The end of the fiscal year came and went and there was virtually no talk of deficits and debt. But we asked you what you thought in our poll: “As the end of the fiscal year, and a potential government shutdown approaches, what should Congress focus on?” You voted and the message was loud and clear. “Cutting Spending” received 60% of votes, followed by: “Reducing Tariffs” – 40%; “Cutting Taxes” – 16%; and “Reforming Healthcare” – 4%. Ok, Congress, you know what you need to do. The next poll is up and running. Carefully consider our new question, “What should the FDA’s #1 Priority Be?” Here are your options: 1. Streamlining the medication approval process; 2. Bringing life-saving harm reduction products to the market quickly; 3. Revising guidelines on which foods are “healthy”; or 4. Other. Remember, your say matters. So, vote!
Reforming the FDA: Saving Money, Saving Lives
It was an exciting week with the release of our report, Reforming the FDA: Saving Money, Saving Lives. From drug approvals to tobacco harm reduction to food regulation, the report puts a microscope on the Food and Drug Administration (FDA) and identifies much-needed reforms that would make the FDA work for all Americans. The $5 billion agency has increasingly stymied life-saving medications and products that could change millions of lives for the better.
Tobacco Harm Reduction
Tobacco harm reduction is in the national spotlight as people are getting sick from black-market vape liquids every day. The FDA has an opportunity to help stop this problem by approving e-cigarettes and not requiring a long and slow process to get new products approved. Already, the new heat-not-burn technology of IQOS has been approved for sale by the FDA and has the potential to save millions of lives. Millions of consumers around the world are quitting traditional cigarettes with IQOS. The process was supposed to take 180 days (as outlined by FDA regulations) but instead took more than 700 days to approve.
Though these products ultimately passed muster with the FDA, the same cannot be said for e-cigarettes. The 2016 Deeming Rule stipulated that, as “tobacco products,” devices such as e-cigarettes were to be regulated similarly to cigarettes, cigars, and cigarillos. Given the benefits of vapes in lowering smokers’ exposure to toxins, the agency needs to consider a lighter regulatory approach. Rescinding the Deeming Rule would exempt these products from a costly premarket approval process, allowing for fewer barriers to entry for life-saving products. The FDA should allow new product variants with lower nicotine and/or tobacco to be covered by the same application as existing products. In addition, the FDA should audit existing procedures to ensure that user fees charged to producers align with actual product evaluation costs. Finally, the FDA should commit to automatically approving a product if it does not meet the 180-day evaluation deadline stipulated in 21 USC § 387j(c). This policy change
would be a powerful incentive for the agency to evaluate products in a reasonable, lawful timeframe.
Drug Approval
Drug approvals are probably the most visible duty of the FDA. It currently takes 12 years and $2 billion for a new drug to be approved. And, as you can imagine, many are not approved. The agency’s labyrinth drug approval process regularly results in promising drugs being rejected if the FDA’s exact statistical specifications are not met. The FDA requires a 95 percent efficacy rate of a medication for it to be approved. Drug manufacturer Dendreon found this out the hard way in 2006 when they submitted mountains of statistical evidence to the FDA attesting to the effectiveness of their medication Provenge in fighting prostate cancer. Dendreon was able to show in their clinical trials that mortality rates declined once patients started taking Provenge. The study’s authors found more than a 90 percent likelihood that the finding was not due to chance. But, despite this powerful evidence, the FDA wasn’t moved because it didn’t reach the 95 percent threshold. The manufacturer had to go back
to the drawing board and produce more expensive, time-consuming studies to satisfy the agency’s strict standard. Four years and more than 100,000 prostate cancer deaths later, the FDA finally approved the medication. This saga highlights an increasingly complex process that results in 9 out of 10 “experimental” medications never reaching the market.
The FDA should reevaluate statistical standards for medications’ efficacy. In 2010 draft guidance, the agency acknowledged the benefit of alternative statistical approaches, but this guidance was never finalized. The FDA should advance this guidance and consider clinical trial results that consistently approach the 95 percent confidence interval even if they do not consistently meet that threshold.
Food Regulation
The FDA has long insisted that products are not healthy if they contain “too much” of one ingredient or type of molecule (i.e. saturated fats), regardless of the presence of other ingredients which may be healthy for the consumer. As a result, the FDA has expended critical resources targeting companies that reasonably market their products as “healthy,” at the expense of more critical agency missions such as food safety inspections. The agency should clarify that “healthiness” can only be assessed comprehensively via all of a product's ingredients and elements, rather than the presence of a single unhealthy addition. Finally, the agency should consider expunging listings such as cholesterol and added sugars from Nutrition Facts guidelines, as these items are not associated with long-run, adverse health issues.
Blogs:
** Monday: Taxpayers and Consumers Need Beware of Costly, ‘Green’ Trojan Horses ([link removed])
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** Tuesday: FDA Must Allow, Not Thwart, Genetic Testing Revolution ([link removed])
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** Tuesday: Watchdog Group Praises Appeals Court Ruling on Open Internet ([link removed])
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** Wednesday: Taxpayer Watchdog Releases New Report on FDA Reform ([link removed])
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** Thursday: Reforming the FDA: Saving Money, Saving Lives ([link removed])
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** Friday: Watchdog Condemns Bill that Would Weaken Key Intellectual Property Protections ([link removed])
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Media:
September 30, 2019: The Washington Examiner (Washington, D.C.) ran TPA’s op-ed, “Ordinary Americans finally win in court against USPS.”
October 2, 2019: I appeared on KRC Radio (Cincinnati, Ohio) to talk about vaping, the Green New Deal, and the United States Postal Service.
October 3, 2019: I appeared on WBOB Radio (600 AM AND 101 FM; Jacksonville, Fla.) to talk about tariffs, trade, and the economy.
October 3, 2019: The Tennessean (Nashville, Tenn.) ran TPA’s op-ed, “Tennessee will lead the way in Healthcare Reform if block grant is approved.”
October 3, 2019: WBFF (Fox, Baltimore) interviewed me about FDA reform.
** October 3, 2019: Townhall ran TPA’s op-ed, “New Watchdog Report Paves Way for FDA Reform.”
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Have a great weekend, and as always, thanks for your continued support.
Best,
David Williams
President
Taxpayers Protection Alliance
1401 K Street, NW
Suite 502
Washington, D.C. xxxxxx
www.protectingtaxpayers.org ([link removed])
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