Vapor News and Views – New FDA Head

Vapor News and Views – New FDA Head

scottGottFDA

Scott Gottlieb

March 13, 2017

Vapor News and Views
News and views on vapor tax and regulatory issues from across the United States. The best way to stay up to date with what’s happening in Washington and in your state capitol.

President Trump has nominated Scott Gottlieb to head the Food and Drug Administration (FDA), an agency mired in red tape and bureaucracy. You may recall, Gottlieb was first on my list of options under consideration and there are plenty of reasons to believe this is a good thing for the vapor industry and its consumers. More below!
Paul Blair
Strategic Initiatives Director
Americans for Tax Reform

Who is Dr. Scott Gottlieb and is he on our team?

Nearly all of what you’ll read about Gottlieb relates to his belief that the approval of medicines and medical devices must be sped up. While many of you reading this may have an interest in those topics, I’m going to avoid commentary on the subject (other than to say it’s great) and focus on two issues of relevance to this newsletter.

First, read this 2013 Forbes piece written by Gottlieb, “FDA’s New Tobacco Scheme, and Its Legislative Underpinnings, May Go Up in Smoke.” In the piece, he outlines the two dominant forces at play in the aftermath of the Tobacco Control Act, which brought tobacco products under regulatory control of the FDA. Those two forces were the anti-tobacco crowd (activists) and current and future manufacturers of reduced risk products, like vapor products. In 2013, he concluded that “only one party can win.”

To date, the activists have won. Absent immediate changes, the FDA will oversee the prohibition of vapor products in less than two years. But, if confirmed, Gottlieb can put a stop to that. The question becomes, will he? I’ve got good reasons to believe there’s going to be a culture shift at the agency in a way that’s more helpful than the status quo.

Second, a bit more on his background. Gottlieb served as Deputy Commissioner for Medical and Scientific Affairs at the FDA under President George W. Bush, is a clinical professor at NYU’s School of Medicine and a venture partner at New Enterprise Associates, and is currently a resident fellow at the American Enterprise Institute (AEI).

As I often point out, they’re as big a fans of the concept of harm reduction over at AEI as we are at ATR. A few pieces of commentary from AEI’s Sally Satel:

“What the US Should Learn from the UK’s Wisdom on E-Cigarettes;”
“Congress, Save E-Cigarettes from the FDA;”
“How Vapers Can Help Smokers Quit;”
Where does this leave us? This nomination continues a significant opportunity for advancing a stated goal of the Trump administration: Big League regulatory reform. Gottlieb is a cancer survivor. He isn’t some out-of-touch public health bureaucrat with little to no understanding of the real impact that bureaucracy can have on saving (or destroying) lives. I remain optimistic that this good, very good for the goals of the vapor industry and its millions of consumers who are living healthier lives as a result of market innovations.

New Cole-Bishop Stand Alone Bill Dropped: Broad Coalition Support
Mid last month, House Resolution 1136 was filed by Congressman Tom Cole (R-Okla.). The “FDA Deeming Authority Clarification Act of 2017” accomplishes the same goals as the more well-known “Cole-Bishop Amendment,” the amendment to the House Agriculture Appropriations Bill, which is still under consideration (see: alive) for the FY17 budget debate. (Reminder: the ultimate goal is a modernization of the February 2007 predicate date).

No surprise; the first co-sponsor of the bill was Congressman Sanford Bishop (D-Ga.) and to-date the bill has 14 co-sponsors. It’s been assigned to the House Committee on Energy and Commerce.

There’s a real consensus on this effort. Leaders from the American Vaping Association (AVA), Smoke-Free Alternatives Trade Association (SFATA), Consumer Advocates for Smoke-free Alternatives Association (CASAA), and Vapor Technology Association (VTA) sent a letter to Speaker Paul Ryan and Minority Leader Pelosi urging support for the common sense legislation.

Center for Tobacco Products’ Mitch Zeller Out?
Mitch Zeller, the director of the FDA’s Center for Tobacco Products is not a political appointee. He’s under no obligation to leave the position and could theoretically stick around for a while. But, there are some rumors that he’ll leave this year. He’ll have two choices when confronted with an FDA more supportive of harm reduction than he is: head back to the private sector or change course. My money’s on the big retainer awaiting him at any of the large pharmaceutical companies. Fingers crossed.
Upcoming Event Alert: Tobacco Control in an Era of Vapor Products
This Thursday, March 16th, Americans for Tax Reform is co-hosting an event in Washington, D.C. at the Heritage Foundation, “Rethinking Tobacco Control in an Era of E-Cigarettes and Other Alternatives to Smoking.” I’ll be joined by AEI’s Sally Satel, National Center for Public Policy Research’s Jeff Stier, and Heritage’s Daren Bakst.
Details: “This expert panel will discuss [smoking] alternatives, the latest research, the current harmful meddling of the federal government, and a new approach to tobacco policy, “tobacco harm reduction,” that recognizes that reducing the harm from the delivery of nicotine is not an all-or-nothing proposition.”

For those of you who live in real America and are unable to attend the event in person, that event can be viewed at 12:00PM EST on Heritage’s website. More info here.

 

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Paul Blair | Americans for Tax Reform | 202-785-0266 | pblair@atr.org | www.atr.org