FDA has authority to issue a regulation allowing use of a pharmaceutical ingredient in a food or a supplement, in December he said FDA would schedule a public meeting for comments on lawful pathways for marketing products containing cannabis or cannabis-derived compounds and on the agency's existing regulatory strategy. (Also see "FDA To Consider Regulatory Shift Making Cannabis Ingredients Officially Eligible For Use In Dietary Supplements" - HBW Insight, 28 Dec, 2018.)

More recently, in a Feb. 27 House Appropriations subcommittee hearing, Gottlieb said he would appoint a working group following a public meeting, which will be in April, to guide the agency's decisions. He explained, though, that if an FDA rulemaking would draw out implanting a changes over multiple years, he would return to Congress to discuss legislation granting the agency authority to make changes. (Also see "House Appropriators Stoke Flames For FDA Regulation On CBD In Supplements" - HBW Insight, 1 Mar, 2019.)

Potential changes for FDA's policy on hemp and CBD use in food and supplements already were coming to the fore before Congress included a hemp provision in the latest farm bill. Approval of a cannabidiol-based drug in June 2018 made the question more urgent because FDA has been allowing sales of hemp- and CBD-containing food and supplements that are marketed with compliant claims. (Also see "CBD Drug Approval Not A Sign FDA Will Allow Its Use In Supplements" - HBW Insight, 26 Jun, 2018.)

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