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FDA questions quality of life improvement claims for drugs known as ESA's or erythropoiesis-stimulating agents, which are the drugs Epogen and Aranesp of Amgen and procrit by J&J.

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Medications that are appropriate for certain subgroups of patients and a case for approving medications with the target subgroup in mind.

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FDA's approach to Eli Lilly's drug Prasgrel which is more effective than Plavix for preventing heart attacks but can lead to fatal bleeding in some patients. The other side of the picture is that 30% of patients are not suited for Plavix, and these patients could have an alternative. In weighing the risks and the benefits, and of letting some patients who may be suited to Prasugrel have access to the drug, the FDA has to find the right approach. An FDA panel was set to recommend whether to approve the drug and under what conditions.

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Analysis of its findings in the WSJ story on August 18 shows the FDA unnecessarily delayed private labs from developing and using their own tests from Feb 9 when FDA test for coronavirus failed for its third component. The FDA said it would correct the flaws but repeatedly failed to do so until it finally allowed private labs to go ahead on their own- a costly delay of 3 weeks that made the test and contact trace strategy inoperable, because the time window was lost in those 3 critical weeks. In March through August the pandemic has now taken up about 5 million cases in the U.S. and 170,000 deaths, with no end in sight. During times like these and in a swiftly moving current of a river such as the time of a pandemic, the  teaching hospital labs and labs with resources and scientific reputation with their lightning speed have to have the freedom  to immediately respond. In this case the FDA should have released the private labs of teaching hospitals and the the highly reputable labs of well known medical companies to immediately start developing their own tests and using them, starting  on Feb. 10 the day after it was evident that the FDA test's third component was not working. ...

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Continued slowdown in Avandia sales. FDA experts continue to be critical of Glaxo studies on Avandia.

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Chris Klomp, 45 years, takes over at 65,000 person $2.6 trillion government agency, Department of Health and Human Services, as Counselor, as Robert Kennedy Jr. heads for the campaign trail in addition to HHS duties March 12 2026. He impressed DJT with his negotiating ability against the drug companies in the government's efforts on Affordability of medicines. DJT calls him "my favorite Mormon." Susie Wiles was looking for a stabilizing force at HHS after vaccine controversies and wants the message to focus on improving health and cutting costs. Robert Kennedy Jr says about Klomp- "He is moving quickly to impose operational discipline, sharpen our strategic direction, and fortify a renewed sense of mission and accountability.” Klomp is pulling together all the agencies under HHS including FDA and others. Klomp takes his role seriously to cut costs and improve Health- .“In health care in particular, I do believe that I’m my brother’s keeper, and our job is to do the very best that we can for the people that we serve — the American people.” ...

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The FDA has handled the importation of masks from China badly says this report in WSJ. During the shortage FDA let 3500 Chinese manufacturers selling products of wide variations in quality to send masks to the U.S. Millions of these N95 masks are now available imported from China but their reliability is uncertain. The FDA even has the same manufacturers on approved and revoked approval lists creating more confusion. The FDA gave then revoked approval for products that failed quality standards.  The WSJ found that some of the companies given approval early were just weeks old and had not completed quality review by FDA. The WSJ reports that more than 60% of foreign made masks nearly all Chinese made failed basic U.S. government quality tests that reviewed 22 brands according to regulatory data. About one fifths of the makers were just weeks old and others made claims that were simply not correct. The FDA acted in a crisis situation so bad actors could take advantage of the situation say experts.  What happens now. The states of California,Washington and Texas are now checking their supplies of N95 masks to see if all the makers are on authorized lists and not revoked. Many doctors and hospitals are going through much anxiety because of the safety of their N95 masks in close contact situations in eyecare, dental care and other care, is now uncertain. ...

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The FDA approves Governor De Santis proposal for importing drugs from Canada. Colorado is one of the other states that have applied. The drugmakers continue their opposition even if this means lower prices for the American people of excessively higher priced American drugs compared to other countries. Both Republicans and Democrats agree prices have to come down and support importing of drugs into the US, then why is it taking so long for the FDA  to approve state proposals? The Biden administration has issued an executive order for the FDA to work with states on this.

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US foreign direct investment to China goes down 40% in 2020 to 2022 compared to the period 2015 to 2020, for India this was up by 20%, according to IMF. India was the only G-20 country that received this level of foreign direct investment. Prashant Jha of the Hindustan Times correctly points out that the IMF paper and the model on which this paper is based are flawed. The paper sees countries based on alignment and India as a so called non aligned country not part of friendshoring, even though Treasury Secretary Janet Yellen has openly called for friendshoring in India alongside finance minister Nirmala Sitharaman. IMF experts have not caught up to Mr. Biden's remarks about the US- India relationship that it would be "the closest on earth." Closer even than America's relationship with Britain or Europe. On oil imports Biden and Jake Sullivan believe that after the pandemic India should import oil at the lowest possible cost to meet the long time denied aspirations of 1.2 billion people, and build the infrastructure that will make it a critical part of America's new supply chain. Every time there are military drills and blockade of Taiwan by China the people of America are moving a step further away from American companies that have overconcentration of manufacturing in China and closer to calling for a new supply chain that reduces concentration in China and builds new manufacturing in India.  ...

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"Woke" was overrated to begin with. Older people agreed to go along not out of conviction but because some younger people took to it. As "nice" people people went along with whatever the prevailing wind was blowing one way or the other. It never had any roots going through complacency, conformity for a while, then apathy, followed by loss of attention or interest. Lost as the winds change directions.

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There are serious serious flaws with the FDA regulations for weight loss pills and dietary supplements. THe law enacted in 1994 gives the FDA jurisdiction only after the pills go on the market whereas for drugs they get reviewed first. THe re is only aspot checking of manufacturers and distributors once the pills are on the dshelves or on the internet. THe FDA believes there may be hundreds of contaminated weight loss diet supplements. Says Michael Levy director of the FDA's deivision of New Drugs and Labeling Compliance, alarge percentage of these products contain dangerous undeclared ingredients. Even after the products are on the market the FDA does not have thability to remove pills from stores, initially the law allows that its upto the companies to issue arecall. It is only eventually that the FDA can act and it does not have the resources to deal with this problem. This even though these ingredients can cause heart atttacks, seizures, and all kinds of health problems. About $27 billion are spent on dietary supplement, $1.7 billion on weight loss pills, and 15% of the population say they have used weight loss supplements, and most have not told their doctors about it. ...

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Drug marketing and sales, especially advertising of drugs on TV and in promotional information is being viewed as suspect in different parts of the environment - the consumers, the public, FDA etc.

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The Nation's Healthcare takes a huge hit in August 1997 by opening up television to a surge of drug ads. The president is Bill Clinton who reappointed Bush appointment Kessler as the Food and Drug Administration chief 1990-1997. DJT and RFK Jr. are finally tackling issues the Bush and Clinton/Obama Republicans and Democrats failed to bring up or address for the Nation's Health.