{"id":1801922,"date":"2023-01-11T08:05:33","date_gmt":"2023-01-11T13:05:33","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1801922"},"modified":"2023-01-11T08:06:42","modified_gmt":"2023-01-11T13:06:42","slug":"is-the-fda-working-for-drug-makers-or-drug-users","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/is-the-fda-working-for-drug-makers-or-drug-users\/","title":{"rendered":"Is the FDA Working for Drug Makers or Drug Users?"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"float:left\"><div class=\"counts mashsbcount\">20<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Fis-the-fda-working-for-drug-makers-or-drug-users%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1801922&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47-->\n<p><span>The U.S. Federal Food and Drug Administration\u2019s (<a href=\"https:\/\/www.theepochtimes.com\/t-fda\">FDA<\/a>)\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/about-fda\/fda-basics\/when-and-why-was-fda-formed\"><span>Origins<\/span><\/a><span> The 1906 Pure Food and Drugs Act was the first act that established the federal consumer protection agency. However, its foundation was not enough to stop low-quality food and drugs from flooding the market. In 1938, Congress passed the Food, Drug, and Cosmetic Act, in response to public outrage. This gave the FDA greater authority to protect U.S. citizens.<\/span><\/p>\n<h2>Early Success<\/h2>\n<p><span>Despite its weaknesses, the FDA, which was completely funded by taxpayers, did at least once protect consumers.\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/about-fda\/fda-history-exhibits\/frances-oldham-kelsey-medical-reviewer-famous-averting-public-health-tragedy\"><span>Rejecting the drug Thalidomide<\/span><\/a><span> This protection is probably one of the most impressive examples. Many countries have approved Thalidomide, which was used in the 1950s to treat morning sickness in women who were pregnant.<\/span><\/p>\n<p><span>Dr. Frances Oldham Kelsey (one of a handful of FDA medical officers at that time) was assigned the task of reviewing the thalidomide request. Despite constant pressure from the drug company, Dr. Kelsey refused to approve the application because she felt it lacked scientifically reliable evidence of the drug\u2019s safety.<\/span><\/p>\n<figure id=\"attachment_4966345\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/Frances-Oldham-Kelsey-300px.jpeg\"><img loading=\"lazy\" decoding=\"async\" class=\"lazy size-full wp-image-4966345\" src=\"https:\/\/www.theepochtimes.com\/assets\/themes\/eet\/images\/white.png\" data-src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/Frances-Oldham-Kelsey-300px.jpeg\" alt=\"Epoch Times Photo\" width=\"300\" height=\"240\"   style=\"display:none\"><figcaption class=\"wp-caption-text\"><noscript><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-4966345\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/Frances-Oldham-Kelsey-300px.jpeg\" alt=\"Epoch Times Photo\" width=\"300\" height=\"240\" \/><\/noscript><\/figcaption><\/a> President Kennedy confers on Dr. Kelsey the President\u2019s Award for Distinguished Federal Civilian Service in 1962. (FDA)<\/figure>\n<p>A year after thalidomide had been introduced to other countries, researchers found a link between it and a serious birth defect that affected thousands of babies. Dr. Kelsey was right to stand by her assertion. In 1962, President Kennedy conferred on Dr. Kelsey the President\u2019s Award for Distinguished Federal Civilian Service.<\/p>\n<h2>AIDS and the introduction of \u2018User Fees\u2019<\/h2>\n<p>In the 1960s, 1970s, there were social movements in the United States and other developed countries that challenged established norms regarding sexual behavior and relationships. In the 1980s, the AIDS crisis struck the United States and other countries. This prompted government agencies and pharmaceutical firms to dedicate enormous resources to developing new drugs to fight AIDS.<\/p>\n<p><span>With <\/span><span>Celebrities and sports stars die from AIDS-related complications.\u00a0<\/span><a href=\"https:\/\/time.com\/4705809\/first-aids-drug-azt\/#:%7E:text=AZT%2C%20or%20azidothymidine%2C%20was%20originally,mice%20and%20was%20put%20aside.\"><span>AIDS activists<\/span><\/a><span> protested at long delays in receiving FDA-approved HIV drugs. They protested in mass throughout the country, claiming that they had been denied experimental FDA-approved HIV drugs for a long time. <\/span><span>thousands of lives were lost each year due to delays in the FDA\u2019s drug approval process. Protests<\/span><span> And the enormous lobbying done in Congress proved to be very effective.<\/span><\/p>\n<p><span>Congress passed the Prescription Drug User Fee Act, (PDUFA) in 1992. It allows drug manufacturers to pay FDA. \u201cuser fees\u201d To speed up the process of reviewing drug applications.<\/span><\/p>\n<figure id=\"attachment_4893174\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/img.theepochtimes.com\/assets\/uploads\/2022\/11\/29\/GettyImages-1244486456-1200x800.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"lazy size-medium_vertical wp-image-4893174\" src=\"https:\/\/www.theepochtimes.com\/assets\/themes\/eet\/images\/white.png\" data-src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/GettyImages-1244486456-525x350-1.jpg\" alt=\"Epoch Times Photo\" width=\"525\" height=\"350\" \/><figcaption class=\"wp-caption-text\"><noscript><img loading=\"lazy\" decoding=\"async\" class=\"size-medium_vertical wp-image-4893174\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/GettyImages-1244486456-525x350-1.jpg\" alt=\"Epoch Times Photo\" width=\"525\" height=\"350\" \/><\/noscript><\/figcaption><\/a> Fog covers the Capitol Dome, Washington&#8217;s House of Representatives, in the early morning on November 4, 2022. (Samuel Corum\/Getty Images)<\/figure>\n<p>The outcome was significant: The FDA\u2019s new drug review staff <a href=\"https:\/\/www.gene.com\/stories\/a-revolutionary-partnership-the-story-of-pdufa\">Increasing<\/a> This has resulted in a reduction of 50% in the new-application review process and an increase of 33% in the number each year of approved medicines.<\/p>\n<p>Essentially, the PDUFA of 1992 started the FDA\u2019s transformation from providing oversight to providing review services for the drug industry\u2014and from being solely taxpayer-funded to partially industry-funded. The FDA collecting user fees from drug companies is similar to referees receiving lucrative fees from professional sports teams. The FDA pays more for user fees from larger pharmaceutical companies. The FDA is therefore more dependent on these fees to operate, and the more influential they are. \u201cBig Pharma\u201d Companies are.<\/p>\n<p>\u00ad\u00adA peer-reviewed <a href=\"https:\/\/www.bmj.com\/company\/newsroom\/investigation-are-drug-regulators-sufficiently-independent-from-the-companies-they-are-meant-to-regulate\/\">Article<\/a>\u00a0The British Medical Journal, (BMJ) quotes Donald W. Light of Rowan University, New Jersey as saying: \u201cbeing largely funded by fees from the companies whose products it is charged to evaluate is a fundamental conflict of interest and a prime example of institutional corruption.\u201d Light\u00a0has spent decades studying drug regulations.<\/p>\n<h2>Approval Fast-Track \u2018Breakthrough Therapies\u2019<\/h2>\n<p><span>Fr<\/span>From 1993 to 2016, the FDA collected user fees from pharmaceutical companies. <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMhle1710706\">Increased by 300%<\/a>\u2014from around $29 million to $884 million. As the drug makers\u2019 payment to the FDA became larger, so too did their influence over the FDA\u2019s drug approval process.<\/p>\n<p><a href=\"https:\/\/img.theepochtimes.com\/assets\/uploads\/2023\/01\/09\/2023.1.7-user-fee-update.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"lazy aligncenter wp-image-4972868 size-large\" src=\"https:\/\/www.theepochtimes.com\/assets\/themes\/eet\/images\/white.png\" data-src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/2023.1.7-user-fee-update-1200x675-1.jpg\" alt=\"Epoch Times Photo\" width=\"640\" height=\"360\" \/><\/a><\/p>\n<p><noscript><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-4972868 size-large\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/2023.1.7-user-fee-update-1200x675-1.jpg\" alt=\"Epoch Times Photo\" width=\"640\" height=\"360\" \/><\/noscript><\/p>\n<p>The PDUFA was passed in order to accelerate the process. However, the introduction \u201c<a href=\"https:\/\/www.congress.gov\/bill\/112th-congress\/senate-bill\/2236\">Advancing Breakthrough Therapies for Patients Act<\/a>\u201d The 2012 process was simplified. It allows certain drugs to be quickly approved, breaking the traditional drug approval process.<\/p>\n<p>Two criteria are required to qualify a drug for approval \u201cbreakthrough therapy\u201d These are: It is designed to treat serious, life-threatening illnesses. The preliminary clinical evidence suggests that there may be improvements over existing treatments.<\/p>\n<p>Who is the authorized to grant the authorization? \u201cbreakthrough therapy\u201d To be labeled as a new medication? The Secretary of Health and Human Services. The secretary has 60 days from the request of the drug developer to decide whether the drug should be labeled a breakthrough therapy.<\/p>\n<p>In addition, the Secretary of HHS must hire an independent entity to evaluate the FDA\u2019s breakthrough therapy review process and report to Congress on an annual basis.<\/p>\n<figure id=\"attachment_3274446\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/img.theepochtimes.com\/assets\/uploads\/2020\/03\/16\/20180814-Samira_Bouaou-The_Epoch_Times-0A4A9419-1200x800.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"lazy size-medium_vertical wp-image-3274446\" src=\"https:\/\/www.theepochtimes.com\/assets\/themes\/eet\/images\/white.png\" data-src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/20180814-Samira_Bouaou-The_Epoch_Times-0A4A9419-525x350-1.jpg\" alt=\"hhs suffers cyber attack\" width=\"525\" height=\"350\" \/><figcaption class=\"wp-caption-text\"><noscript><img loading=\"lazy\" decoding=\"async\" class=\"size-medium_vertical wp-image-3274446\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/20180814-Samira_Bouaou-The_Epoch_Times-0A4A9419-525x350-1.jpg\" alt=\"hhs suffers cyber attack\" width=\"525\" height=\"350\" \/><\/noscript><\/figcaption><\/a> Washington, August 14, 2018: The Department of Health and Human Services building. (Samirabouaou\/The Epoch Times).<\/figure>\n<p><span>The FDA was established in July 2012 and lasted until December 2015. <a href=\"https:\/\/www.gene.com\/stories\/a-revolutionary-partnership-the-story-of-pdufa\">Approved 40 of the 384<\/a> Breakthrough therapy requests\u00a0<\/span><\/p>\n<p><span>However, \u201cimprovement over existing therapies\u201d This does not necessarily mean that there are no safety or toxicological concerns. The following steps can be used to simplify the process \u201cbreakthrough therapy\u201d Under the umbrella, drugs seeking fast-track approval are often not subject to clinical or preclinical studies that present valid long-term or comprehensive safety and toxicology data. More drug recalls are therefore inevitable. <\/span><\/p>\n<h2>What\u2019s Next?<\/h2>\n<p>A study by (<a href=\"https:\/\/www.bmj.com\/content\/377\/bmj.o1538\">pdf<\/a>) published in The BMJ in June, \u201cin 2020, 68% of\u00a0drug approvals in the United States were through expedited pathways.\u201d New drugs have been approved faster, are more likely be withdrawn from safety, have a black-box warning and have one or more dosage forms that have been discontinued by the manufacturer.<\/p>\n<figure id=\"attachment_3847942\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/img.theepochtimes.com\/assets\/uploads\/2021\/06\/07\/drug-Aduhelm-1200x800.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"lazy size-medium_vertical wp-image-3847942\" src=\"https:\/\/www.theepochtimes.com\/assets\/themes\/eet\/images\/white.png\" data-src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/drug-Aduhelm-525x350-1.jpg\" alt=\"drug Aduhelm\" width=\"525\" height=\"350\" \/><figcaption class=\"wp-caption-text\"><noscript><img loading=\"lazy\" decoding=\"async\" class=\"size-medium_vertical wp-image-3847942\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/drug-Aduhelm-525x350-1.jpg\" alt=\"drug Aduhelm\" width=\"525\" height=\"350\" \/><\/noscript><\/figcaption><\/a> A vial and packaging to be used for Aduhelm, a drug that was approved on June 7, 2021. (Biogen via AP)<\/figure>\n<p><span>In 2021, the FDA gave fast-track approval to the Alzheimer\u2019s drug\u00a0<\/span><a href=\"https:\/\/www.theepochtimes.com\/health\/fda-finally-approved-an-alzheimers-drug-but-everything-surrounding-it-is-controversial_4664303.html\"><span>Aduhelm<\/span><\/a><span>But it is there. \u201cunproven\u201d Many experts, including FDA advisory panel members, were asked to review the Aduhelm application.\u00a0<\/span><\/p>\n<p><span>Pfizer\u2019s COVID-19 vaccine Comirnaty also gained full fast-track approval. There were also numerous scientific reports throughout 2021-2022. <a href=\"https:\/\/www.theepochtimes.com\/health\/serious-adverse-events-and-death-reports-for-major-covid-vaccines-vaers_4918643.html\">patient reports<\/a>Hearings before Congress and the House on safety of this vaccine. What is the potential for long-term harm? It is not surprising that we don&#8217;t know the long-term effects of this.\u00a0\u00a0<\/span><\/p>\n<figure id=\"attachment_4630093\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/img.theepochtimes.com\/assets\/uploads\/2022\/07\/1.tagreuters.com2022binary_LYNXMPEI6R0EO-FILEDIMAGE-1-1200x794.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"lazy size-medium_vertical wp-image-4630093\" src=\"https:\/\/www.theepochtimes.com\/assets\/themes\/eet\/images\/white.png\" data-src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/1.tagreuters.com2022binary_LYNXMPEI6R0EO-FILEDIMAGE-1-529x350-1.jpg\" alt=\"1.tagreuters.com2022binary_LYNXMPEI6R0EO-FILEDIMAGE-1\" width=\"529\" height=\"350\" \/><figcaption class=\"wp-caption-text\"><noscript><img loading=\"lazy\" decoding=\"async\" class=\"size-medium_vertical wp-image-4630093\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2023\/01\/1.tagreuters.com2022binary_LYNXMPEI6R0EO-FILEDIMAGE-1-529x350-1.jpg\" alt=\"1.tagreuters.com2022binary_LYNXMPEI6R0EO-FILEDIMAGE-1\" width=\"529\" height=\"350\" \/><\/noscript><\/figcaption><\/a> Vials of the Pfizer-BioNTech Comirnaty COVID-19 vaccine are pictured in a general practitioner\u2019s practice in Berlin, Germany, on April 10, 2021. (Fabrizio Bensch\/Reuters)<\/figure>\n<p><span>In October 2022, the U.S. Congress reauthorized the PDUFA for the sixth consecutive time. But when the PDUFA changed the relationship between the FDA and the drug companies, it also changed the FDA\u2019s relationship with taxpayers. Is the FDA able to protect taxpayers if a large part of its budget comes directly from Big Pharma? Is the end in sight for the endless cycle of new drugs being approved and recalled drugs?\u00a0<\/span><\/p>\n<p><span>The history has repeatedly shown us that people make foolish decisions that can cause injury to themselves and others for the greater good. A new law that challenges the PDUFA status is definitely warranted. The question is, who will be able to introduce it?\u00a0<\/span><\/p>\n<p><i>The opinions expressed in this article do not necessarily reflect those of The Epoch Times. Epoch Health encourages professional discussion and friendly debate. Follow these guidelines to submit your opinion piece. <a href=\"https:\/\/www.theepochtimes.com\/submission-guidelines_4553495.html\" target=\"_blank\" rel=\"noopener\">Use our form below<\/a>.<\/i><\/p>\n<div class=\"author_wrapper\">\n<div class=\"one_author_block round\">\n<div class=\"top_row\">\n\t\t\t\t\t<a href=\"https:\/\/www.theepochtimes.com\/author-xiaoxu-sean-lin\"><img decoding=\"async\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/10\/WEB_SeanLin.jpg\" alt=\"Dr. Sean Lin\" \/><\/a>\n\t\t\t\t\t<\/div>\n<p>Dr. Xiaoxu Sean Lin, an assistant professor in Biomedical Sciences Department at Feitian College \u2013 Middletown NY.   Lin is also an analyst for Epoch Media Group and VOA.  Dr. Lin was a U.S. Army microbiologist.  Dr. Lin also belongs to Committee of Present Danger: China.  <\/p>\n<\/p><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Federal Food and Drug Administration\u2019s (FDA)\u00a0Origins The 1906 Pure Food and Drugs Act was the first act that established the federal consumer protection agency. However, its foundation was not enough to stop low-quality food and drugs from flooding the market. In 1938, Congress passed the Food, Drug, and Cosmetic Act, in response to &hellip;<\/p>\n","protected":false},"author":1,"featured_media":1801925,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[547],"tags":[5458,5642,8468,4759,3819,7257],"class_list":["post-1801922","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-bongino-report","tag-bongino","tag-drug","tag-fda","tag-makers","tag-report","tag-users"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1801922","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1801922"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1801922\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/1801925"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=1801922"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1801922"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1801922"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}