{"id":13597,"date":"2019-11-18T16:48:42","date_gmt":"2019-11-18T16:48:42","guid":{"rendered":"http:\/\/freetochoosemedicine.com\/?page_id=13597"},"modified":"2019-11-18T17:08:34","modified_gmt":"2019-11-18T17:08:34","slug":"faq","status":"publish","type":"page","link":"https:\/\/freetochoosemedicine.com\/?page_id=13597","title":{"rendered":"FAQ"},"content":{"rendered":"<p>[vc_row css=&#8221;.vc_custom_1574096909788{padding-bottom: 10px !important;}&#8221;][vc_column][section_header use_decoration=&#8221;1&#8243; layout_type=&#8221;section-heading-underlined&#8221; main_heading=&#8221;Frequently Asked Questions&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]The Heartland Institute\u2019s Free to Choose Medicine (FTCM) project is devoted to offering patients with terminal illnesses the opportunity to safely access treatments that have already passed Phase I safety testing by the U.S. Food and Drug Administration (FDA) and at least one Phase II efficacy test. In the 1990s, FDA successfully implemented a similar exception for HIV\/AIDS patients during the height of the AIDS epidemic. Fortunately, this resulted in the approval of several drugs that improved the quality and length of life for millions of HIV\/AIDS patients across the globe.<\/p>\n<p>Heartland\u2019s FTCM proposal would simply apply the same proven reform for millions of Americans now struggling with debilitating diseases. FDA\u2019s current approval process is far too lengthy (10\u201312 years) and expensive ($2.9 billion). Patients with life-threatening conditions deserve the opportunity to access safe, promising treatments. FTCM would accomplish this urgent and pressing objective.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_accordion active_section=&#8221;125&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;Why Does FDA Need to be Reformed?&#8221; tab_id=&#8221;1574093848182-36222129-5210&#8243;][vc_column_text]<\/p>\n<ul>\n<li>On average, it takes 10\u201312 years at a cost of $2.9 billion for a new drug to go from the research lab to the market, with much of that time and cost devoted to satisfying U.S. Food and Drug Administration regulatory requirements.<\/li>\n<li>The excessive time required for new drug approval unnecessarily delays access to promising new drugs and, in some cases, prolongs illnesses and results in patient deaths.<\/li>\n<li>The costs and time required to win approval for a new drug eliminate many new drug candidates from further development, which results in less competition, less innovation, and higher prices.<\/li>\n<li>FDA\u2019s regulatory monopoly mandates hugely expensive, often unnecessary clinical testing and data analysis that stifles competition and inflates drug costs.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Why Does FDA\u2019s Certification Process Take so Long?&#8221; tab_id=&#8221;1574093848197-c05d5b1c-9d8a&#8221;][vc_column_text]<\/p>\n<ul>\n<li>After several years of product development in private research labs, FDA requires a drug to enter Phase I testing for basic safety.<\/li>\n<li>Safe products then must pass multiple Phase II tests to determine general efficacy and Phase III tests to refine that information.<\/li>\n<li>These latter phases can stretch out for up to a decade. Upon completing all phases, a producer may file a \u201cNew Drug Application,\u201d which can take as many as two years to approve. This all adds up to 10\u201315 years.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Does FDA Have an \u2018Institutional Culture\u2019 That Delays the Approval Process?&#8221; tab_id=&#8221;1574094422929-8ab2fbaa-fb16&#8243;][vc_column_text]<\/p>\n<ul>\n<li>Yes! FDA is overly cautious, but this caution does not make us safer. We all want safe medications, but we also want them in a timely manner. FDA has little incentive to approve drugs quickly.<\/li>\n<li>If FDA approves a treatment that does not perform as effectively as promised, it could suffer poor public relations coverage and possible congressional inquiries.<\/li>\n<li>However, FDA receives little criticism or penalties for requiring years of dubious tests that results in years of patient suffering and unnecessary deaths.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Aren\u2019t These Concerns About FDA Fairly New and Easily Resolved by Internal Reforms?&#8221; tab_id=&#8221;1574094506006-37657db7-50a6&#8243;][vc_column_text]<\/p>\n<ul>\n<li>No! FDA\u2019s failings were made clear during the AIDS epidemic of the 1980s. Individuals suffering from that ailment rightly argued that with only a few years or even months to live, they could not wait for very promising drugs to pass seemingly endless rounds of efficacy tests. They were facing death.<\/li>\n<li>Although some FDA reforms were made to allow expedited and compassionate use, FDA\u2019s problems have continued and arguably worsened.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;How Does the Current FDA Process Hinder Smaller, Innovative Companies?&#8221; tab_id=&#8221;1574094578733-04990564-5203&#8243;][vc_column_text]<\/p>\n<ul>\n<li>Smaller companies cannot afford a decade or more of costs before their products finally reach the market, allowing them to recover their investments. FDA\u2019s draconian system prices them out of the market.<\/li>\n<li>Often, pharmaceutical giants gobble up smaller companies. While this might save some promising research from being shelved, a large, bureaucratic company often can dampen the efforts of visionary, innovative researchers.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;What Is Free to Choose Medicine?&#8221; tab_id=&#8221;1574094626330-85bacd72-79bf&#8221;][vc_column_text]<\/p>\n<ul>\n<li>Free to Choose Medicine is an innovative plan to reform FDA\u2019s current drug approval process. FTCM\u2019s goal is to create a system that provides better drugs, sooner, at lower cost.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;How Does FTCM Work?&#8221; tab_id=&#8221;1574094867840-b601188b-e186&#8243;][vc_column_text]<\/p>\n<ul>\n<li>FTCM creates a parallel and more dynamic track for testing and approval of new drugs. After a new drug passes FDA Phase I safety tests and at least one round of Phase II efficacy testing, a drug manufacturer can choose to proceed on the FTCM parallel track.<\/li>\n<li>On the FTCM track, manufacturers make their drugs available to physicians and their patients. While using the drug, the physician enters patient treatment information, anonymously, into a newly created Tradeoff Evaluation Drug Database (TEDD).<\/li>\n<li>The information and data in TEDD would be accessible online to other physicians so that they can determine whether to advise the drug for their patients.<\/li>\n<li>The information and data in TEDD would also be available to other researchers and pharmaceutical companies to better inform their work and allow them to bring additional new drugs to market faster.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Why Use FTCM\u2019s Tradeoff Evaluation Drug Database?&#8221; tab_id=&#8221;1574095082752-73ccf9bf-d45d&#8221;][vc_column_text]<\/p>\n<ul>\n<li>Under FTCM, patients, advised by their doctors, can make an informed decision as to the use of a not-yet-approved drug that has been allowed on the FTCM track. The characteristics and medical history of the patients as well as the results of the medication are entered into TEDD, with patient privacy protected.<\/li>\n<li>Researchers would also have access to this data, which would spur more drug innovation<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Can You Make the Case for Free to Choose Medicine Less Abstract?&#8221; tab_id=&#8221;1574095151070-6e5665d0-3c27&#8243;][vc_column_text]<\/p>\n<ul>\n<li>Sure. In late 2000, 21-year-old Abigail Burroughs was diagnosed with neck cancer. By March 2001, traditional treatments had failed her. Her physicians then recommended a safe drug stuck in FDA-mandated efficacy tests. Abigail and her family did everything they could to access the promising drug, even making appeals on local TV shows and pulling political strings. Sadly, nothing worked. Abigail died in June 2001. The drug was later approved. The tragic case of Abigail Burroughs inspired the development of FTCM by Bartley Madden.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;How Is FTCM Different from Right to Try Laws?&#8221; tab_id=&#8221;1574095185611-55bdbd8d-04c1&#8243;][vc_column_text]<\/p>\n<ul>\n<li>Right to Try (RTT) laws allow terminally ill patients to access new drugs that have passed Phase I FDA safety testing but about which no determination of efficacy or effectiveness in treating an illness has been made.<\/li>\n<li>FTCM allows early access to a new drug only after it has completed one or more Phase II round of FDA efficacy testing.<\/li>\n<li>RTT laws do not require physicians to report patient treatment data while on the new drug. On the other hand, FTCM requires physicians to report treatment data for their patients on a new drug, thereby offering physicians and patients the data needed to make an informed choice on whether to use a new drug.<\/li>\n<li>FTCM allows market pricing of not-yet-approved drugs. If a new drug generates compelling treatment results, it could receive a new FDA Observational Approval, which would expedite insurance reimbursement.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Would FTCM Eliminate FDA?&#8221; tab_id=&#8221;1574095220310-2c6c792b-101a&#8221;][vc_column_text]<\/p>\n<ul>\n<li>No, Free to Choose Medicine offers a second track for drug development, testing, and approval.<\/li>\n<li>Drug companies can choose to develop, test, and have new drugs approved on FDA\u2019s standard drug approval track or the FTCM track.<\/li>\n<\/ul>\n<p><strong>\u00a0<\/strong>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Would FTCM be Dangerous for Patients?&#8221; tab_id=&#8221;1574095501874-4318351c-a9b9&#8243;][vc_column_text]<\/p>\n<ul>\n<li>No! To get on the FTCM track, a product must pass Phase I safety tests and at least one initial efficacy test to show the product\u2019s promise for safely treating patients.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;How Would FTCM Work for Bio-Hacked or Biologic Treatments?&#8221; tab_id=&#8221;1574095605407-cba553b2-ac74&#8243;][vc_column_text]<\/p>\n<ul>\n<li>The new frontier of medicine includes bio-hacking and engineering cells, blood, or other so-called \u201cbiologics\u201d to treat human ailments.<\/li>\n<li>The best ways to test the efficacy of these cutting-edge treatments might not be the same process FDA uses for testing traditional chemical-based medications.<\/li>\n<li>New ways of testing might be necessary, and FTCM could offer viable alternatives.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Isn\u2019t Free to Choose Medicine a Fringe Idea?&#8221; tab_id=&#8221;1574095628198-d40450a1-e738&#8243;][vc_column_text]<\/p>\n<ul>\n<li>No! Japan recently adopted this approach for regenerative treatments.<\/li>\n<li>About 26.5 percent of Japan\u2019s population is older than 65, the largest proportion of elderly people in any country\u2019s population. Life expectancy in Japan is 83.7, one of the world\u2019s highest.<\/li>\n<li>Japan implemented FTCM to protect its most vulnerable citizens by allowing them to access drugs that could possibly save and prolong their lives.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]<strong>Conclusion<\/strong><\/p>\n<p>Like all industries, when the U.S. health care system has improved, it\u2019s been because of competition and innovations that flow from a free market, not because of government regulation. Free to Choose Medicine offers choice and competition in the marketplace and moves the dial in favor of patient freedom.<\/p>\n<p>The antiquated FDA drug approval process is holding back innovation the private sector is demanding. The government ought to act like a bridge to innovation, not a barrier. FTCM would be an important and lifesaving move in that direction.[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[vc_row css=&#8221;.vc_custom_1574096909788{padding-bottom: 10px !important;}&#8221;][vc_column][section_header use_decoration=&#8221;1&#8243; layout_type=&#8221;section-heading-underlined&#8221; main_heading=&#8221;Frequently Asked Questions&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]The Heartland Institute\u2019s Free to Choose Medicine (FTCM) project is devoted to offering patients with terminal illnesses the opportunity to safely access treatments that have already passed Phase I safety testing by the U.S. Food and Drug Administration (FDA) and at least one Phase II efficacy test.&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v14.6.1 - 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