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Comments to FDA on regulating tobacco products as drugs

January 01, 2016, 2:54 PM
Summary Recommendations:
  • FDA should redefine smoking as a behavior, not a disease, and regulate all tobacco-related and nicotine-delivery products accordingly.
  • FDA should migrate all regulation of tobacco-related and nicotine-delivery products to the Center for Tobacco Products (CTP), with the partial exception that those choosing to be marketed as drugs must also meet the safety, efficacy, research and documentation requirements of the Center for Drug Evaluation and Research (CDER).
  • If implementation of these recommendations is deemed inconsistent with the current text of the FDA tobacco law, action should be taken to amend the law as needed to implement these recommendations for the purposes articulated in this comment to FDA.
Introduction:

The current division of regulatory responsibility between the FDA Center for Tobacco Products (CTP) and the Center for Drug Evaluation and Research (CDER) has fostered a dysfunctional and scientifically unsound regulatory process by which tobacco products regulated by CTP are deemed to have harms, but no potential benefits, and products regulated by CDER are deemed to be unattractive to teens and other non-smokers, safe and effective, no matter how strong the evidence to the contrary.

E-cigarettes and related vapor devices (e-cigs) are most likely responsible for the recent record reductions in both teen and adult smoking in the United States, United Kingdom and Poland. These data are fully consistent with the hypothesis that most, if not all of the major reductions in cigarette use by teens are most likely due to the ever-increasing popularity of e-cigarettes for both current smokers and potential smokers experimenting with tobacco-related products. The fact that this same phenomenon is being observed in three very different countries with very different cultures and regulatory environments further supports the premise that these record reductions are, indeed, due to the skyrocketing use of e-cigs.

Despite this evidence, public health authorities continue to condemn e-cigarettes. FDA has even proposed deeming regulations which, if implemented, would likely eliminate the entire American e-cig industry by imposing requirements that would be physically impossible for any e-cig manufacturer to meet in the context of a pre-market application. This action, if successful, could reverse the recent record reductions in both teen and adult smoking.

The implications of FDA continuing to think of smoking as a disease are substantial. The current situation is one in which CTP thinks only in terms of potential harms of tobacco-related products, and CDER only considers benefits that can be documented by means of randomized clinical trials of individual substances to secure short-term smoking cessation. This leaves no place within FDA to consider benefits such as harm reduction and population health impacts that cannot be addressed by randomized clinical trials. This leaves no place within FDA that can consider benefits of a class of products, rather than one stock keeping unit (SKU) product at a time. Reframing smoking as a behavior, not a disease, and placing all regulation of all tobacco-related products in a single center with the flexibility to design and research and evaluation studies other than randomized clinical trials is a necessary first step if we are to ever enjoy the benefits that THR can offer.

The only partial exception to this rule would be to allow manufacturers who desire to market their nicotine delivery products as drugs to continue do so. Those who chose this option should also be required to meet all CTP requirements relative to marketing, impact on users and non-users, post-market surveillance, etc. This partial exception envisions regulation by CTP with CDER oversight to assure their requirements have been met.

Postal union chief calls for post office banking

December 30, 2015, 4:27 PM

From Heartland

Kevin Kosar, a senior fellow with the R Street Institute, says postal banking is an outdated idea, better left in the history books.

“The postal banking system was established back when private banks did not insure deposits,” Kosar said. “People put their money in the postal bank because it was safe. Congress created the Federal Deposit Insurance Corporation in 1933, and it guarantees customer deposits to private banks. By the time that Congress closed the postal bank, few Americans were using it.”

Make a year-end donation to R Street, get a free gift!

December 29, 2015, 10:54 AM

Get the mug everyone has been talking about. Make a tax-deductible donation to R Street of $50 or more and we’ll send you your choice of these premium drinking vessels.


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China, US signal a cyber policy ‘arms race’

December 28, 2015, 4:00 PM

From SC Magazine

“It’s race to the bottom,” said Nathan Leamer, a policy analyst and the outreach manager for the R Street Institute, in speaking with SCMagazine.com. “We’ve opened the door to other countries racing to pass bad cybersecurity policy.”

 

Kasich signs Ohio TNC bill into law

December 28, 2015, 11:37 AM

Ohio has officially become the 28th state to pass legislation regulating transportation network companies like Uber and Lyft, as Gov. John Kasich signed H.B. 237 into law Dec. 23.

The law establishes the state’s Public Utilities Commission as the statewide regulator of ridesharing services and requires companies to obtain a $5,000 permit to match drivers with potential passengers via smartphone applications. Any limousine and taxicab companies that employ digital apps likewise would be eligible for the same regulatory treatment, although local rules would continue to apply where cars are hailed on the street or ordered via telephone.

During the so-called “Period 1,” when a driver is logged in to a TNC app but not yet matched with a passenger, the law sets minimum bodily injury coverage requirements of $50,000 per person and $100,000 per accident, and a minimum requirement of $25,000 for physical damage liability. From the moment a match has been made until the fare is dropped off at his or her destination, the minimum is $1 million of liability coverage. Coverage must be provided by an insurer rated at least A- by A.M. Best Co. or A by Demotech, and can be obtained either by the driver, by the company or some combination of the two.

The law also requires drivers to submit to criminal, sex-offender and driving history background checks. Drivers are not to be considered employees or agents of TNCs, except where explicitly agreed to by contract.

State capital Columbus performed poorly in R Street’s Ridescore 2015 report, released earlier this month. It received a D grade in TNC friendliness and a C+ overall. Cleveland received an A in TNC friendliness and an overall grade of B.

This work is licensed under a Creative Commons Attribution-NoDerivs 3.0 Unported License.

DMV won’t unleash robocars on CA roads

December 26, 2015, 3:41 PM

From CalWatchdog

Beltway observers hoped to land objections to the California regulations that might reverberate at the federal level in the future. “As currently constructed, these proposed rules work at cross-purposes with operator and passenger safety and with the state’s desire to ensure a livable planet in the future,” wrote R Street’s Ian Adams in a Sacramento Bee op-ed. “But given some thoughtful modifications, they could present a real opportunity for California to lead the world into its next era of transportation.”

Price controls will slow drug innovation

December 24, 2015, 4:33 PM

From San Diego Union-Tribune

Navigating the regulatory regimen is “hugely expensive,” said Ian Adams, Sacramento director of the R Street Institute, a right-of-center think tank. This is “some of the most sophisticated science going on in the world” and researchers don’t know if any investment will pay off.

Season’s greetings from R Street

December 24, 2015, 9:35 AM

All of us here at the R Street Institute would like to wish all of you a Merry Christmas; Happy New Year; a Chag Chanukah Sameach; a Cheerful Maunajiyaras; a Joyous Kwanzaa; a Blissful Rohatsu (also known as Bodhi Day); a Good Winter Solstice; a Festive Festivus; to those who celebrate the Vietnamese New Year of “Tet,” we say “Năm mới dồi dào sức khỏe”; and of course, a Bountiful Canadian Boxing Day, eh?

Every year at this time, we at R Street scatter to the four winds for a week or so, turning off the lights at our home office until the new year begins. New content will be light-to-nonexistent for the next week and a half, but we’ll be back up and running at full speed Jan. 4, 2016.

Until then, I leave you with five of my favorite Christmas songs, of which I hope you haven’t already grown tired.

This work is licensed under a Creative Commons Attribution-NoDerivs 3.0 Unported License.

Gov. Bentley’s beach house blunders

December 23, 2015, 10:29 AM

The 2010 BP oil spill damaged plenty of things along Alabama’s Gulf Coast. The governor’s beach house wasn’t one of them. But here we are, spending BP money to fix it up.

No other governor has been willing to touch the dilapidated eyesore, which was abandoned after damage from Hurricane Danny in 1997. Most have been sufficiently politically astute to realize that renovating a beach house isn’t a sound priority for a cash-strapped state. Nor did any governor want to let the property revert to its prior owners, as required if it isn’t used as the governor’s retreat.

So there it sits and slowly falls apart.

But Gov. Robert Bentley won’t stand for that any longer. It is, in Bentley’s eyes, an absolute embarrassment to all five of the people who actually know where the governor’s beach house is located. After all, what would business and industry think if they knew our governor’s 7500 square foot beach house was in such sorry shape?

Don’t worry. The governor apparently intends the $1.5 to $1.8 million beach house restoration to be an “economic development” initiative. Because nothing entices entrepreneurs to do business in Alabama quite like driving halfway between Gulf Shores and Fort Morgan to visit a beach house in a random subdivision for a state-sponsored vacation.

The renovation looks even more suspect in light of the fact that Bentley just lost his two Gulf Shores vacation homes in his recent divorce. If the optics of reversing course on tax hikes while Bentley’s campaign website still boldly declared “No New Taxes” was bad, this is just plain awful.

In politics, perception matters.

Regardless of the governor’s intentions, the narrative is too easy to construct and simply looks improper. No other governor has seen the residence as a critical economic development tool, but the one who does coincidentally lost his personal vacation properties a month or so before repairs began.

Either the governor simply doesn’t care about public perception anymore or he’s getting terrible counsel. Maybe, it’s both.

The money used for the project comes from one of two $25 million grants BP gave Alabama shortly after the spill. It may not be tax revenue, but it is money designed to ameliorate the impacts of the disaster. It’s shocking that years after the spill we still don’t already have better priorities spelled out for the funds.

Don’t worry. The governor apparently intends the $1.5 to $1.8 million beach house restoration to be an “economic development” initiative. Because nothing entices entrepreneurs to do business in Alabama quite like driving halfway between Gulf Shores and Fort Morgan to visit a beach house in a random subdivision for a state-sponsored vacation.

The renovation looks even more suspect in light of the fact that Bentley just lost his two Gulf Shores vacation homes in his recent divorce. If the optics of reversing course on tax hikes while Bentley’s campaign website still boldly declared “No New Taxes” was bad, this is just plain awful.

In politics, perception matters.

Regardless of the governor’s intentions, the narrative is too easy to construct and simply looks improper. No other governor has seen the residence as a critical economic development tool, but the one who does coincidentally lost his personal vacation properties a month or so before repairs began.

Either the governor simply doesn’t care about public perception anymore or he’s getting terrible counsel. Maybe, it’s both.

The money used for the project comes from one of two $25 million grants BP gave Alabama shortly after the spill. It may not be tax revenue, but it is money designed to ameliorate the impacts of the disaster. It’s shocking that years after the spill we still don’t already have better priorities spelled out for the funds.

ExxonMobil and Sierra Club agreed on climate policy—and kept it secret

December 22, 2015, 4:38 PM

From Bloomberg Business

Over the last seven years, the Obama administration has written rules that govern climate pollution, from tailpipes to smokestacks. Libertarian conservative groups such as the Niskanen Center and R Street have become vocal proponents of a carbon tax. Representative Kevin Cramer, a Republican from oil-rich North Dakota, recently proposed that Congress adopt a carbon tax to replace Obama’s EPA regulation.

DC Gets Top Marks For Uber-Friendly Policies

December 22, 2015, 4:36 PM

From District Source

DC, the top-rated city in 2014, again came out on top with a seven-way tie for “friendliness to vehicle-for-hire transportation” among 50 of the largest U.S. cities, according to a study released by the R Street Institute.

DMV is off track on proposed rules for self-driving cars

December 22, 2015, 10:00 AM

The rise of self-driving vehicles is not the much-feared rise of the machines that some make it out to be. But try explaining that to the California Department of Motor Vehicles.

With direction from the Legislature and under the auspices of protecting consumers from untested products, the state’s automotive-licensing body issued proposed regulations last week intended to control how these new vehicles will hit California’s roads.

The DMV will require a licensed driver to be at the wheel in case of an emergency, a decision that may have been a response to loud calls by some consumer-safety advocates. What that idea has an intuitive appeal, it lacks in both vision and technological understanding.

The safety gains of self-driving cars – as well as the associated savings in health care, litigation and insurance costs – are tied closely to eliminating the leading cause of automotive death and destruction: human drivers.

A study by the National Highway Traffic Safety Administration on the causes of crashes found that driver error is the single largest factor – not vehicle condition, system failure, adverse environmental conditions or roadway design. It’s ironic that, by requiring manufacturers to let drivers take the wheel in an emergency, DMV is effectively requiring them to let drivers make potentially fatal mistakes.

Immediate safety concerns aside, in the wake of the Paris summit on global greenhouse gas emissions, it bears remembering that allowing driver input will have negative long-term environmental repercussions. Even as the state strives to embrace greener vehicles, consumer acceptance of those vehicles will depend on their efficiency.

Vehicle weight is the enemy of vehicle efficiency. The cars we drive today are over-engineered into metal cocoons solely to protect us from ourselves. So long as human drivers remain behind the wheel, heavy and inefficient bodies will be needed. In a very real sense, the DMV’s regulations harm the Brown administration’s efforts to combat climate change.

As currently constructed, these proposed rules work at cross-purposes with operator and passenger safety and with the state’s desire to ensure a livable planet in the future. But given some thoughtful modifications, they could present a real opportunity for California to lead the world into its next era of transportation.

Other states, including neighboring Nevada, also are working on policies for self-driving cars. Should they embrace a less restrictive approach, California risks losing its status as the premier venue for autonomous-vehicle design and development.

The most important consideration in the DMV’s course forward should be its effect on human lives. In 2013, 32,719 Americans perished in traffic crashes. The DMV’s regulations must weigh that human toll against the potential harm of allowing self-driving-vehicle technology to reach to its full potential. At the moment, it is getting that balance flat wrong.

E-cigarette flavors needed to keep vapers from returning to smoking

December 22, 2015, 9:07 AM

WASHINGTON (Dec. 22, 2015) – The variety of flavors available for Electronic Nicotine Delivery Systems (ENDS) like e-cigarettes are a component that keeps many users from returning to traditional tobacco cigarettes, according to a new paper from the R Street Institute.

Author Dr. Edward Anselm, a senior fellow with the R Street Institute, notes that vapers must puff more constantly in order to receive the same levels of nicotine as produced by tobacco cigarettes, which often results in symptoms such as dry mouth and throat. Users report that flavorings help combat those side effects, making them willing to stay with the ENDS products instead of going back to cigarettes.

“Vapers generally report their motivations are harm reduction and smoking cessation, and that they are well-aware that ENDS use is not completely safe,” writes Anselm. “Large-scale surveys and anecdotal evidence show that flavors help users achieve this goal.”

Anselm notes that much more study is needed of the safety of various ENDS flavorings, but little evidence to date supports a conclusion that any specific ENDS flavoring is as unsafe as tobacco smoke. He notes that many flavorings already have been approved by the Food and Drug Administration as food additives, though further research is needed on the effects of burning and inhaling the ingredients.

Finally, Anselm writes that there is no data to show that flavorings attract children to ENDS products who would not otherwise smoke cigarettes. Studies on growing teenage experimentation with e-cigarettes do not account for one-time use or for minors who switch to ENDS products as an attempt to stop smoking cigarettes. Further, many jurisdictions have restricted sales of ENDS products to minors in the same way they have restricted tobacco sales.

“Although additional research is required to resolve many of the public safety questions regarding ENDS, it’s clear from the surveys of smokers who already are using the products to cease an unquestionably deadly habit that the public has made up its mind on the matter,” he writes.

 

The role of flavoring in tobacco harm reduction

December 22, 2015, 9:00 AM

EXECUTIVE SUMMARY

One of the great public health controversies of our time surrounds the debate over what role Electronic Nicotine Delivery Systems (ENDS), of which e-cigarettes are the most common type, might play in tobacco harm reduction. A key element of this discussion concerns the role of flavorings.

Regular users of ENDS declare that flavor is important in their ability to cease smoking. In the absence of flavors to soften the sometimes-harsh taste of nicotine vapor, they are likely to resume smoking cigarettes.

Some public-health officials have expressed concern that certain flavors might attract young people to experiment with nicotine at an early age. Evidence for this thesis has not yet been demonstrated. Concerns about the safety of ENDS and whether ENDS might attract young people to nicotine use threaten to dominate what should be a far broader discussion about how tobacco-harm-reduction strategies could be used to improve public health.

Embracing the 21st century employee

December 21, 2015, 6:57 PM

From The Manhattan Institute

Ian Adams of the R Street Institute agrees, as forcing courts to classify the growing category of independent workers as either employees or independent contractors simply does not work. Courts are currently facing the impossible task of fitting a square peg into two circular holes.

Missouri behind the curve on ridesharing laws, report says

December 21, 2015, 6:53 PM

From St. Louis Business Journal

Missouri is one of about 20 states in the United States that don’t have a some form of statewide legislation creating a regulatory structure for transportation network companies (TNCs) like Uber and Lyft.

That’s according to the R Street Institute, a Washington, D.C.-based free market think tank. The report didn’t include St. Louis’ efforts to pave the way for TNCs.

Letter to President Obama on OMB open-government plan

December 21, 2015, 4:25 PM

Dear Mr. President:

We, the undersigned organizations, are concerned about the failure of the Office of Management and Budget (OMB) to comply fully with a presidential memorandum on transparency and open government. Although OMB released an open-government plan in 2010, it failed to release an open-government plan in 2012 and 2014, and we believe it is on course to fail again. By comparison, every other agency obligated to issue a plan in 2014 ultimately did so. We respectfully request your attention be given to this matter and that you direct OMB to take immediate action to fulfill its obligation.

Your 2009 presidential memorandum on transparency and open government “instructs executive departments and agencies to take specific actions implementing the principles set forth in this memorandum.”[1] OMB issued an implementing open-government directive in accordance with the memorandum; it requires “each agency [to] develop and publish on its Open Government Webpage an Open Government Plan that will describe how it will improve transparency and integrate public participation and collaboration into its activities…. Each agency’s plan shall be updated every two years[2] (emphasis added). The purpose behind the directive, and the plans, is to encourage agencies to articulate how openness helps them fulfill their missions, address public concerns and build openness into the way they operate.

In February 2014, the White House Office of Science and Technology (OSTP) issued guidance[3] to help agencies update their Open Government Plans for 2014. The guidance instructed agencies to incorporate new subjects into their plans, based on the administration’s Open Government National Action Plan, which included 23 new or expanded open government commitments. Despite crystal clear update requirements, the 2014 guidance, the standing White House memorandum, and recommendations[4] and repeated communications[5] from outside stakeholders, OMB did not update its plan and declined to provide a timeline for when an updated plan might be published. More than a year has elapsed since the due date.

Many of us have repeatedly expressed concern over the failure of OMB to meet this obligation in multiple forums. The failure is particularly troubling because OMB is an agency with a central oversight role on information policy, it has responsibility for implementation of this plan, and it often serves as the right hand of the president.

We urge you to direct OMB to take immediate steps to comply with the Open Government Directive and update its Open Government Plan in line with the 2014 guidance.

Thank you for your immediate attention to this matter. If you have any questions, please contact Patrice McDermott, executive director of OpenTheGovernment.org, at pmcdermott@openthegovernment.org, 202.332.6736 or Daniel Schuman, policy director at Demand Progress, at daniel@demandprogress.org.

 

American Association of Law Libraries
American Civil Liberties Union
American Library Association
Association of Research Libraries
American Society of News Editors
Bill of Rights Defense Committee
Citizens for Responsibility and Ethics in Washington (CREW)
Cause of Action Institute
Data Transparency Coalition
Defending Dissent Foundation
Demand Progress
Electronic Privacy Information Center
Essential Information
Global Financial Integrity
National Security Archive
Government Accountability Project
OpenTheGovernment.org
PEN American Center
Project On Government Oversight
Reporters Committee for Freedom of the Press
R Street
Sunlight Foundation

[1] Memorandum for the Heads of Executive Departments and Agencies, Transparency and Open Government, The White House, Jan. 21, 2009: http://1.usa.gov/1SHPCHr.

[2] Memorandum for the Heads of Executive Departments Agencies, Open Government Directive, Office of Management and Budget, Dec. 8, 2009: http://1.usa.gov/1OcRMQZ.

[3] Memorandum for the Heads of Executive Departments Agencies, 2015 Agency Open Government Plans, Memo from Todd Park, Chief Technology Officer, Office of Science and Technology, Feb. 24, 2014: http://1.usa.gov/1lWHDvz.

[4] See, e.g., Crew Submits Open Government Plan Recommendations, May 20, 2014: http://bit.ly/1ZfThQh.

[5] See, e.g., the January 2015 Civil Society Progress Report on the Implementation of the United States’ Second Open Government Partnership National Action Plan, which emphasized that OMB had yet to publish an updated plan since its first version was issued in 2010, and highlighted that civil society organizations had attempted to provided ideas to OMB for an updated plan: http://bit.ly/1O7asyN

DC Legal Hackers’ Le Hackie Awards

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  • Politics of Star Wars panel

    December 21, 2015, 9:00 AM

    Back on Dec. 9, R Street hosted a panel on “The Politics of Star Wars.” Among the topics: was Han Solo the first Uber driver? Was Tatooine a failed state? Are the Sith lords Objectivists? Do Jedis violate the Establishment Clause? And what was tax policy like under the Republic and the Empire?

    Moderated by Benny Johnson of the Independent Journal, the panel featured R Street General Counsel Mike Godwin, Trevor Burrus of the Cato Institute, Emily Zanotti of the American Spectator and special guests Rep. Blake Farenthold, R-Texas, and Grover “Darth” Norquist of Americans for Tax Reform.

    An edited version of the proceedings is posted below:

    This work is licensed under a Creative Commons Attribution-NoDerivs 3.0 Unported License.