The President’s promise to cut FDA red tape – a moment of truth

Technological advances touch every aspect of our lives, often in ways we rarely think about. Today, we live longer, healthier, and better lives because of our access to innovative products that were unimaginable in the recent past.

That’s why it’s critical for regulators to make timely and common-sense decisions. Yet excessive risk-aversion is endemic at federal agencies.

The Food and Drug Administration (FDA) is one of the worst offenders. The agency regulates products that account for more than a trillion dollars annually. The FDA’s obsessive dislike for taking on reasonable risk often comes at the cost of creating unreasonable harm. But the agency is rarely held to account for its inaction.

Following the Obama administration’s record-setting number of regulations, there was hope that the new administration would keep its promise to unshackle businesses, large and small, to develop life-improving products and create American jobs.

In addition to enacting new regulations, the agency frequently stymies progress under existing rules.

Under President Obama, the FDA refused to grant pre-market review to a direct to consumer suite of tests by 23andMe, which would have allowed consumers to test whether they were at increased risk of being diagnosed with diseases such as Parkinson’s and Celiac. In doing so, it denied affordable access to information that, in the case of Parkinson’s, could have led those who were genetically predisposed to seek medical advice in the critical early stages of disease, when treatment could slow the progression of the disease.

In the case of Celiac, patients commonly suffer from crippling symptoms for months or years before making difficult but important dietary changes.

Fortunately, Commissioner Scott Gottlieb’s FDA slightly loosened the rules on genetic testing, but testing companies are still unable to warn patients of the vast majority of diseases out there.

Tobacco Harm Reduction

The agency’s track record is even more troubling when it comes to approving beneficial innovations that could help cigarette smokers quit. The FDA must quickly keep its more than year-old promise “to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers while upholding the agency’s public health mission.” 

Earlier this month, Commissioner Gottlieb reiterated the need to minimize, “addiction to the most harmful products while encouraging innovation in those products that could provide adult smokers access to nicotine without the harmful consequences of combustion.”

Innovative alternatives are critical to public health, especially given that FDA approved nicotine replacement therapies and other currently available medications haven’t done the trick for the approximately 15 percent of American adults who still smoke.

Missed Deadlines

In March of 2017, Philip Morris International (PMI) submitted a pre-marketing tobacco application (PMTA) to the FDA for IQOS, which heats rather than burns tobacco.

Agency-watchers expected the FDA to approve the PMTA by this February, consistent with both the Tobacco Control Act and the agency’s own guidelines. Yet to this day, PMI’s PMTA is gathering dust and seems lost in the process. The approval process for other reduced-risk tobacco product applications drags on with little outward signs of movement.

In Japan, one of a number of countries where IQOS is sold, the non-combustible tobacco product quickly captured 10 percent of the tobacco market, according to the Washington Post.  IQOS seems to deliver exactly what many current smokers want (satisfaction and potentially less harm), and what the FDA has already been calling for (nicotine without combustion).

So, why the delays? FDA, in response to our written query, says it does not comment on pending applications, but that generally, the agency reviews an application as required by law.

An FDA spokesman also told us that, “In the meantime, for smokers who do want to quit, there are proven, FDA-approved smoking cessation prescription medicines, as well as over-the-counter nicotine replacement therapy (NRT) products, such as skin patches, lozenges and gum, to help in the quitting process.”

In other words, despite the agency’s lofty comments about the need for innovation to help smokers who haven’t been able to quit with the help of currently-available FDA-approved medicinal products, there are always FDA-approved medicinal products. As the saying goes, “Insanity is doing the same thing over and over again, but expecting different results.”

In his 100-day action plan, President Trump singled out the slow-moving FDA, promising reforms that “will also include cutting the red tape at the FDA.” The administration must now decide whether to continue to embrace innovation or return to the slow “business-as-usual” model stymieing scientific advances that can save countless lives.

Jeff Stier is a Senior Fellow at the Taxpayers Protection Alliance. Ross Marchand is TPA’s Director of Policy. Ross Marchand is TPA’s Director of Policy.

Originally published at http://dailycaller.com/2018/08/18/presidents-promise-fda-red-tape/

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About Jeff Stier

Jeff Stier is a Senior Fellow at the Consumer Choice Center. Mr. Stier has been a frequent guest on CNBC, and has addressed health policy on CNN, Fox News Channel, MSNBC, as well as network newscasts. He is a guest on over 100 radio shows a year, including on NPR and top-rated major market shows in cities including Boston, Philadelphia, and Sacramento, plus syndicated regional broadcasts. Jeff’s op-eds have been published in top outlets including The Wall Street Journal, The Los Angeles Times, The New York Post, Forbes, The Washington Examiner, and National Review Online.

France’s tobacco branding ban fails to deliver: An alternative approach is needed

CONTACT:

Luca Bertoletti

European Affairs Manager

Consumer Choice Center

 

France’s tobacco branding ban fails to deliver: An alternative approach is needed

Brussels, BE – After more than a year with a branding ban on tobacco products, new numbers published by the French Observatory for Drugs and Addiction reveal that cigarette sales have been cut by less than 0.7 percent.

Luca Bertoletti, European Affairs Manager for the Consumer Choice Center (CCC), said this represents a failure on the part of the French government and should prompt them to turn course.

“After more than a year of plain packaging for tobacco products in France, the policy has failed to significantly reduce smoking rates,” said Luca Bertoletti, European Affairs Manager for the Consumer Choice Center (CCC).

“Removing brands from the packs doesn’t change the behavior of the consumers, but instead promotes sales on the black market. That is troubling for public health advocates and consumers alike.

“If the French government wants to reduce the numbers of smokers it should embrace the use of harm-reducing nicotine products such as e-cigarettes and not ban brands. Brands are a powerful source of information for consumers that help them navigate among different levels of quality and price. Other countries should learn from the failure of plain packaging in France and drop this misguided policy,” said Bertoletti.

***CCC European Affairs Manager Luca Bertoletti is available to speak with accredited media on consumer regulations and consumer choice issues. Please send media inquiries HERE.***

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org.

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About Luca Bertoletti

Luca graduated with a degree in Political Science from the University of Milan in December 2014. He worked as a Business Economics Analyst for the Italian magazine TheFielder in Milan and as Think Thank Coordinator for the Austrian Economics Center in Vienna. He is a fellow of Competere Institute in Rome, a columnist for Atlantico Quotidiano, and he sits on the scientific board of New Direction Italia. He has been featured in the New York Times, Radio RAI, RAI 1, El Economista, The National and many other newspapers.

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DIE WELT: Wir sind Erwachsene, und ja, manchmal treffen wir Entscheidungen, die ungesund sind: Wir trinken Alkohol, essen Tiefkühlpizza, rauchen Zigaretten. Die Antwort kann aber nicht sein, den Verbrauch zu verbieten. Solche Regulierungen widersprechen nicht nur der persönlichen Freiheit.”

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About Bill Wirtz

Bill Wirtz is policy analyst for the Consumer Choice Center, based in Brussels, Belgium. Originally from Luxembourg, his articles have appeared across the world in English, French, German, and Luxembourgish. He is Editor-in-Chief of Speak Freely, the blog of European Students for Liberty, a contributing editor for the Freedom Today Network and a regular contributor for the Foundation for Economic Education (FEE). He blogs regularly on his website in four languages.

Schluss mit der Bevormundung!

DIE WELT: Wir sind Erwachsene, und ja, manchmal treffen wir Entscheidungen, die ungesund sind: Wir trinken Alkohol, essen Tiefkühlpizza, rauchen Zigaretten. Die Antwort kann aber nicht sein, den Verbrauch zu verbieten. Solche Regulierungen widersprechen nicht nur der persönlichen Freiheit.”

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mm

About Bill Wirtz

Bill Wirtz is policy analyst for the Consumer Choice Center, based in Brussels, Belgium. Originally from Luxembourg, his articles have appeared across the world in English, French, German, and Luxembourgish. He is Editor-in-Chief of Speak Freely, the blog of European Students for Liberty, a contributing editor for the Freedom Today Network and a regular contributor for the Foundation for Economic Education (FEE). He blogs regularly on his website in four languages.

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About Fred Roeder

Fred Roder has been working in the field of grassroots activism for over eight years. He is a Health Economist from Germany and has worked in healthcare reform and market access in North America, Europe, and several former Soviet Republics. One of his passions is to analyze how disruptive industries and technologies allow consumers more choice at a lower cost. Fred is very interested in consumer choice and regulatory trends in the following industries: FMCG, Sharing Economy, Airlines. In 2014 he organized a protest in Berlin advocating for competition in the Taxi market. Fred has traveled to 100 countries and is looking forward to visiting the other half of the world’s countries. Among many op-eds and media appearances, he has been published in the Frankfurter Allgemeine Zeitung, Wirtschaftswoche, Die Welt, the BBC, SunTV, ABC Portland News, Montreal Gazette, Handelsblatt, Huffington Post Germany, CityAM. L’Agefi, and The Guardian. Since 2012 he serves as an Associated Researcher at the Montreal Economic Institute.

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About Bill Wirtz

Bill Wirtz is policy analyst for the Consumer Choice Center, based in Brussels, Belgium. Originally from Luxembourg, his articles have appeared across the world in English, French, German, and Luxembourgish. He is Editor-in-Chief of Speak Freely, the blog of European Students for Liberty, a contributing editor for the Freedom Today Network and a regular contributor for the Foundation for Economic Education (FEE). He blogs regularly on his website in four languages.

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About Bill Wirtz

Bill Wirtz is policy analyst for the Consumer Choice Center, based in Brussels, Belgium. Originally from Luxembourg, his articles have appeared across the world in English, French, German, and Luxembourgish. He is Editor-in-Chief of Speak Freely, the blog of European Students for Liberty, a contributing editor for the Freedom Today Network and a regular contributor for the Foundation for Economic Education (FEE). He blogs regularly on his website in four languages.