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display:inline-block;">Published by: <a href="http://pharmacychecker.com/" target="_blank"" data-wpel-link="external" rel="external noopener noreferrer"><img src="/wp-content/uploads/2010/02/PharmacyCheckerLogo1-e1265422209602.gif" /></a> </div> </div> </div> </div> </div> <header id="main-header" data-height-onload="30"> <div class="container clearfix et_menu_container"> <div id="et-top-navigation" data-height="30" data-fixed-height="40"> <nav id="top-menu-nav"> <ul id="top-menu" class="nav"><li id="menu-item-7156" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-7156"><a href="https://pharmacycheckerblog.com/topics" data-wpel-link="internal">Topics</a></li> <li id="menu-item-1732" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-1732"><a href="https://pharmacycheckerblog.com/about" data-wpel-link="internal">About</a></li> <li id="menu-item-2770" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-2770"><a href="https://pharmacycheckerblog.com/privacy-policy" data-wpel-link="internal">Privacy Policy</a></li> </ul> </nav> <div id="et_mobile_nav_menu"> <div class="mobile_nav closed"> <span class="select_page">Select Page</span> <span class="mobile_menu_bar mobile_menu_bar_toggle"></span> </div> </div> </div>  </div>  <div class="et_search_outer"> <div class="container et_search_form_container"> <form role="search" method="get" class="et-search-form" action="https://pharmacycheckerblog.com/"> <input type="search" class="et-search-field" placeholder="Search …" value="" name="s" /> </form> <span class="et_close_search_field"></span> </div> </div> </header>  <div id="et-main-area"> <div id="main-content"> <div class="container"> <div id="content-area" class="clearfix"> <div id="left-area"> <article id="post-7581" class="et_pb_post post-7581 post type-post status-publish format-standard has-post-thumbnail hentry category-drug-safety-2 tag-bayer tag-donald-trump tag-katherine-eban tag-roger-bate"> <div class="et_post_meta_wrapper"> <h1 class="entry-title">Trump’s Pakistani Imported Chloroquine Phosphate: FDA Inspections vs. EU Testing to Ensure Drug Safety</h1> <p class="post-meta"> by <span class="author vcard"><a href="https://pharmacycheckerblog.com/author/admin" title="Posts by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice" rel="author" data-wpel-link="internal">Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice</a></span> | <span class="published">May 1, 2020</span> | <a href="https://pharmacycheckerblog.com/category/drug-safety-2" rel="category tag" data-wpel-link="internal">Drug Safety</a> | <span class="comments-number"><a href="https://pharmacycheckerblog.com/trumps-pakistani-imported-chloroquine-phosphate-fda-inspections-vs-eu-testing-to-ensure-drug-safety#respond" data-wpel-link="internal">1 comment</a></span></p><img width="1080" height="360" src="https://pharmacycheckerblog.com/wp-content/uploads/2020/05/drug-testing.png" class="et_featured_image w-100 wp-post-image" alt="drug testing" title="Trump’s Pakistani Imported Chloroquine Phosphate: FDA Inspections vs. EU Testing to Ensure Drug Safety" decoding="async" fetchpriority="high" srcset="https://pharmacycheckerblog.com/wp-content/uploads/2020/05/drug-testing-980x327.png 980w, https://pharmacycheckerblog.com/wp-content/uploads/2020/05/drug-testing-480x160.png 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw" /> </div>  <div class="entry-content" style="padding-top: 0;"> <p>In late March, drug giant Bayer Pharmaceuticals, out of the goodness of its heart, agreed to donate three million tablets of chloroquine phosphate to help the Trump administration get this drug into U.S. pharmacies. That’s according to an investigative article in <em>Vanity Fair</em> by Katherine Eban, called:</p> <p><strong>“‘</strong><a href="https://www.vanityfair.com/news/2020/04/internal-documents-reveal-team-trumps-chloroquine-master-plan" data-wpel-link="external" rel="external noopener noreferrer"><strong>Really Want to Flood NY and NJ’: Internal Documents Reveal Team Trump’s Chloroquine Master Plan”</strong></a></p> <p>How inflammatory?! For Trump lovers, that title has the ring of just more biased, liberal media Trump-bashing. For Trump haters, it’s another reason to hate Trump. This post isn’t about our constant partisan divide or even Bayer or other evil drug companies, although they are referenced. It’s also not about unproven treatments for Covid-19 (that was <a href="https://pharmacycheckerblog.com/counterfeit-chloroquine-doesnt-treat-covid-19-does-genuine-chloroquine" data-wpel-link="internal">last week</a>). All parties should be interested in the story behind the story: <em>independent drug testing</em> and its potential importance to determine if a drug is safe and effective.  </p> <p>I’m a big fan of testing prescription drugs to see if they have the right stuff (to put it eloquently). Here’s why: lots of <a href="https://tarbell.org/2018/05/keeping-international-pharmacies-under-a-cloud/" data-wpel-link="external" rel="external noopener noreferrer">pharma-funded groups</a> and some people at the <a href="https://tarbell.org/2018/07/fda-boss-confirms-opioid-crackdown-is-aimed-at-cheaper-prescriptions-too/" data-wpel-link="external" rel="external noopener noreferrer">FDA</a> say don’t buy medicine online from foreign countries because it’s allegedly unsafe. Yet, independent testing of about a thousand prescription drug orders has shown that <a href="https://www.aei.org/research-products/report/personal-medicine-importation-what-are-the-risks-and-how-can-they-be-mitigated/" data-wpel-link="external" rel="external noopener noreferrer">personal drug importation can and is done very safely</a>. Periodic testing of foreign online pharmacy medication orders over the last decade has proven the efficacy of brand name Celebrex, Lipitor, Nexium, Viagra and Zoloft; generic ciprofloxacin and atorvastatin; and, just last month, hydroxychloroquine and chloroquine phosphate.</p> <span id="more-7581"></span> <p>The results?</p> <p>If you choose to buy from PharmacyChecker-accredited sites (or other organizations and companies that properly credential online pharmacies), you will get the right drug, according to the aforementioned testing.</p> <p>If you don’t, then you’re much more likely to get a counterfeit or otherwise substandard drug. Peer-reviewed journals are so convinced of this safety that they are <a href="https://www.aei.org/health-care/catch-22-credentialed-online-pharmacies-are-so-safe-that-peer-review-literature-is-no-longer-interested-in-results-showing-it/" data-wpel-link="external" rel="external noopener noreferrer">not interested</a> in similar studies.</p> <p>Now, the lead scholar and policy wonk on the online pharmacy testing is Roger Bate, PhD, an economist affiliated with the American Enterprise Institute who specializes in drug quality and public health. I have never given a penny to AEI and, honestly, disagree with their policy positions on almost all issues. So, hey, it’s pretty convenient that I agree with Mr. Bate about his online pharmacy drug testing! But my belief extends to testing that has nothing to do with online pharmacies. We need to do more of it now.</p> <p>The FDA has recently <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-disease-2019-covid-19-update-foreign-inspections" data-wpel-link="external" rel="external noopener noreferrer">suspended</a> its overseas inspections of drug establishments that manufacture products for the U.S. market. Albeit there are some new hellish supply chain issues due to the coronavirus, drug importation from those plants is still happening. Mr. Bate extols the FDA’s relative capacity to inspect drug manufacturing plants to help ensure they are operating in accordance with Good Manufacturing Practices, crediting the agency with finding problems at plants more than its foreign counterparts.</p> <p>On the other hand, countries of the European Union rely more on quality testing of drug imports than on inspections – and it does a better job than the U.S. In view of the fact that the FDA can’t inspect overseas, <a href="https://www.aei.org/health-care/covid-19-and-drug-quality-uncertainty-what-to-do-about-it/" data-wpel-link="external" rel="external noopener noreferrer">Mr. Bate recommends independent testing</a> – like they have in the European Union. You see, we have testing in the U.S., but it’s based on the honor system: trusting the drug companies to test their own products. Really – the honor system. Mr. Bate writes:</p> <p>“In the EU, this certification has to be provided by a EU qualified person, meaning a EU citizen. But we don’t have that system here. Instead, we essentially use an honor system from the manufacturer. Many manufacturers have not always acted honorably, so the system doesn’t work too well. Today, the way it works for the most duplicitous firms is that even if they find that the product they are shipping fails microbial contamination testing for example, they just make up data on the CoA and ship it anyway.”</p> <p>One of the reasons he knows all about this is from talking to celebrity whistleblower Dinesh Thakur and getting his advice. Mr. Thakur blew the whistle on criminal and dangerous acts by Indian drug company Ranbaxy. One such act was falsifying manufacturing and testing data. Essentially, the honor system doesn’t always work when it comes to be drug companies (who knew?). For more details on what Bate and Thakur are recommending: <a href="https://www.aei.org/health-care/covid-19-and-drug-quality-uncertainty-what-to-do-about-it/" data-wpel-link="external" rel="external noopener noreferrer">read this post</a>. But the gist is really to create requirements for independent labs to test imported drug products at the batch level. I bet people think we do that already.</p> <h2 class="wp-block-heading">So, how does this relate to Trump-love for chloroquine phosphate, Bayer Pharmaceuticals and Pakistan?</h2> <p>Back in mid-March, before the publicity, Trump was bullish on chloroquine meds. The administration set about trying to increase our emergency supply, which led to an outreach from the lovable Bayer. Bayer said it would donate the drugs. That’s easy to corroborate because the drug company bragged about it in a <a href="https://eyewire.news/articles/bayer-partners-with-u-s-government-on-major-product-donation-to-fight-coronavirus/" data-wpel-link="external" rel="external noopener noreferrer">press release</a>:</p> <p>“Bayer announced it is joining the U.S. Government’s fight against COVID-19 with a donation of 3 million tablets of the drug Resochin (chloroquine phosphate)… Bayer in recent days has been in talks with the White House, HHS, CDC, and the FDA, offering any assistance we can provide with a focus on donating Resochin to help in the government’s efforts to combat the virus.”</p> <p>Gives you the warm fuzzies. [An aside: I still hope these anti-malaria drugs pan out for Covid-19, but it doesn’t look good from the <a href="https://www.sciencemag.org/news/2020/04/antimalarials-widely-used-against-covid-19-heighten-risk-cardiac-arrest-how-can-doctors" data-wpel-link="external" rel="external noopener noreferrer">recent data</a>. The FDA is wisely <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or" data-wpel-link="external" rel="external noopener noreferrer">cautioning people</a> against trying to get this medicine for themselves without medical supervision.]</p> <p>Bayer’s “pat-on-the back” press release did not mention where Resochin is made. It’s made in Pakistan. As readers of my epistolary and <a href="https://www.pharmacychecker.com/news/fdas-drug-importation-data-is-wrong/" data-wpel-link="external" rel="external noopener noreferrer">research efforts</a> know, I can’t get enough of talking about how “American drugs” are anything but since most drugs sold in U.S. pharmacies are imported. But not Resochin: Bayer’s beautiful chloroquine pills have <em>never</em> been sold in the United States. Why not? Ms. Eban points out that “normally [its importation] would be prohibited since the FDA had never inspected the plant in Karachi, Pakistan, where Resochin is made.” As it happens, FDA inspections of foreign drug establishments are not required by the FDA as a basis for importing pharmaceuticals: we have an increasing number of <a href="https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra" data-wpel-link="external" rel="external noopener noreferrer">mutual recognition agreements</a> with countries through which we rely on their drug regulatory authority inspections. Pakistan is not one of those countries.</p> <h2 class="wp-block-heading">How can the FDA check safety where it can’t inspect or rely on the inspections of other regulatory authorities?</h2> <p>In the case of Bayer’s Resochin, Eban reports: “…the FDA set aside its usual safeguards and approved the donation, after <strong>sampling and testing</strong> the drugs to make sure they met U.S. standards.”</p> <p>Roger Bate and Dinesh Thakur are recommending that we do more such testing for drug imports for sale in the commercial U.S. market since we are not doing inspections now. But as far as I see it, we should simply be doing more independent testing even in the absence of a global pandemic. Katherine Eban’s book Bottle of Lies: The Inside Story of  the Generic Drug Boom was scathing in its criticism of FDA drug inspections – overly so in <a href="https://pharmacycheckerblog.com/bottle-of-lies-author-katherine-eban-dispense-as-written" data-wpel-link="internal">my opinion</a> – but a great book nonetheless for exposing all that is wrong with the drug safety system. Mr. Bate’s appreciation for FDA inspections compared to other drug regulatory authorities is well placed, but the FDA has made many mistakes and even intentionally overlooked lapses in drug manufacturing. All the more reason to test, test, test.</p> <p>To add irony in concluding this post: two fun facts.</p> <ol class="wp-block-list" type="1"><li>Federal law actually calls for more stringent testing of imported, lower-cost Canadian drugs, per the FDA’s proposed rule to implement Section 804. See <a href="https://www.regulations.gov/document?D=FDA-2019-N-5711-1221" data-wpel-link="external" rel="external noopener noreferrer">Horvath Health Policy public comments on Section 804 importation</a>. In other words, if the U.S. moves forward to permit wholesale drug importation from Canada, because of supplemental testing requirements, those imported cheaper drugs may have greater safety guarantees!</li></ol> <ul class="wp-block-list"><li>Since the pandemic, the FDA has been seizing more medicines personally imported through international mail facilities by Americans <a href="https://pharmacycheckerblog.com/fda-seizures-of-mail-order-prescriptions-increase-in-the-time-of-coronavirus" data-wpel-link="internal">trying to afford their meds</a>. The FDA’s announcement about suspending inspections of foreign drug establishments does not mention more independent testing in the pipeline but references that sample testing can be a basis to refuse drug imports! FDA boss Stephen M. Hahn M.D. states:</li></ul> <p>“We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.”</p> <p>Well, they have been good at <a href="https://pharmacycheckerblog.com/fda-seizures-of-mail-order-prescriptions-increase-in-the-time-of-coronavirus" data-wpel-link="internal">seizing safe and effective</a> drugs that “<strong>may</strong> violate other applicable legal requirements;” testing, not so much.</p> <div class="addtoany_share_save_container addtoany_content addtoany_content_bottom"><div class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="https://pharmacycheckerblog.com/trumps-pakistani-imported-chloroquine-phosphate-fda-inspections-vs-eu-testing-to-ensure-drug-safety" data-a2a-title="Trump’s Pakistani Imported Chloroquine Phosphate: FDA Inspections vs. EU Testing to Ensure Drug Safety"><a class="a2a_dd addtoany_share_save addtoany_share" href="https://www.addtoany.com/share" data-wpel-link="external" rel="external noopener noreferrer"><img src="https://static.addtoany.com/buttons/share_save_256_24.png" alt="Share"></a></div></div>Tagged with: <a href="https://pharmacycheckerblog.com/tag/bayer" rel="tag" data-wpel-link="internal">Bayer</a>, <a href="https://pharmacycheckerblog.com/tag/donald-trump" rel="tag" data-wpel-link="internal">Donald Trump</a>, <a href="https://pharmacycheckerblog.com/tag/katherine-eban" rel="tag" data-wpel-link="internal">Katherine Eban</a>, <a href="https://pharmacycheckerblog.com/tag/roger-bate" rel="tag" data-wpel-link="internal">Roger Bate</a><br /> </div>  <div class="et_post_meta_wrapper" style="padding-bottom: 30px;"> <section id="comment-wrap"> <h1 id="comments" class="page_title">1 Comment</h1> <ol class="commentlist clearfix"> <li class="comment even thread-even depth-1" id="li-comment-251439"> <article id="comment-251439" class="comment-body clearfix"> <div class="comment_avatar"> </div> <div class="comment_postinfo"> <span class="fn">J. M.</span> <span class="comment_date"> on February 11, 2024 at 3:36 am </span> </div> <div class="comment_area"> <div class="comment-content clearfix"> <p>I’m 3 1/2 years behind this article, but feel it’s even more valid now. This admin. has made it very clear they’ve weaponized every abc organization in the govt. That said, in drug testing, don’t count on it. The realization of the poisonous jab they forced onto the population has more than solidified their resolve in putting anything out that takes lives. Their depopulation agenda is growing in leaps and bounds! Why would they spend that extra money to test, aside maybe to continue to deceive the population to purchase the drugs that kill, rather than heal?! The endless side effects of each synthetic medication WILL eventually kill or at minimum, maime. The more money they can pocket while doing so is the side effect to depopulation. Make no mistake, that goal is there! Ask yourself why Fauci and his minions would work so hard to discredit and suppress that hydroxychloroquine and ivermectin WORK?! Hundreds of thousands of people were SAVED using those products! No! They pushed a drug that studies had PROVEN shuts organs down! Remdesivir. And it did just that to these poor folks on vents! Yet, they said it was the ONLY thing to work? They killed those patients it was used on! Said it was the virus, not the drug! Genocide! World wide genocide. Nothing short of that. Another plandemic is in the works and has been during the first. Please….read the many many doctors publications on Substack. Dr. Ana Milhacea being an excellent start. Discover the truth! Discover what the bio weapons are and what’s subsequently in the poison being injected into trusting people. I pray SOMEONE will see this and go read! Sit down first before reading. Just like “climate warming”, it’s one of top five largest hoax perpetuated on the people in this world! And there WILL be hell to pay! Hell.</p> <span class="reply-container"><a rel="nofollow" class="comment-reply-link" href="https://pharmacycheckerblog.com/trumps-pakistani-imported-chloroquine-phosphate-fda-inspections-vs-eu-testing-to-ensure-drug-safety?replytocom=251439#respond" data-commentid="251439" data-postid="7581" data-belowelement="comment-251439" data-respondelement="respond" data-replyto="Reply to J. M." aria-label="Reply to J. 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Richard Burr’s Love Affair with Big Pharma: The Ghost of Billy Tauzin</a> </li> </ul> </div><div id="text-3" class="et_pb_widget widget_text"><h4 class="widgettitle">Groups Showing Support for Personal Drug Importation</h4> <div class="textwidget"><p><a href="http://www.ncpssm.org//" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">National Committee to Preserve Social Security and Medicare</a><br /> <a href="http://www.retiredamericans.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">Alliance for Retired Americans</a><br /> <a href="http://www.rxrights.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">RxRights</a><br /> <a href="http://www.nfib.com/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">National Federation of Independent Business</a><br /> <a href="http://www.aafp.org/online/en/home.html" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">American Academy of Family Physicians</a><br /> <a href="http://nrln.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">National Retiree Legislative Network</a><br /> <a href="http://www.nea.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">National Education Association</a><br /> <a href="http://nfu.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">National Farmers Union</a><br /> <a href="http://www.tpfc.net/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">Telephone Pioneer Family Campers</a><br /> <a href="https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=283" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">American Association of Health Freedom</a><br /> <a href=" http://personalimportation.org/" target="_blank" data-wpel-link="internal">Campaign for Personal Prescription Importation</a><br /> <a href="http://mvmn.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">Mature Voices Minnesota</a><br /> <a href="http://www.demandprogress.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">Demand Progress</a><br /> <a href="http://www.cwag.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">Coalition of Wisconsin Aging Groups</a><br /> <a href="http://www.seniors.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">Congress of California Seniors</a><br /> <a href="http://www.todaysseniorsnetwork.com/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">TodaysSeniorsNetwork</a><br /> <a href="http://www.cipa.com/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">CIPA</a><br /> <a href="http://www.pharmacy-accreditation-services.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">Pharmacy Accreditation Services</a><br /> <a href="http://www.nysenior.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">New York StateWide Senior Action Council</a><br /> <a href="http://www.thirdagepower.org/" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">Third Age Power</a></p> <p><a href="http://online-pharmacy-and-prescription-drug-review.com/contact-us" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">Let us know</a> of others.</p> <p>Source: <a href="http://www.govtrack.us/congress/bill.xpd?bill=s111-525" target="_blank" data-wpel-link="external" rel="external noopener noreferrer">www.govtrack.us</a></p> </div> </div><div id="tag_cloud-3" class="et_pb_widget widget_tag_cloud"><h4 class="widgettitle">Tags</h4><div class="tagcloud"><a href="https://pharmacycheckerblog.com/tag/aarp" class="tag-cloud-link tag-link-52 tag-link-position-1" style="font-size: 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