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	<title>deregulation &#8211; The Beacon</title>
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		<title>Rush Limbaugh on Air</title>
		<link>https://blog.independent.org/2021/02/23/rush-limbaugh-on-air/</link>
		
		<dc:creator><![CDATA[David J. Theroux]]></dc:creator>
		<pubDate>Tue, 23 Feb 2021 23:30:44 +0000</pubDate>
				<category><![CDATA[The Beacon]]></category>
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		<guid isPermaLink="false">https://blog.independent.org/?p=50956</guid>

					<description><![CDATA[<p>After failing at numerous radio jobs in the 1970s, in which he tried out various styles, including his first broadcast gig at KUDL in Kansas City, the famed talk-radio giant Rush H. Limbaugh III (1951–2021) began his real radio-broadcast career when he hosted a daytime talk show that innovatively mixed conservative politics and humorous...<br /><a href="https://blog.independent.org/2021/02/23/rush-limbaugh-on-air/">Read More &#187;</a></p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2021/02/23/rush-limbaugh-on-air/">Rush Limbaugh on Air</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>After failing at numerous radio jobs in the 1970s, in which he tried out various styles, including his first broadcast gig at KUDL in Kansas City, the famed talk-radio giant Rush H. Limbaugh III (1951–2021) began his real radio-broadcast career when he hosted a daytime talk show that innovatively mixed conservative politics and humorous entertainment from 1984 to 1988 at the KFBK-AM station in Sacramento, California. <a href="https://www.forbes.com/sites/dawnchmielewski/2021/02/17/rush-limbaugh-led-a-radio-revolution-that-earned-him-more-than-1-billion/?sh=34aba26246de">According to <em>Forbes</em>’ Dawn Chmielewski</a>,</p>
<p><span id="more-50956"></span></p>
<blockquote><p>Limbaugh rose to No. 1 in the market, doubling the size of his audience in just a year. . . . When a radio consultant told his friend Ed McLaughlin about Limbaugh’s popularity there, the ABC Radio Networks President traveled to Sacramento to hear him firsthand. . . . McLaughlin, who credited Limbaugh with rescuing AM radio from oblivion in a 1994 <em>Forbes</em> profile, recruited the local host to New York. He debuted a two-hour talk show on WABC in August 1988 that they soon began syndicating across the country. At the time, AM radio was facing an existential crisis. Listeners had gravitated to FM for music, leaving AM radio in search of a winning programming format. Talk filled the silence.</p></blockquote>
<p>Limbaugh’s program in Sacramento that launched his nationally syndicated “The Rush Limbaugh Show” was only possible after the FCC’s 1987 repeal of the suffocating Fairness Doctrine (created in 1949) had opened up AM radio to free speech and new programming competition. For over three decades, Limbaugh’s program was by far the most popular radio show in America, airing on <a href="https://www.forbes.com/sites/dawnchmielewski/2021/02/17/rush-limbaugh-led-a-radio-revolution-that-earned-him-more-than-1-billion/?sh=34aba26246de">more than 650 stations nationwide</a> across the Premiere Radio Networks with a weekly audience of 25 million, and on May 7, 2020, <a href="https://news.iheart.com/featured/rush-limbaugh/content/2020-05-07-pn-rush-limbaugh-eib-audience-models-project-43-million-listeners/">Limbaugh announced on air</a> that Premiere had calculated an audience that day of 43 million people with an average listening time of two hours and 28 minutes. But throughout his career, he never lost affection for his successful radio roots in the Sacramento area, regularly returning to the area and often on his show humorously singling out comments “For those of you in Rio Linda.”</p>
<p>We had the memorable opportunity to work with Rush Limbaugh on two pivotal occasions.</p>
<p>The first occurred in the mid-1980s, when I was in the process of producing the paperback edition of a book on the growing problem of affordable housing in California, <a href="https://www.independent.org/pdf/book_covers/resolving_housing_crisis.pdf"><em>Resolving the Housing Crisis: Government Policy, Decontrol and the Public Interest</em></a>. Edited by the late, renowned economist <a href="https://www.independent.org/centers/johnson.asp">M. Bruce Johnson</a> (U.C. Santa Barbara), who would become the founding Research Director at the <a href="https://www.independent.org/">Independent Institute</a>, the book assembled the most comprehensive-ever critical analysis of government housing and land-use controls restricting the supply of housing and new construction and creating the unaffordable housing tragedy that has only greatly worsened today, including contributing to the massive problem of homelessness.</p>
<p>The acclaimed Clemson U. economist <a href="https://www.clemson.edu/business/about/profiles/hazlett">Thomas W. Hazlett</a> (Ph.D., UCLA) at the time was a new assistant professor at the University of California at Davis (U.C. Davis). Tom had contributed the superb Chapter 10 in <em>Resolving the Housing Crisis</em>, “Rent Controls and the Housing Crisis,” and he had further assisted Bruce in completing details for his Introduction to the book.*</p>
<p>Bruce and I were planning to be in Sacramento in spring of 1984 for a one-day conference I had organized on the housing crisis in California with the California Chamber of Commerce and other groups. Bruce was to be a keynote speaker along with the housing and land-use expert <a href="https://www.independent.org/aboutus/person_detail.asp?id=781">Ward A. Connerly</a>, and all attendees would receive a free copy of the book.</p>
<p>Tom had first met Rush Limbaugh at an event at U.C. Davis at which former U.N. Ambassador Jeane D. Kirkpatrick (1926-2006) spoke, and Tom and Rush became good friends. As a result, Tom helped us arrange for Bruce and me to visit with Rush while we were in town for the housing conference to discuss the book’s findings in the KFBK studio.</p>
<p>We had already arranged for Bruce to be interviewed about the book on numerous radio programs, but none of the show hosts understood the housing issue and were quite clueless of government’s culpability in creating the problem. But in visiting with Rush, we found that just as Tom had promised, he had clearly done his homework on the book and understood its findings, interviewing Bruce at considerable detail for an entire hour.</p>
<p>I recall Bruce’s delight, excitement, and amazement with the interview by this guy who neither of us had ever heard of but who, unlike other radio hosts, fully understood what Bruce was saying and the central need for deregulation, free markets and private property rights.</p>
<p>The second time we connected directly with Rush was when we had published the first edition of the Independent Institute’s book,<em> Hot Talk, Cold Science: Global Warming’s Unfinished Debate</em> by our Research Fellow, the late <a href="https://www.independent.org/aboutus/person_detail.asp?id=496">S. Fred Singer</a>, and featuring a foreword by <a href="https://www.independent.org/aboutus/person_detail.asp?id=309">Frederick Seitz</a>, former President of the National Academy of Sciences.</p>
<p>Rush enthusiastically interviewed Fred, who at the time was in Bonn, Germany, having addressed the Austrian Parliament in Vienna a few days earlier, and Rush subsequently <a href="https://www.thelimbaughletter.com/thelimbaughletter/february_2019/MobilePagedArticle.action?articleId=1459904&amp;lm=1613792011000#articleId1459904">published the interview in <em>The</em> <em>Limbaugh Letter</em></a> (December 1997):</p>
<blockquote><p>Fasten your seatbelts—you are about to get some real science from one of the foremost experts on global climate change. In fact, Dr. Singer devised the basic instrument for measuring stratospheric ozone. He was somewhat reluctant to discuss the political aspects of the global warming debate—though I tried. Still, as a scientist, he backed me up . . . and confirmed things I’ve been saying for years. . . .</p></blockquote>
<p>The book became a major seller with extensive <a href="https://www.independent.org/store/book.asp?id=42#t-5">media coverage featuring Fred</a>, and was instrumental in redefining and redirecting public climate debate away from unscientific alarmism, leading up to the U.S.’s refusal to ratify the deeply flawed 1992 Kyoto Protocol to the United Nations Framework Convention on Climate Change.</p>
<p>Incidentally, we have just released <a href="https://www.independent.org/store/book.asp?id=136"><em>Hot Talk, Cold Science</em> in a Third Revised and Expanded Edition</a> (twice the size of the previous editions in 1997 and 1999), completed by Fred before his death in 2020 and co-authored with the climatologists <a href="https://www.independent.org/aboutus/person_detail.asp?id=949">David R. Legates</a> (U. of Delaware) and <a href="https://www.independent.org/aboutus/person_detail.asp?id=4130">Anthony R. Lupo</a> (U. of Missouri), and with a new foreword by the eminent physicist <a href="https://www.independent.org/aboutus/person_detail.asp?id=4087">William Happer</a> (Princeton U.)</p>
<p>We will forever be grateful for the very kind and generous assistance of the late Rush Limbaugh.</p>
<p><em>Requiem æternam dona ei, Domine. Et lux perpetua luceat eis.</em></p>
<p>* * * * * * * *</p>
<p>*Other distinguished scholars who were contributing authors to <em>Resolving the Housing Crisis</em> include Peter Colwell (U. of Illinois), Carl Dahlman (U. of Wisconsin), Robert Ellickson (Yale U.), Bernard Frieden (MIT), Norman Karlin (Southwestern U. Law), James Kau (U. of Georgia), Richard Muth (Stanford U.), Roger Pilon (U.S. Office of Personal Management), Judith Robert (U. of Michigan), Bernard Siegan (U. of San Diego), and Robert Weintraub (U.S. Joint Economic Committee), as well as Stephen DeCanio, H. E. Frech III, Alan Gin, Lloyd Mercer, Douglas Morgan, and Jon Sonstelie (all from U.C. Santa Barbara).</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2021/02/23/rush-limbaugh-on-air/">Rush Limbaugh on Air</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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		<title>Trump Administration Finds That Deregulation Is Getting Harder and Harder</title>
		<link>https://blog.independent.org/2020/01/28/trump-administration-finds-that-deregulation-is-getting-harder-and-harder/</link>
		
		<dc:creator><![CDATA[Craig Eyermann]]></dc:creator>
		<pubDate>Tue, 28 Jan 2020 18:15:48 +0000</pubDate>
				<category><![CDATA[The Beacon]]></category>
		<category><![CDATA[deregulation]]></category>
		<category><![CDATA[Federal Regulations]]></category>
		<category><![CDATA[government and politics]]></category>
		<category><![CDATA[President Trump]]></category>
		<category><![CDATA[Regulation]]></category>
		<category><![CDATA[Trump administration]]></category>
		<guid isPermaLink="false">https://blog.independent.org/?p=46979</guid>

					<description><![CDATA[<p>Writing at the Washington Post, economics columnist Robert J. Samuelson considers the president&#8217;s track record on his deregulatory agenda and sees slower progress ahead. First, though, he notes several successes of deregulation: Some regulatory cutbacks are well-known. The administration decided to pull out of the Paris climate accord; Congress modified the Dodd-Frank financial services...<br /><a href="https://blog.independent.org/2020/01/28/trump-administration-finds-that-deregulation-is-getting-harder-and-harder/">Read More &#187;</a></p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2020/01/28/trump-administration-finds-that-deregulation-is-getting-harder-and-harder/">Trump Administration Finds That Deregulation Is Getting Harder and Harder</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Writing at the <i>Washington Post</i>, economics columnist Robert J. Samuelson <a href="https://www.washingtonpost.com/opinions/theres-a-brawl-coming-over-government-regulation/2020/01/12/5328e798-33e4-11ea-91fd-82d4e04a3fac_story.html">considers the president&#8217;s track record on his deregulatory agenda</a> and sees slower progress ahead. First, though, he notes several successes of deregulation:<span id="more-46979"></span></p>
<blockquote><p>Some regulatory cutbacks are well-known. The administration decided to pull out of the Paris climate accord; Congress modified the Dodd-Frank financial services legislation (one change: The definition of “systemically important” bank, subject to more scrutiny, was <a href="https://books.google.com/books?id=9Q5DVZMm7q8C&amp;pg=PA330&amp;lpg=PA330&amp;dq=dodd-frank,+systemically+important,+250+billion+assets,+32+banks&amp;source=bl&amp;ots=4jrX4uVGEA&amp;sig=ACfU3U2QEoytOR9_UVTo4LAoN9g8Sduktg&amp;hl=en&amp;ppis=_e&amp;sa=X&amp;ved=2ahUKEwj_6ue80fnmAhWJm-AKHbfuDMkQ6AEwB3oECAsQAQ#v=onepage&amp;q=dodd-frank%2C%20systemically%20important%2C%20250%20billion%20assets%2C%2032%20banks&amp;f=false" target="_blank" rel="noopener noreferrer">raised from $50 billion in assets to $250 billion</a>, exempting 32 banks); the Methane and Waste Prevention Rule, which set limits on gas flaring, <a href="https://www.energy.senate.gov/public/index.cfm/2018/9/cantwell-challenges-zinke-s-decision-to-rollback-rule-that-prevents-waste-and-saves-taxpayers-money" target="_blank" rel="noopener noreferrer">was repealed</a>.</p>
<p>It’s also true that the number of new economically significant regulations has slowed appreciably, according to a new study by Andrew Hunter of Capital Economics, a forecasting and consulting firm. In Trump’s first term, 98 have been finalized, well below President Barack Obama’s 175 total for the same period of his administration. (An economically significant change is judged to have an annual effect on the economy of at least $100 million.)</p>
<p>There were some apparent successes. The National Federation of Independent Business (NFIB), a lobbying group for small and medium-size firms, reported that the share of its members “saying red tape is the single biggest problem” dropped from <a href="https://www.nfib.com/assets/SBET-December-2016.pdf" target="_blank" rel="noopener noreferrer">about 20 percent</a>, when Trump was elected, to 12 percent now.</p></blockquote>
<p>That&#8217;s a big change in public perception within a group that pays close attention to the burdens of government regulation, which is perhaps President Trump&#8217;s biggest achievement to date. Samuelson observes, however, that by at least one measure, the federal government&#8217;s regulatory regime hasn&#8217;t diminished all that much:</p>
<blockquote><p>For starters, the size of the regulatory complex stayed roughly the same, Hunter reported. The number of pages in the Code of Federal Regulations&#8212;one standard indicator of the size of the regulatory state&#8212;barely budged. It was <a href="https://www.thepolicycircle.org/brief/government-regulation/" target="_blank" rel="noopener noreferrer">185,434 in 2018</a>, down less than 1 percent from the <a target="_blank" rel="noopener noreferrer">186,374 in 2017</a>.</p></blockquote>
<p>That meager result is a consequence of the administration&#8217;s strategy of focusing first on the regulation tree&#8217;s low-hanging fruit. By focusing on restricting the growth of new regulations, the administration has not been able to dismantle the much larger body of existing regulations. Addressing those regulations will require considerably more effort, as Samuelson notes, which will also require building up public support for the regulatory reforms:</p>
<blockquote><p>Where there does seem to be consensus is the difficulty of abolishing existing regulations. The stability of the regulatory state reflects many factors. One is the law. “The process for repealing or amending federal regulations is lengthy, requiring detailed analysis, reviews and public comment periods,” Hunter noted. Another is popularity. Despite much anti-regulatory rhetoric, there is broad support for agencies overseeing the environment, securities markets, drugs, new vehicles&#8212;and much more. Americans don’t want “free market” forces to settle all controversial questions; but neither do they want the economy to be paralyzed by waves of bureaucratic reports and mandates.</p></blockquote>
<p>Those aren&#8217;t necessarily unreasonable concerns on the part of the public, large portions of which will be happy if President Trump&#8217;s deregulatory efforts going forward strike a balance among all interests, rather than becoming some kind of free-wheeling exercise in deregulation that benefits only a handful of the president&#8217;s political supporters.</p>
<p>The latter path, we must keep in mind, is how we got so many costly and burdensome rules and restrictions on the books in the first place, as previous administrations let the regulatory pendulum swung too far in favor of special interests who benefited from the imposition of restrictions that help them, such as by disproportionately harming their competitive rivals in the marketplace.</p>
<p>If you need an example of a regulation having this type of disproportionate, anti-competitive impact, consider that California&#8217;s <a href="https://www.mediaite.com/opinion/thanks-to-californias-insane-new-ab5-law-you-will-be-reading-me-a-lot-less-on-mediaite-in-2020/" target="_blank" rel="noopener noreferrer">controversial AB5 law</a> was cut from exactly that sort of regulatory heavy cloth.</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2020/01/28/trump-administration-finds-that-deregulation-is-getting-harder-and-harder/">Trump Administration Finds That Deregulation Is Getting Harder and Harder</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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		<title>Is Right-to-Try Legislation a Bust? Time for a Second Opinion.</title>
		<link>https://blog.independent.org/2019/10/17/is-right-to-try-legislation-a-bust-time-for-a-second-opinion/</link>
		
		<dc:creator><![CDATA[Raymond J. March]]></dc:creator>
		<pubDate>Thu, 17 Oct 2019 17:02:57 +0000</pubDate>
				<category><![CDATA[The Beacon]]></category>
		<category><![CDATA[cancer drugs]]></category>
		<category><![CDATA[deregulation]]></category>
		<category><![CDATA[expanded access program]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA and drug regulation]]></category>
		<category><![CDATA[legislation]]></category>
		<category><![CDATA[Regulation]]></category>
		<category><![CDATA[Right to Try]]></category>
		<guid isPermaLink="false">https://blog.independent.org/?p=46013</guid>

					<description><![CDATA[<p>In 2001, twenty-one-year-old Abigail Burroughs was dying of cancer. After all conventional treatment methods failed to improve her condition, Abigail’s oncologist pleaded with the Food and Drug Administration to allow her to try Erbitux. At the time, Erbitux had not fully passed the FDA’s drug approval process. Abigail was denied access and lost her...<br /><a href="https://blog.independent.org/2019/10/17/is-right-to-try-legislation-a-bust-time-for-a-second-opinion/">Read More &#187;</a></p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2019/10/17/is-right-to-try-legislation-a-bust-time-for-a-second-opinion/">Is Right-to-Try Legislation a Bust? Time for a Second Opinion.</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>In 2001, twenty-one-year-old <a href="http://abigail-alliance.org/story.php">Abigail Burroughs</a> was dying of cancer. After all conventional treatment methods failed to improve her condition, Abigail’s oncologist pleaded with the Food and Drug Administration to allow her to try Erbitux. At the time, Erbitux had not fully passed the FDA’s <a href="https://www.fdareview.org/issues/the-drug-development-and-approval-process/">drug approval process</a>. Abigail was <a href="http://abigail-alliance.org/story.php">denied access</a> and lost her battle to cancer shortly after. The FDA eventually approved Erbitux <a href="https://www.drugs.com/history/erbitux.html">in 2004</a> to treat the same cancer which cost Abigail her life.</p>
<p>Heartbreaking stories like Abigail’s (and <a href="https://qz.com/556638/25450-americans-will-die-this-year-waiting-for-cancer-drugs-that-could-treat-them/">thousands of others</a>) provoked a country-wide movement to allow terminally ill patients the right to try experimental treatments to prolong their lives. This movement became the impetus for right-to-try legislation. Right-to-try legislation grants patients with terminal illnesses access to potentially lifesaving drugs before the FDA fully approves them. By side-stepping the FDA’s formal approval process, decisions to try unproven, although potentially beneficial, treatments are left to patients, physicians, and drug producers.<span id="more-46013"></span></p>
<p>The movement spread quickly, becoming “<a href="https://www.statnews.com/2017/03/23/right-to-try/">law of the land</a>” for many states. By 2017, <a href="http://righttotry.org/in-your-state/">forty-one states</a> passed right-to-try laws. Then, in May 2018, President Trump signed right-to-try legislation into <a href="https://www.cbsnews.com/news/right-to-try-bill-trump-signing-will-it-help-terminally-ill-patients-today-2018-05-30/">national law</a>, allowing terminal patients across the country to access experimental medication without requiring permission from the FDA.</p>
<p>But legislation which curbs government power is rarely met without resistance. In route to becoming national law, right-to-try endured considerable criticism. It was called a “<a href="https://www.statnews.com/2018/06/05/right-to-try-compassionate-use-pharma-compliance/">cruel joke</a>,” a “<a href="http://www.latimes.com/business/hiltzik/la-fi-hiltzik-right-to-try-20180604-story.html">sham</a>,” and “<a href="https://news.vice.com/en_us/article/mbk3gp/why-the-right-to-try-bill-trump-just-signed-could-offer-false-hope-to-patients">false hope</a>,” among other defamations. Others claimed the law was “<a href="http://www.latimes.com/business/hiltzik/la-fi-hiltzik-right-to-try-20180604-story.html">tailored to undermine public health</a>” and that it “<a href="https://www.wsj.com/articles/the-right-to-try-bill-wasnt-worth-passing-1528126185">wasn’t worth passing</a>.”</p>
<p>National right-to-try legislation passed nearly a year and a half ago. Have its critics quieted? Hardly. Much of the right-to-try critics’ rhetoric remains the same. Now, however, they have added “<a href="https://sciencebasedmedicine.org/federal-right-to-try-over-a-year-later-still-a-failure-and-still-about-the-money-and-weakening-the-fda/">failure</a>” to their list smears.</p>
<p>A recent <a href="https://www.latimes.com/business/story/2019-09-17/hiltzik-koch-right-to-try-law-bust">piece</a> published in the <em>Los Angeles Times</em> claims the law has been a “bust” and “a cynical ploy aimed at emasculating the Food and Drug Administration in a way that would undermine public health and harm all patients.” <a href="https://www.statnews.com/pharmalot/2019/09/12/right-to-try-fda-reviews/">Others</a> echo similar sentiments.</p>
<p>Why is right-to-try a bust? The column’s author and many other critics hold that, because noticeably few terminally ill patients have used the right-to-try process, it has failed those it intended to help. In his own words:</p>
<blockquote><p>Right-to-try advocates claim that two patients have benefited from federal law thus far. But the claim doesn’t hold water. In one case involving an anonymous patient suffering from glioblastoma... turns out that both the FDA and the institutional review board of UC Irvine [where treatment occurred] were involved in oversight. <a href="https://thehealthcareblog.com/blog/2019/01/18/a-bizarre-claim-of-right-to-try/">According to Caplan and two colleagues</a> who reviewed the case in January, providing the patient with the drug, Gliovec, took longer than it would have under existing FDA procedures.</p></blockquote>
<p>It seems the <em>Los Angeles Times</em> columnist is confused over what right-to-try legislation offers. The law provides terminally ill patients the option to try experimental medication without requiring the FDA’s approval. Drug providers may decide to involve the FDA for <a href="https://www.gao.gov/assets/710/701243.pdf">a variety of reasons</a>. However, this is entirely different from requiring the FDA’s approval to administer treatment. Similarly, UC Irvine is where the patient received treatment. Involving the university’s review board hardly seems to undermine right-to-try legislation.</p>
<p>The column’s author also prematurely concludes that treatment under right-to-try “took longer than it did under existing FDA procedures.” By existing FDA procedures, the author means the FDA’s <a href="https://www.fda.gov/news-events/public-health-focus/expanded-access">Expanded Access Program</a>, which also grants terminally ill patients access to experimental treatments. The author is correct that the FDA often <a href="https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm">quickly approves</a> applications for expanded access. He fails to mention how <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443564/">involved and time-consuming</a> applying for expanded access can be. Right-to-try allows those seeking treatment to avoid this <a href="https://navigator.reaganudall.org/company-guidance">application process</a>, saving them precious time. As the lead medical investigator caring for the patient explained in a statement, “It was believed that (Right to Try) offered a more expedited path to treatment, which UCI began after meeting regulatory and compliance requirements of state and federal Right to Try laws.”</p>
<p>The author continues:</p>
<blockquote><p>A second case involves Matthew Bellina, a victim of amyotrophic lateral sclerosis or Lou Gehrig’s disease, who was treated with a drug called NurOwn by manufacturer Brainstorm under the right-to-try law. But the drug hasn’t been shown to be significantly more effective <a href="https://www.fiercebiotech.com/brainstorm-mulls-making-modest-profits-from-providing-unproven-cell-therapy-a-right-to-try-basis">than a placebo</a>, and Brainstorm says it’s not giving the drug to any more patients under right-to-try but would continue testing the drug via an FDA-approved Phase 3 trial, which it called “the best and most credible pathway” to establishing the safety and efficacy of NurOwn for ALS.</p></blockquote>
<p>The author omits that the reason Brainstorm is no longer offering NurOwn is because of their <a href="https://www.fiercebiotech.com/brainstorm-backs-down-from-providing-als-treatment-under-right-to-try">financial limitations</a>, not because of the right-to-try process. His claim that NurOwn is no more effective than a placebo is <a href="https://www.mmm-online.com/home/channel/roundup/five-things-for-pharma-marketers-to-know-thursday-june-21-2018/">incorrect</a>. Recently, the FDA approved NurOwn for <a href="http://ir.brainstorm-cell.com/news-releases/news-release-details/fda-grants-fast-track-designation-nurowntm-treatment-als">fast-track status</a>, allowing it to advance to full approval more quickly due to demonstrated effectiveness.</p>
<p>We should also recall the inspiring story of <a href="https://catalyst.independent.org/2019/07/02/right-to-try-legislation-helps-patient-battling-bone-cancer/">Natalie Harp</a>, who gained access to experimental treatment under right-to-try laws to treat bone cancer. <a href="https://righttotry.org/right-to-try-is-working/">Several terminally ill patients</a> also benefited from state-level right-to-try legislation before it became national. It is difficult to see how any of these stories constitute a “failure.”</p>
<p>I do agree with the author, however, that right-to-try is <a href="https://blog.independent.org/2018/11/15/to-help-the-terminally-ill-the-fda-must-deregulate/">underused</a>. Fortunately, efforts to expand its role in helping those with terminal illnesses are <a href="https://www.heartland.org/news-opinion/news/lawmakers-call-for-federal-right-to-try-expansion">underway</a>. However, until criticism of right-to-try is addressed, misconceptions and false allegations will continue to undermine efforts to help the terminally ill. It’s a cause worth defending, and I’ll gladly continue to do so.</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2019/10/17/is-right-to-try-legislation-a-bust-time-for-a-second-opinion/">Is Right-to-Try Legislation a Bust? Time for a Second Opinion.</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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		<title>Thoughts on Housing Affordability and Homelessness in California</title>
		<link>https://blog.independent.org/2019/09/18/thoughts-on-housing-affordability-and-homelessness-in-california/</link>
		
		<dc:creator><![CDATA[Adam Summers]]></dc:creator>
		<pubDate>Wed, 18 Sep 2019 17:07:20 +0000</pubDate>
				<category><![CDATA[The Beacon]]></category>
		<category><![CDATA[affordable housing]]></category>
		<category><![CDATA[California]]></category>
		<category><![CDATA[CEQA]]></category>
		<category><![CDATA[deregulation]]></category>
		<category><![CDATA[homeless]]></category>
		<category><![CDATA[homelessness]]></category>
		<category><![CDATA[Housing]]></category>
		<category><![CDATA[housing crisis]]></category>
		<category><![CDATA[mental health]]></category>
		<category><![CDATA[minimum wage]]></category>
		<category><![CDATA[Occupational licensing]]></category>
		<category><![CDATA[payday lending]]></category>
		<category><![CDATA[Regulation]]></category>
		<category><![CDATA[San Francisco]]></category>
		<category><![CDATA[zoning]]></category>
		<guid isPermaLink="false">https://blog.independent.org/?p=45680</guid>

					<description><![CDATA[<p>Improving housing affordability will significantly reduce homelessness, but it will not in itself solve the problem.</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2019/09/18/thoughts-on-housing-affordability-and-homelessness-in-california/">Thoughts on Housing Affordability and Homelessness in California</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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										<content:encoded><![CDATA[<p>I am honored to have been invited to join a group of policy experts in the <a href="http://socalpolicy.org/" target="_blank" rel="noopener noreferrer">SoCal Policy Forum</a>, a project of the Southern California News Group&#8212;which consists of 11 Southern California newspapers, including the <em>Orange County Register</em>, (Riverside) <em>Press-Enterprise</em>, <em>Los Angeles Daily News</em>, (Torrance) <em>Daily</em> Breeze, and <em>Long Beach Press-Telegram</em>&#8212;and the University of California, Riverside. The experts, who have a diverse set of viewpoints and backgrounds, are asked on a quarterly basis to briefly weigh in on issues of the day, and their responses are published on the project&#8217;s <a href="http://socalpolicy.org/" target="_blank" rel="noopener noreferrer">website</a>. Other project contributions include full-length columns in the newspapers and community forums with the experts and state and local stakeholders.</p>
<p>The SoCal Policy Forum recently kicked off with its first set of issues, tackling housing affordability and homelessness. My responses are available at the project&#8217;s <a href="http://socalpolicy.org/housing-homelessness-forum/" target="_blank" rel="noopener noreferrer">site</a>, but I am copying them below since it is easier to see them all in one place, since the site organizes the experts&#8217; responses randomly for each question, rather than by author.</p>
<p><span id="more-45680"></span></p>
<p><strong><u>Question 1:</u> From your perspective, how are the problems of housing affordability and homelessness linked, and how are they different?</strong></p>
<p>There is certainly a good deal of overlap between the housing affordability and homelessness crises, particularly here in California, because financial issues are one of the leading causes of homelessness, and housing is typically one’s greatest expenditure. But there are a number of other reasons people become homeless&#8212;including job loss, substance abuse, mental health issues, physical disabilities and medical emergencies, death of a loved one (particularly a head of household) and other family issues&#8212;so it is far from a perfect correlation.</p>
<p>According to San Francisco’s 2019 <a href="http://hsh.sfgov.org/wp-content/uploads/FINAL-PIT-Report-2019-San-Francisco.pdf" target="_blank" rel="noopener noreferrer">survey</a> of the homeless, for example, the loss of a job was the No. 1 primary reason for homelessness (26 percent), followed by alcohol or drug abuse (18 percent), eviction (13 percent), being kicked out by family or friends (12 percent), and mental health issues (8 percent).</p>
<p>As a result, improving housing affordability (as well as other costs of living and making it easier for people to obtain sound employment) will significantly reduce homelessness, but it will not in itself solve the problem, just as focusing solely on substance abuse and mental health issues will not eliminate it. This is why homelessness, especially, is such a difficult problem, and why steps must be taken in a number of policy areas&#8212;from taxation and regulation to housing to job growth and economic opportunity&#8212;to adequately address these issues.</p>
<p><strong><u>Question 2:</u> From your perspective, what is missing in the HOUSING AFFORDABILITY conversation so far in Southern California? And in looking for solutions, what role should government (federal, state, or local) play? And what roles should the private sector and non-profits sector play?</strong></p>
<p>There is a growing realization that California’s housing crisis is fundamentally a supply problem, but too many of the commonly proposed solutions fail to address the issues that discourage homebuilding in the state&#8212;and many would even make things worse.</p>
<p>Soaking taxpayers with expensive housing bonds will only add to their cost burdens, and making housing less profitable through rent control or affordable housing mandates only inhibits the investment needed for more housing. Even government-funded “affordable housing” developments average about <a href="https://californiaglobe.com/governor/californias-unaffordable-affordable-housing-scandal/" target="_blank" rel="noopener noreferrer">$425,000 per unit</a>, and can reach <a href="https://blogs.wsj.com/economics/2018/09/21/it-can-cost-750000-to-build-an-affordable-housing-unit-in-california-heres-why/" target="_blank" rel="noopener noreferrer">$700,000 or more per unit</a>.</p>
<p>The state and local governments should, instead, simply remove the obstacles they have put in place that have driven up land and construction prices so much. Restrictive zoning limits the amount of land that can be developed, thus driving up prices, and has been used to discourage more affordable options like boarding houses. <a href="https://ternercenter.berkeley.edu/construction-costs-series" target="_blank" rel="noopener noreferrer">Development fees average more than $23,000 per single-family home</a>&#8212;about three times the national average&#8212;and can be much higher in certain areas, <a href="http://ternercenter.berkeley.edu/uploads/Development_Fees_Slide_Deck_Final_1.pdf" target="_blank" rel="noopener noreferrer">topping $60,000 per home in Oakland and totaling roughly $150,000 per home in Irvine and Fremont</a>. Prevailing (union) wage mandates drive up construction labor costs by <a href="https://pdfs.semanticscholar.org/27c6/6044334ed8a110f5c108204ac7b755392fb4.pdf" target="_blank" rel="noopener noreferrer">as much as 30 percent</a>. The California Environmental Quality Act has been used to squash or tie up developments for years and “greenmail” developers into adopting prevailing wage requirements and extract additional amenities and other concessions, further discouraging homebuilding. Excessive building code requirements also add to home prices, and <a href="https://www.forbes.com/sites/michaelshellenberger/2018/05/10/californias-solar-roof-law-will-increase-housing-energy-prices-and-do-little-to-reduce-emissions/#764a2ad93199" target="_blank" rel="noopener noreferrer">the solar roof mandate will likely add another $10,000 to $20,000 to the cost of a home</a>, beginning next year.</p>
<p>Getting rid of so many taxes, fees and regulations&#8212;which easily account for one-quarter or more of the price of a new home (see <a href="http://www.nahbclassic.org/fileUpload_details.aspx?contentTypeID=3&amp;contentID=250611&amp;subContentID=670247&amp;channelID=311" target="_blank" rel="noopener noreferrer">here</a> and <a href="http://www.nahbclassic.org/fileUpload_details.aspx?contentTypeID=3&amp;contentID=262391&amp;subContentID=712894" target="_blank" rel="noopener noreferrer">here</a>)&#8212;would bring down housing costs substantially and spur the development needed to meet demand.</p>
<p><strong><u>Question 3:</u> From your perspective, what is missing in the HOMELESSNESS conversation so far in Southern California? And in looking for solutions, what role should government (federal, state, or local) play? And what roles should the private sector and non-profits sector play?</strong></p>
<p>It strikes me that there are a couple of aspects of the homelessness problem that need more attention, one demographic and one economic.</p>
<p>The demographics of the homeless population are complex, and people become and remain homeless for a variety of reasons, which is why there is no single “silver bullet” to solving the problem. Some see homeless people as primarily those with drug and alcohol addiction problems or mental health issues, while others see people mainly down on their luck due to financial issues, oftentimes beyond their control, who just need a temporary helping hand. There is truth to both views, and both of these issues represent significant pieces to the puzzle, but the reality is more nuanced and varied, as noted in the response to the first question above.</p>
<p>Many acknowledge that securing a decent job is among the best ways for one to get himself or herself out of homelessness, but not enough attention is paid to the impediments that make this so much more difficult. Occupational licensing laws, for example, serve as a barrier to work by imposing government fees and oftentimes unnecessary education and training requirements, like hair braiders forced to attend expensive cosmetology schools to learn skills they will never use.</p>
<p>In addition, a job paying $10 an hour might allow a homeless person to live in a boarding house or stay temporarily in a flophouse until he can work his way up the economic ladder, but minimum wage laws and zoning restrictions prevent such arrangements. Even payday loans, though they may not be cheap and are often demonized, nonetheless help many get through short-term financial emergencies. These may not be ideal arrangements, but they are still much better alternatives than resorting to loan sharks or sleeping in one’s vehicle or on the street.</p>
<p><strong><u>Question 4:</u> Is there anything else you would like to add on the topic of affordable housing or homelessness?</strong></p>
<p>As much as we would all like to eradicate homelessness altogether, we must recognize that some portion of the homeless population will refuse all help, and direct our scarce resources to those who can most likely benefit from them. The hard truth is that we cannot force assistance on those who reject it, and we cannot afford to waste time and money on them when those efforts could be so helpful to others willing to do what it takes to improve their situation.</p>
<p>Finally, precisely because our resources are scarce, it would be more effective for individuals concerned with the homelessness problem to direct their time and money to private charities, rather than large, sweeping government programs (with their large, sweeping government bureaucracies). Private charities generally are more responsive to the needs of their communities because they have greater local knowledge of what must be done, and they have greater incentives to show positive results in order to generate future donations. Heavy-handed government involvement, by contrast, relies on compulsion (i.e., taxation) instead of charity, and need not be effective in order to continue receiving its funding.</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2019/09/18/thoughts-on-housing-affordability-and-homelessness-in-california/">Thoughts on Housing Affordability and Homelessness in California</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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		<title>New Study Finds FDA in Contempt of the U.S. Constitution</title>
		<link>https://blog.independent.org/2019/08/01/new-study-finds-fda-in-contempt-of-the-u-s-constitution/</link>
		
		<dc:creator><![CDATA[Raymond J. March]]></dc:creator>
		<pubDate>Thu, 01 Aug 2019 22:39:43 +0000</pubDate>
				<category><![CDATA[The Beacon]]></category>
		<category><![CDATA[Bureaucracy and Government]]></category>
		<category><![CDATA[Department of Health and Human Services]]></category>
		<category><![CDATA[deregulation]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA and drug regulation]]></category>
		<category><![CDATA[Right to Try]]></category>
		<category><![CDATA[U.S. Constitution]]></category>
		<guid isPermaLink="false">https://blog.independent.org/?p=45253</guid>

					<description><![CDATA[<p>According to a recent study by the Pacific Legal Foundation, 2,094 out of the 2,952 regulations issued from 2001 until 2017 by the Department of Health and Human Services were unconstitutional.</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2019/08/01/new-study-finds-fda-in-contempt-of-the-u-s-constitution/">New Study Finds FDA in Contempt of the U.S. Constitution</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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										<content:encoded><![CDATA[<p>A recent <a href="https://pd.pacificlegal.org/HHSReport" target="_blank" rel="noopener noreferrer">study</a> conducted by the Pacific Legal Foundation examined 2,952 regulations issued from 2001 until 2017 by the Department of Health and Human Services. The study found that 2,094 of these regulations (about 75 percent) were <a href="https://pd.pacificlegal.org/HHSReport" target="_blank" rel="noopener noreferrer">unconstitutional</a>. Many of these rules negatively impacted small businesses and individuals’ well-being.</p>
<p>The HHS’s unconstitutional, excessive, and harmful rulemaking were <a href="https://thehill.com/opinion/judiciary/440710-1860-unconstitutional-fda-rules" target="_blank" rel="noopener noreferrer">nearly entirely driven</a> by its largest agency, the Food and Drug Administration. Over the same period, <a href="https://pd.pacificlegal.org/HHSReport" target="_blank" rel="noopener noreferrer">98 percent</a> of the regulations enacted by the FDA (totaling 1,860) were found unconditional. Twenty-five of these rules had an economic impact of at least <a href="https://pd.pacificlegal.org/HHSReport" target="_blank" rel="noopener noreferrer">$100 million</a>.</p>
<p><span id="more-45253"></span></p>
<p>Perhaps even more worrisome is what makes these regulations unconstitutional (and illegal). The Constitution requires that regulations enacted by federal agencies such as the FDA or their umbrella departments such as the HHS come from <a href="https://www.fda.gov/about-fda/fda-organization/fda-leadership-profiles" target="_blank" rel="noopener noreferrer">principal officers</a>. Typically, these officers are appointed by the President after Senate confirmation.</p>
<p>However, the vast majority of these regulations <a href="https://pd.pacificlegal.org/HHSReport" target="_blank" rel="noopener noreferrer">were passed by</a> “low-level officials and employees with no authority to issue rules.” Legally, these regulations cannot be backed by the rule of law. As Thomas Berry, one of the study’s co-authors, <a href="https://pacificlegal.org/press-release/new-study-finds-98-of-fda-rules-over-17-years-are-unconstitutional/" target="_blank" rel="noopener noreferrer">notes</a>, “Only properly appointed officers in the executive branch may issue regulations that are binding on the public. This preserves democratic accountability for significant executive branch actions.”</p>
<p>But the <a href="https://www.sciencemag.org/news/2019/07/exclusive-fda-enforcement-actions-plummet-under-trump" target="_blank" rel="noopener noreferrer">frequency</a> of FDA’s issuance of fines and product-recall mandates strongly suggests the Constitution has little authority to restrict the agency’s “<a href="https://www.fda.gov/about-fda/history-fdas-internal-organization/fdas-evolving-regulatory-powers" target="_blank" rel="noopener noreferrer">evolving regulatory powers</a>.” Unfortunately, these powers have been evolving since at <a href="https://www.fdareview.org/issues/history-of-federal-regulation-1902-present/" target="_blank" rel="noopener noreferrer">least the 1930s</a>. Regularly allowing those with no legal authority to issue regulations is one of many examples.</p>
<p>So what can be done to hold these regulators accountable? Although difficult, the answer is to reduce their power. Luckily, pressure from the Trump administration <a href="https://www.sciencemag.org/news/2019/07/exclusive-fda-enforcement-actions-plummet-under-trump" target="_blank" rel="noopener noreferrer">to deregulate</a> has shown some success in reducing the FDA’s enforcement actions. <a href="https://thehill.com/opinion/healthcare/396916-right-to-try-is-just-what-the-doctor-ordered" target="_blank" rel="noopener noreferrer">Right-to-try legislation</a> reduces the agency’s authority to restrict access to potentially life-saving but unapproved treatments for patients with terminal illnesses. <a href="https://thehill.com/policy/healthcare/454631-trump-gives-boost-to-state-drug-import-plans" target="_blank" rel="noopener noreferrer">Other efforts</a> to deregulate are also underway.</p>
<p>The findings in the Pacific Legal Foundation’s study are alarming but predictable. Government power, including its influence over the healthcare field, increases rapidly when it is left unchecked. The FDA’s rapid and illegal regulatory expansion is just one example. Let’s hope studies like these <a href="https://www.mercatus.org/publications/need-fda-reform-four-models" target="_blank" rel="noopener noreferrer">and others</a> motivate the public to push back and discipline the FDA. It’s certainly overdue.</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2019/08/01/new-study-finds-fda-in-contempt-of-the-u-s-constitution/">New Study Finds FDA in Contempt of the U.S. Constitution</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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		<title>Sacramento Slashes Fees on Housing Development</title>
		<link>https://blog.independent.org/2018/11/16/sacramento-slashes-fees-on-housing-development/</link>
		
		<dc:creator><![CDATA[K. Lloyd Billingsley]]></dc:creator>
		<pubDate>Fri, 16 Nov 2018 17:00:54 +0000</pubDate>
				<category><![CDATA[The Beacon]]></category>
		<category><![CDATA[CA Prop 10]]></category>
		<category><![CDATA[deregulation]]></category>
		<category><![CDATA[housing crisis]]></category>
		<category><![CDATA[housing shortage]]></category>
		<category><![CDATA[Rent control]]></category>
		<category><![CDATA[sacramento city council]]></category>
		<guid isPermaLink="false">http://blog.independent.org/?p=42404</guid>

					<description><![CDATA[<p>Deregulation to answer housing shortage. </p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2018/11/16/sacramento-slashes-fees-on-housing-development/">Sacramento Slashes Fees on Housing Development</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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										<content:encoded><![CDATA[<p>Last month, before the misguided Proposition 10 rent control measure failed, the Sacramento City Council voted unanimously to <a href="https://sacramentocityexpress.com/2018/10/31/city-council-votes-to-slash-fees-to-spur-more-affordable-housing-construction-in-sacramento/">cut many city development fees</a> for qualified affordable housing units. The sewer development fee, the water system development fee and the park development impact fee will all be reduced to zero dollars and this will trim costs from $10,000 to $13,000 per housing unit. The fee reductions are part of a quest to spur more development of affordable units at a faster pace. On that theme, a local example may prove instructive.</p>
<p>Back in 2007, a <a href="https://www.reuters.com/article/unionpacific-fire/fire-destroys-union-pacific-bridge-in-sacramento-idUSN1646582720070316">fire consumed 1,400 feet</a> of a 2,200-foot wooden Union Pacific trestle bridge on a heavily used rail line for consumer goods and passengers alike. The city of Sacramento promptly waved regulations for reconstruction of the trestle in steel and concrete. The fire started on March 15 and Union Pacific crews had the <a href="https://www.ocregister.com/2007/03/28/sacramento-train-trestle-span-reopens-after-massive-fire/">new trestle in place by March 28</a>, so within two weeks people and goods were rolling again. Similarly, if officials want more affordable housing at a faster rate, they must start slashing or eliminating the fees and regulations that bulk up costs, with zoning restrictions as a priority. As <a href="https://www.mercatus.org/publications/zoning-and-land-use-regulations-make-housing-less-affordable">Emily Hamilton of the Mercatus Center</a> notes, “when supply constraints prevent new construction in the places where people want to live, only zoning reform can increase access to housing.”</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2018/11/16/sacramento-slashes-fees-on-housing-development/">Sacramento Slashes Fees on Housing Development</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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		<title>To Help the Terminally Ill, the FDA Must Deregulate</title>
		<link>https://blog.independent.org/2018/11/15/to-help-the-terminally-ill-the-fda-must-deregulate/</link>
		
		<dc:creator><![CDATA[Raymond J. March]]></dc:creator>
		<pubDate>Thu, 15 Nov 2018 18:00:36 +0000</pubDate>
				<category><![CDATA[The Beacon]]></category>
		<category><![CDATA[ALS]]></category>
		<category><![CDATA[Brainstorm Cell Therapeutics]]></category>
		<category><![CDATA[compassionate use]]></category>
		<category><![CDATA[deregulation]]></category>
		<category><![CDATA[expanded access program]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[pharamaceutical industry]]></category>
		<category><![CDATA[Regulation]]></category>
		<category><![CDATA[Right to Try]]></category>
		<guid isPermaLink="false">http://blog.independent.org/?p=42388</guid>

					<description><![CDATA[<p>Right-to-try will never reach its potential without deregulation. </p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2018/11/15/to-help-the-terminally-ill-the-fda-must-deregulate/">To Help the Terminally Ill, the FDA Must Deregulate</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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										<content:encoded><![CDATA[<p>In a recent <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625397.htm">press statement</a>, Food and Drug Administration Commissioner Scott Gottlieb announced plans to improve and broaden FDA’s <a href="https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm20041768.htm">Expanded Access Program</a>. Sometimes called the Compassionate Use Program, the Expanded Access Program provides terminally ill patients with access to experimental medications before they are fully approved.</p>
<p>Current <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625397.htm">proposed changes</a> to the program include streamlining the submission process that physicians undergo to provide required documentation and allowing individuals (instead of the entire board) to approve treatment requests. The agency also previously commissioned an independent review board to assess aspects of the program needing improvement.</p>
<p>The program has had recent success in expanding access. From 2005 to 2014, the FDA provided<a href="https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm"> approximately 9,000 patients</a> with access to experimental drugs. It has granted access to an equal number of patients in the <a href="https://www.healthexec.com/topics/policy/fda-strengthens-expanded-access-program">last five years</a>.</p>
<p>Although expansion has improved and the FDA’s commitment to helping the terminally ill is praiseworthy, current access levels are a far cry from what is needed.<span id="more-42388"></span></p>
<p>According to the <a href="https://www.nhdd.org/facts/">Pew Research Center</a>, nearly 42 percent of Americans have a friend or relative with a terminal illness or who is in a coma as of 2006. In her book The <em>Right To Try</em>, Darcy Olson notes over <a href="https://qz.com/556638/25450-americans-will-die-this-year-waiting-for-cancer-drugs-that-could-treat-them/">25,000 patients</a> with terminal cancer die each year while waiting for the FDA to approve potentially life-saving medication.</p>
<p>When we consider that the FDA has offered similar programs <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625397.htm">since the 1970s</a>, and the shortcomings of its current program, it’s clear another way to access experimental medication is needed. Fortunately, there is one.</p>
<p>Last May, President Trump signed <a href="https://thehill.com/policy/healthcare/389908-trump-signs-right-to-try-bill-for-terminally-ill-patients">right-to-try legislation</a> into law. Right-to-try laws allow patients with terminal illnesses to access experimental medication with only the approval of their physician and the drug provider. With limited treatments and time, cutting additional barriers to access (even streamlined ones) is critical.</p>
<p>Shockingly, no one has used the right-to-try process. Why? The most likely reason is the high cost of administering treatment caused by excessive regulation.</p>
<p>Even though drugs accessed through right-to-try are only required to pass the first phase of the FDA’s approval process, regulations dictating research, development, and clinical-trial standards can cost drug companies between <a href="https://www.brightfocus.org/clinical-trials/how-clinical-trials-work/fda-approval-process">$50 million and $840 million</a>. Further, many insurance companies are unable or unwilling to cover unapproved drugs, making potentially life-saving drugs unaffordable for most patients.</p>
<p>In June, Brainstorm Cell Therapeutics Inc. attempted to become <a href="http://www.theedgemarkets.com/article/price-try-drug-could-be-300000-dying-patients">the first</a> drug provider to offer terminally ill patients access to experimental treatment for amyotrophic lateral sclerosis (commonly shortened to ALS) through right-to-try legislation. However, even by charging <a href="http://www.theedgemarkets.com/article/price-try-drug-could-be-300000-dying-patients">$300,000</a> per treatment, the company was unable to <a href="https://www.fiercebiotech.com/brainstorm-backs-down-from-providing-als-treatment-under-right-to-try">cover the costs of offering treatment</a>. Its treatment, name <a href="https://alsnewstoday.com/2017/12/12/brainstorm-cmo-talks-in-interview-about-nurown-and-potential-as-therapy-for-als-with-rapid-progression/">NurOwn</a>, will likely be FDA approved in <a href="https://www.fiercebiotech.com/brainstorm-backs-down-from-providing-als-treatment-under-right-to-try">2019 or 2020</a>. This will be too late for many patients currently suffering from ALS.</p>
<p>To give the terminally ill the best chance to prolong their life, greater access to experimental medication is desperately needed. The Expanded Access Program, although helpful, falls short. Right-to-try can provide a much-needed alternative, and less bureaucratic, method. However, it will never reach its potential without deregulation.</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2018/11/15/to-help-the-terminally-ill-the-fda-must-deregulate/">To Help the Terminally Ill, the FDA Must Deregulate</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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		<title>A Boom in Small Business Optimism</title>
		<link>https://blog.independent.org/2018/09/13/a-boom-in-small-business-optimism/</link>
		
		<dc:creator><![CDATA[Craig Eyermann]]></dc:creator>
		<pubDate>Thu, 13 Sep 2018 21:30:35 +0000</pubDate>
				<category><![CDATA[The Beacon]]></category>
		<category><![CDATA[deregulation]]></category>
		<category><![CDATA[President Obama]]></category>
		<category><![CDATA[President Trump]]></category>
		<category><![CDATA[small business]]></category>
		<category><![CDATA[Tax Cuts and Jobs Act]]></category>
		<category><![CDATA[Trump tax cuts]]></category>
		<guid isPermaLink="false">http://blog.independent.org/?p=41690</guid>

					<description><![CDATA[<p>It's amazing what good things can happen when the power and greed of bureaucrats and politicians over regular Americans is diminished!</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2018/09/13/a-boom-in-small-business-optimism/">A Boom in Small Business Optimism</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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										<content:encoded><![CDATA[<p>When President Trump came into office, many small businesses in the United States had been laboring under burdensome conditions for a very long time. Writing at <i>Entrepreneur</i> magazine in 2014, Scott Shane <a href="https://www.entrepreneur.com/article/230727" target="_blank" rel="noopener">identified</a> the regulatory burden imposed by the U.S. government as one of the main contributors to the ongoing malaise of small business owners.</p>
<blockquote><p>One of the best ways for Congress to help small businesses would be to reduce their regulatory burden, which is heavier now than when President Obama took office in January 2009.</p>
<p>This increase in <a href="https://www.entrepreneur.com/topic/regulations">regulation</a> is both unfair and inefficient: Compliance with governmental rules and laws is a greater encumbrance on small companies than large ones, and regulation hinders small business formation, growth, and job creation.</p>
<p>The cost of federal regulations <a href="http://www.heritage.org/research/reports/2013/05/red-tape-rising-regulation-in-obamas-first-term" target="_blank" rel="noopener">rose by $70 billion during the President&#8217;s first term in office</a>, the Heritage Foundation reports. And small business has not been exempted from the rising tide. At the end of 2012, the number of federal regulations affecting small companies <a href="http://www.forbes.com/sites/waynecrews/2013/02/06/small-business-regulations-surge-under-obama/" target="_blank" rel="noopener">was 13 percent higher than at the end of 2008</a>, <i>Forbes</i> reports.</p></blockquote>
<p><span id="more-41690"></span></p>
<p>That burden only <a href="https://cei.org/sites/default/files/Ten%20Thousand%20Commandments%202017.pdf" target="_blank" rel="noopener">continued to grow</a> through President Obama&#8217;s second term in office. So when one of President Trump&#8217;s first acts in office was to order a cut in federal regulations, the small businesses that were disproportionately and negatively impacted by the heavy hand of the regulatory state had reason to begin becoming optimistic. <i>Inc.</i> magazine <a href="https://www.inc.com/associated-press/trump-order-cuts-small-business-regulations.html" target="_blank" rel="noopener">carried a story</a> by the Associated Press at the time.</p>
<blockquote><p><a href="https://www.inc.com/jeff-bercovici/trump-friendship-fiduciary-duty.html?cid=search">President Donald Trump</a> has signed an executive action aimed at <a href="https://www.inc.com/wanda-thibodeaux/trumps-promise-to-reduce-regulation-might-not-have-the-effect-on-innovation-you-.html?cid=search">cutting regulations,</a> and said at a White House breakfast he wanted to &#8220;create an environment for small business.&#8221;</p>
<p>The executive action requires government agencies requesting a new regulation to identify two that they will cut. Trump had pledged during the election campaign to reduce the regulatory burden on small companies.</p></blockquote>
<p>Later in his first year, the President delivered on another campaign promise by signing the Tax Cuts and Jobs Act of 2017 into law, where the two economic measures together promised the potential for a better future to American small businesses operators, as <a href="https://smallbiztrends.com/2018/01/2018-franchise-business-economic-outlook.html" target="_blank" rel="noopener">described</a> by Gabrielle Pickard-Whitehead of <i>Small Business Trends</i>, who focused on what that offered to the owners of franchise businesses in the U.S.</p>
<blockquote><p><a href="https://smallbiztrends.com/category/franchise-trends" target="_blank" rel="noopener">Franchise businesses</a> can look to 2018 with confidence and optimism, benefiting from a climate of tax relief and regulatory reform. This was the finding of the new <a href="https://www.franchise.org/sites/default/files/Franchise_Business_Outlook_Jan_2018.pdf" target="_blank" rel="noopener">Franchise Business Economic Outlook for 2018</a>, which forecasts the franchise sector is strong and expected to grow at a faster pace than the rest of the U.S. economy....</p>
<p>The <a href="https://smallbiztrends.com/2018/01/small-businesses-are-optimistic-over-tax-cuts.html" target="_blank" rel="noopener">Tax Cuts and Jobs Act</a> (TCJA) cuts the corporate tax rate from 35 percent to 21 percent, thereby benefiting franchises and other businesses by giving them a lower tax rate. As the rate cut is permanent, the TCJA provides franchises and other businesses with a predictable tax environment for the foreseeable future.</p></blockquote>
<p>Flash forward nine months later, with the business tax cuts now in effect and a <a href="https://www.investors.com/politics/commentary/deregulation-nation-president-trump-cuts-regulations-at-record-rate/" target="_blank" rel="noopener">confirmed achievement</a> in restraining the growth of the U.S. government&#8217;s regulatory rulebooks, the outlook for American small businesses have improved to where the National Federation of Independent Business&#8217; Small Business Optimism Index is <a href="http://mam.econoday.com/byshoweventfull.asp?fid=486094&amp;cust=mam&amp;year=2018" target="_blank" rel="noopener">now recording its highest levels ever</a> in its 45 year history.</p>
<blockquote><p>The Small Business Optimism Index rose 0.9 points in August to 108.8, a new record in the survey&#8217;s 45-year history. Leading the index higher beyond not only consensus forecasts but also the range of analysts&#8217; expectations was a 6-point gain to a net 10 percent in plans to increase inventories, a 3-point increase to a net 33 percent in plans to make capital outlays, and once again, plans to increase employment, which also rose 3 points to a net 26 percent, a record high....</p>
<p>Featuring the highest reading in inventory investment plans since 2005 and the highest reading for capital spending plans since 2007, as well as historical records in job creation and job openings, the August survey shows small business owners shifting into high gear to realize their earlier less concrete optimistic expectations of better business conditions and the view that now is a good time to expand.</p></blockquote>
<p>Those benefits are also being shared by their employees, where 2018 has seen the number of job openings <a href="https://www.wsj.com/articles/american-jobs-outnumber-the-jobless-1528212776" target="_blank" rel="noopener">exceed</a> the number of jobless Americans for the first time in years, with regular American households benefiting from <a href="https://www.washingtonpost.com/business/2018/09/07/wages-are-finally-rising-more-recovery-might-be-entering-new-phase/" target="_blank" rel="noopener">rising wages</a> and also from <a href="https://www.wsj.com/articles/median-household-income-rose-1-8-in-2017-census-bureau-figures-show-1536762535?mod=hp_lead_pos3" target="_blank" rel="noopener">rising incomes</a>.</p>
<p>It&#8217;s amazing what good things can happen when the power and greed of bureaucrats and politicians over regular Americans is diminished!</p>
<p>The post <a rel="nofollow" href="https://blog.independent.org/2018/09/13/a-boom-in-small-business-optimism/">A Boom in Small Business Optimism</a> appeared first on <a rel="nofollow" href="https://blog.independent.org">The Beacon</a>.</p>
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