Tennessee Receives First Shipment of COVID-19 Vaccine, But No Doses Administered

A first shipment of 975 doses of the Pfizer-BioNTech COVID-19 vaccine arrived in Tennessee on Monday, but there are no plans to administer the vaccine until larger shipments arrive to hospitals on Thursday.

Instead, the early shipment of the vaccine will be held “as an emergency backup supply, should any receiving hospital’s supply be damaged,” the Tennessee Department of Health announced Monday.

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Governor Mike DeWine Warns Ohioans to Watch Hospital Capacity as Health Director Mulls Outpatient Treatments for COVID-19

During the Thursday COVID briefing, Ohio Governor Mike DeWine said that he “took an oath to do everything to protect the lives and wellbeing of fellow Ohioans” and that the next three weeks will be the most critical in battling COVID.

DeWine then stressed the importance of Ohioans understanding and keeping an eye on hospital capacity in their respective communities.

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FDA Grants Pfizer Coronavirus Vaccine Emergency Authorization, Launching Nationwide Distribution and Vaccination Effort

The FDA approved Pfizer’s coronavirus vaccine for emergency use Friday, officially beginning a nationwide mass vaccination effort in an attempt to overcome the coronavirus pandemic.

Its approval follows a key FDA panel’s overwhelming vote to endorse the vaccine’s safety and efficacy. President Donald Trump called for the agency to approve Pfizer’s earlier Friday, telling its director, Dr. Stephen Hahn, to “get the dam vaccines out” as soon as possible.

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FDA Advisory Panel Approves Pfizer Coronavirus Vaccine, Clearing Way for Final Authorization and Distribution

The FDA’s vaccine advisory panel voted 17-4 to approve Pfizer’s coronavirus vaccine for use, clearing the way for its approval and distribution nationwide.

After scouring over Pfizer’s data during the multi-hour meeting Thursday, the panel ensured that it was safe for the hundreds of million Americans expected to receive it in the coming months and voted to recommend approval. Though the panel’s decision is merely an advisory one, the FDA is expected to heed its recommendation and approve Pfizer’s vaccine as early as Friday.

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Moderna Asks FDA for Emergency Approval of COVID-19 Vaccine, Second Company to Pass Milestone

Pharmaceutical company Moderna announced Monday that it will submit its coronavirus vaccine to the federal government for emergency use authorization approval.

Moderna said it would ask the Food and Drug Administration (FDA) for approval after its large-scale human trial concluded and showed the company’s vaccine to have an overall efficacy of 94.1%, according to NBC News. The vaccine was found to be 100% effective in preventing severe cases of coronavirus, according to Moderna.

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Pfizer Chooses Tennessee as One of Four States for COVID-19 Vaccine Distribution Pilot Program

Tennessee is one of four states chosen by pharmaceutical giant Pfizer to help refine plans for the delivery and deployment of the Pfizer-BioNTech COVID-19 vaccine if it receives approval from the U.S. Food and Drug Administration, Pfizer announced Tuesday.

The pilot program will help support states’ planning, deployment and administration of the COVID-19 vaccine and adapt findings for use in other states to support vaccine distribution. Tennessee released its COVID-19 vaccine distribution plan last month.

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FDA Has Delayed Approval Process for Promising Cancer Drug for Months Because of COVID

A promising immunotherapy drug for patients battling non-Hodgkin’s lymphoma may fail to gain federal approval due to COVID-19 precautions, according to company executives and a quarterly report.

Liso-cel, manufactured by Bristol-Myers Squibb, originally had its Food and Drug Administration (FDA) application accepted in February, but has yet to have one of its contracted manufacturing sites undergo FDA inspection due to the coronavirus pandemic. Not only is the drug’s approval contingent on the facility inspections from the FDA, according to multiple company executives, but its application expires on Nov. 16, meaning that if the plant is not inspected in the coming days Bristol-Myers may have to completely resubmit the drug’s application as a result.

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AstraZeneca, Johnson and Johnson Resuming U.S. Tests of COVID-19 Vaccines

Two drugmakers announced Friday the resumption of U.S. testing of their COVID-19 vaccine candidates.

Testing of AstraZeneca’s vaccine candidate had been halted since early September, while Johnson & Johnson’s vaccine study was paused at the beginning of last week. Each company had a study volunteer develop a serious health issue, requiring a review of safety data.

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White House to Block FDA Vaccine Guidelines That Would’ve Delayed Approval Past Election

The White House blocked new vaccine guidelines proposed by health officials within the Trump administration, which likely would have pushed the approval of a coronavirus vaccine past the election.

The Food and Drug Administration (FDA), which is in charge of approving vaccines, proposed the guidance on Sept. 21, according to The New York Times. White House chief of staff Mark Meadows raised concerns with one provision of the guidelines which said vaccine trial subjects should be examined for two months following their final dose, a senior administration official told the Times.

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NIH: Halted Vaccine Study Shows ‘No Compromises’ on Safety

The suspension of a huge COVID-19 vaccine study over an illness in a single participant shows there will be “no compromises” on safety in the race to develop the shot, the chief of the National Institutes of Health told Congress on Wednesday.
AstraZeneca has put on hold studies of its vaccine candidate in the U.S. and other countries while it investigates whether a British volunteer’s illness is a side effect or a coincidence.

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Commentary: Lowering the Cost of Prescription Medicines for Seniors Is Not Impossible

Earlier this year James Payne, a 73-year-old retired attorney in Utah, was so fed up with the high cost of a blood thinner medication he takes, he researched prices in Canada, where he found it was cheaper.

“Under Medicare, I am now paying $225 for a three-month supply,” Payne explained. “That’s $25 more than I was paying last year. Under my employer’s insurance I was only paying $20.” Payne says he is not sure why the costs are so much higher and continue to climb under Medicare, but he thinks there must be ways to make life-saving medications more affordable.

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President Trump Announces Plasma Treatment Authorized for COVID-19

President Donald Trump announced Sunday the emergency authorization of convalescent plasma for COVID-19 patients, in a move he called “a breakthrough,” one of his top health officials called “promising,” and other health experts said needs more study before it’s celebrated.

The announcement comes after days of White House officials suggesting there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease that has upended Trump’s reelection chances.

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Trump’s Sunday Presser Forces Hand of Ohio’s Dept of Health and Governor DeWine

President Donald J. Trump announced the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for convalescent plasma as a therapeutic treatment in COVID patients Sunday.

Convalescent plasma is the liquid part of the blood that contains COVID antibodies. Convalescent plasma given to COVID patients during research conducted since April by the Mayo Clinic has resulted in a 35% decrease in the incidence of death in the patients receiving the plasma, according to FDA Director Stephen Hahn.

The announcement is significant in Ohio where Republican Governor Mike DeWine has hinted for months at his hesitation to allow Ohioans to return to normal life until there is a vaccine.

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Minnesota Lifts Statewide Ban on Hydroxychloroquine

Governor Walz lifted the restrictions on access to hydroxychloroquine, a drug that has been in use for decades to treat a wide variety of illnesses – including SARS-type infections – that some say may be an effective therapeutic for COVID-19. The removal of limitations on the drug were outlined in Walz’s latest executive order issued last week.

Walz did not give an explanation for the reversal of his order on the drug.

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Ohio Regulators Ban, Then Un-Ban ‘Controversial’ COVID Drug

The Ohio Pharmacy Board (OPB) implemented – then quickly reversed – a ban on the use of hydroxychloroquine Thursday. The move followed a revocation of the emergency use authorization by the FDA earlier this month. Previously, President Trump said the decades-old drug could be used as a preventative treatment for a deadly symptom of the disease that causes the lungs to lose function.

As of today, a new rule is set to go into effect regarding the drug, hydroxychloroquine. The OPB published a memo on the rule change stating “in general, the rule prohibits the use of hydroxychloroquine and chloroquine for the treatment or prevention of COVID-19.”

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FDA Revokes Emergency Use of Malaria Drugs to Treat Coronavirus, Cites ‘Potential Risks’

U.S. regulators on Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause deadly side effects.

The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.”

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Commentary: Progressive Woke Orthodoxy Obscures the Truth About the Virus

Americans are acquainted with predictable but ultimately failed progressive efforts to suppress free expression by preemptive invective and politically correct finger-pointing.

To believe that U.S. Supreme Court Justice Brett Kavanaugh’s accusers revealed too many contradictions, too many lacunae, too many episodes of timely amnesia, and too many unsubstantiated accusations in their testimonies was chauvinistically to attack/smear/silence all women’s voices – at least until the same sort of memory-repressed accusations focused on handsy Joe Biden.

To express skepticism that current global temperatures are uniformly rising almost entirely due to human carbon emissions, that this state of affairs poses catastrophic dangers that may end civilization as we know it, and that this emergency can only be addressed by the radical restructuring of global economies is to be rendered a denialist, a crank, a fool.

But these parameters of censorship have a logic and predictability, given their race/class/gender/environmental orthodoxy.

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Senator Marsha Blackburn Urges FDA to Respond to Critical Drug Shortages

Senator Marsha Blackburn

U.S. Republican Sen. Marsha Blackburn of Tennessee this week urged U.S. Food and Drug Administration officials to address shortages of drugs used to treat patients with lupus.

Hydroxychloroquine and chloroquine, used to treat autoimmune diseases like lupus, are currently used to treat COVID-19.

“We should not be facing a choice between treating lupus and COVID-19,” Blackburn said in a statement.

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FDA Issues Emergency Authorization Of Anti-Malaria Drugs As Doctors Herald Results For Coronavirus Patients

The United States Food and Drug Administration issued an emergency use authorization for donated anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate as doctors say the drugs are showing positive results for coronavirus patients.

The FDA issued the authorization to allow doctors to distribute and prescribe the anti-malaria drugs to hospitalized teen and adult patients who have coronavirus, the Department of Health and Human Services said in a press release. Doctors may distribute and prescribe the drugs “as appropriate, when a clinical trial is not available or feasible.”

The emergency authorization was issued to the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority, which is working with the National Institute of Health to plan clinical trials of the drugs.

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DeWine Thanks President Trump for Approving Plan for Battelle to Sterilize Hundreds of Thousands of Protective Masks

Ohio Governor Mike DeWine and Lt. Governor Jon Husted on Sunday thanked President Trump and Dr. Stephen Hahn of the U.S. Food and Drug Administration (FDA) for approving a plan to sterilize N95 masks to fight the coronavirus.

Earlier Sunday, DeWine called an emergency press conference to express his “deep disappointment” with the FDA for limiting the use of the new technology, The Ohio Star reported.

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Mayo Clinic Says It Can Now Perform Up to 4,000 COVID-19 Tests Daily

Mayo Clinic announced last week that it can now test up to 4,000 clinical samples for SARS-CoV-2, the virus that causes COVID-19, on a daily basis.

Mayo officials said they now have the capacity to process COVID-19 test samples at all Mayo Clinic sites and have started processing test samples from their clients across the state, including eight major health systems.

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FDA Authorizes New 45 Minute Coronavirus Test for Release Next Week

A California-based molecular diagnostics company announced Saturday they will ship a point-of-care test next week that they say can detect SARS-CoV-2, the virus causing COVID-19 in 45 minutes.

Officials at the U.S. Food and Drug Administration gave that company, Cepheid, Emergency Use Authorization to do so, company officials said in a press release.

Called the Xpert Xpress SARS-CoV-2, the test is designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, with a detection time of less than one hour.

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President Trump Says FDA Has Approved Testing of Anti-Malaria Drug Chloroquine for Treating Coronavirus

President Donald Trump announced during a Thursday press briefing that the anti-malarial drug chloroquine was approved by the Food and Drug Administration as a possible treatment for the coronavirus.

The announcement comes the day after Breitbart News reported that the medical establishment has known about chloroquine’s effectiveness in treating the virus since at least the 2005 SARS coronavirus outbreak.

“Clinical trials are already underway for many new therapies and we’re working on scaling these to allow many more Americans to access different drugs that have shown really good promise,” President Trump said.

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Trump Administration Ends Contract Supplying Fetal Tissue for Research

by Rachel del Guidice   The Trump administration has ended the government’s contract with a bioscience company that provided human fetal tissue from elective abortions for testing purposes. The Food and Drug Administration no longer will obtain the fetal tissue from California-based Advanced Bioscience Resources Inc., the Department of Health and Human Services announced Wednesday. The statement announcing the change said HHS was not satisfied with the results of a review it conducted to make sure that the procurements were in keeping with government regulations and with ethical and moral concerns. “The Trump administration has rightfully taken action to separate federal research funding from the abortion industry,” Melanie Israel, a research associate at the DeVos Center for Religion and Civil Society at The Heritage Foundation, said in a written statement. At the time the review began, HHS had a contract with the University of California, San Francisco to conduct fetal tissue research and had been reauthorizing the contract with 90-day extensions. “The audit and review helped inform the policy process that led to the administration’s decision to let the contract with UCSF expire and to discontinue intramural research– research conducted within the National Institutes of Health (NIH)–involving the use of…

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Despite Growing Support for Hemp Legalization, Ohio Government Cracks down

As the Ohio Senate considers legalizing hemp and hemp byproducts in the Buckeye State, the Ohio Department of Health, along with the Food and Drug Administration (FDA), is simultaneously cracking down on any form of sale of the substance. Currently, hemp is trapped in a complicated legal limbo and while state legalization will alleviate many of the issues, the future is still opaque for the controversial drug. On February 20th, Senate Bill 57 (SB 57) was officially introduced. The bill would not simply legalize the sale of hemp and hemp related products, but also legalize: Possess, buy, or sell hemp or a hemp product; Process hemp into a hemp product, including by the addition of one or more cannabinoids derived from hemp,including cannabidiol, to a product to produce a hemp product; Conduct agricultural, academic, or any other research involving hemp or hemp products. Notwithstanding any other provision of the Revised Code to the contrary, the addition of hemp or cannabinoids derived from hemp, including cannabidiol, to any product does not adulterate that product. The specific types of products include: …any product made with hemp, including cosmetics, personal care products, dietary supplements or food intended for animal or human consumption, cloth, cordage, fiber, fuel, paint, paper, particleboard, and any product…

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FDA: More Blood Pressure Drugs May Have Shortages After Recalls

by Reuters   Additional shortages of blood pressure drugs in the United States are possible following recent recalls related to traces of a probable carcinogen found in some versions a particular class of hypertension medicines, the U.S. Food and Drug Administration said Friday. The drugs, including valsartan, belong to a class of widely-used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs. Valsartan is the generic of Novartis’ Diovan. The FDA also said it may have identified the root cause of the potentially cancer-causing impurities but that it is still investigating. The recalls began last summer after the FDA was informed that ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co (Huahai) to produce valsartan contained the impurities. The FDA later halted all imports from one of Huahai’s factories. Other manufacturers have also had to recall valsartan after the impurities were found in their versions of the drug. It is currently listed as in shortage by the FDA. Generic drugs Some generic versions of other ARBS, such as losartan and irbesartan, have also been recalled. The most recent recall was announced earlier this week. The agency said that it determined that the impurities “may be generated…

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Ohio Medical Board Tightens Rules for Opioid Prescriptions

Long overdue limits on opioid prescriptions are finally being introduced to the Buckeye State. As of Wednesday, the State Medical Board of Ohio has enacted new requirements that must be met for the prescribing and continuing use of opioids. The rules will affect both short term and long term prescriptions. How stringent the rules are depend on the current dosage. MED or “Morphine Equivalent Daily Dose” is the unit of measurement by which all opioids are measured for effectiveness. For prescriptions of up to 50 MED: prescribers are required to re-evaluate the status of the patient’s underlying condition causing pain, assess functioning, look for signs of prescription misuse, consider consultation with a specialist and obtain written informed consent from the patient. For up to 80 MED, prescribers will do all of the above and consider prescribing naloxone, a drug that functions as an incredibly effective treatment for opioid overdoses. Though it can be administered in a myriad of ways, naloxone is most commonly prescribed as a nasal spray. Lastly, for prescriptions of 120 MED and above, “there must be a recommendation from a board-certified pain medicine physician or board certified hospice and palliative care physician that is based upon a face-to-face visit…

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Senate DFL Introduces Slate of Identity Politics Bills, Seeks to Loosen Prevention of HIV in Blood Donations

The Minnesota State Senate plans to introduce 92 new pieces of legislation Monday, several of which are backed by the DFL, and focus on LGBT or race issues. Senate File (SF) 95, for instance, urges President Donald Trump and Congress to direct the Food and Drug Administration (FDA) to “revise its current blood or plasma donor deferral policy related to men who have had sex with a man and to women who have had sex with a man who has had sex with another man within the previous 12 months from the most recent contact.” The resolution, co-authored by five DFL senators, argues that the United States is “facing a critical shortage of blood donations,” which could be offset by revising an FDA donor deferral policy that “prohibits approximately 19 million American men and women from donating blood and plasma.” “Advances in HIV donor testing have reduced the risk of HIV transmission from blood transmissions to about one in 1.47 million transfusions,” the bill continues, calling for a revised policy “based on individual assessment of the risk posed by the donor.” SF 107, meanwhile, calls for the establishment of a “Council on LGBTQI Minnesotans,” which would consist of “two members…

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Dr. Carol M. Swain Commentary: Congress’s Role in Creating America’s Healthcare Crisis

by Dr. Carol M. Swain   In 2017, President-elect Donald Trump sent pharmaceutical stocks into a nosedive by speaking an important truth. Drug companies, he said, are “getting away with murder” with their pricing of lifesaving drugs. True to his word, the president, since his election, has pushed for needed reforms  aimed at lowering the costs of prescription drugs. On this matter, the president and socialist Sen. Bernie Sanders (I-VT) agree: Americans are paying too much for drugs, medical supplies, and equipment. The president and Sanders would like to see U.S. prices aligned with other nations’ lower prices. I recently attended a meeting in Washington of health care professionals, where the attendees were mostly physicians and other citizens, including pastors and health care workers, concerned about the high cost of drugs and the effect that drug shortages have on their patients and congregants. The meeting was racially and politically diverse. Of great concern was the life-threatening situations people are placed in when making decisions about whether to purchase their medicine or pay the rent or house note. As informed as I am on many issues, this was an area of ignorance for me. I had never heard of legalized drug kickbacks and relationships between hospitals, facilities,…

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Dr. Carol M. Swan Commentary: Congress’s Role in Creating America’s Healthcare Crisis

by Dr. Carol M. Swain   In 2017, President-elect Donald Trump sent pharmaceutical stocks into a nosedive by speaking an important truth. Drug companies, he said, are “getting away with murder” with their pricing of lifesaving drugs. True to his word, the president, since his election, has pushed for needed reforms  aimed at lowering the costs of prescription drugs. On this matter, the president and socialist Sen. Bernie Sanders (I-VT) agree: Americans are paying too much for drugs, medical supplies, and equipment. The president and Sanders would like to see U.S. prices aligned with other nations’ lower prices. I recently attended a meeting in Washington of health care professionals, where the attendees were mostly physicians and other citizens, including pastors and health care workers, concerned about the high cost of drugs and the effect that drug shortages have on their patients and congregants. The meeting was racially and politically diverse. Of great concern was the life-threatening situations people are placed in when making decisions about whether to purchase their medicine or pay the rent or house note. As informed as I am on many issues, this was an area of ignorance for me. I had never heard of legalized drug kickbacks and relationships between hospitals, facilities,…

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Promise Kept: President Trump’s Landmark ‘Right to Try’ Legislation Curbs Government’s Monopoly on Medicine for Terminally Ill Patients

Trump right to try

In a signing ceremony on Wednesday, President Trump fulfilled another campaign promise by signing legislation nicknamed “Right to Try” that will expand seriously ill patients’ access to experimental treatments that could extent or even save their lives. Mr. Trump called the measure a “fundamental freedom” for people with terminal conditions to use medicines that have not yet completed the approval process of the Food and Drug Administration, but nonetheless show promise in their initial testing. “With the ‘Right to Try’ Law I am signing today, patients with life-threatening illnesses will finally have access to experimental treatments that could improve or even cure their conditions,” President Trump said. The bill was passed by the House of Representatives last week largely along party lines, with Republicans backing the measure – saying it could give hope to people looking to save their own lives – while Democrats opposed the the bill, citing such a law would engender ‘false hope.’ Similar laws have been passed in all but ten states with broad support by both parties – an uncomfortable fact many Democrats will have to explain as they return home for the campaign season. As Marc Thiessen wrote in the Washington Post Wednesday, “In the states, Right to…

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Trump Is Following Through On His Pledge To Lower Drug Prices, Here’s The Plan

by Steve Birr   The Trump administration released its blueprint for lowering skyrocketing prescription drug prices Friday, a strategy that has already saved patients nearly $9 billion. President Donald Trump, along with Health and Human Services Secretary Alex Azar, outlined their four-pronged approach to making medications more affordable during an afternoon press conference. Their approach includes: expanding access to generic drugs of more expensive brand names, sweeping Medicare reforms that allow better price negotiation, removing incentives for high list prices and drastically reducing the out-of-pocket expenses of America’s seniors. “President Trump and his Administration are already delivering on the promise to lower drug prices for American patients,” Deputy Press Secretary Hogan Gidley told The Daily Caller News Foundation. “In the past year we have been very successful increasing competition and curbing high drug prices and are pleased to report that FDA’s 2017 generic drug approvals in 2017 saved prescription drug buyers in America nearly $9 billion.” The U.S. Food and Drug Administration set a record in 2017 for approving the most generic drugs in the history of the regulatory agency. A sharp increase in drug approvals coupled with new FDA guidance that helps companies complete the generic drug approval process faster led to $8.8 billion…

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President Trump Faces Institutional Obstacles to Overcome U.S. Drug Pricing Fiasco

President Trump is scheduled to deliver his first speech Friday to introduce an overarching plan to confront high drug prices. As a candidate, where he railed against the pharmaceutical industry and accused it of “getting away with murder.” The populist rhetoric appears to be giving way to a more nuanced strategy focused on making the pharmaceutical market more open and competitive, with the aim of lowering costs for consumers. It’s an approach that could avoid a direct confrontation with the powerful pharmaceutical lobby, but it could also underwhelm Americans seeking relief from escalating prescription costs. Administration officials previewing the speech Thursday touted it as the most comprehensive plan to tackle prescription drug costs that any president has ever proposed, but offered few specifics. Officials said the plan would increase competition, create incentives for drugmakers to lower initial prices and slash federal rules that make it harder for private insurers to negotiate lower prices. The result would be lower pharmacy costs for patients — a key Trump campaign promise. The plan will not include giving the federal Medicare program power to directly negotiate prices with drugmakers, they noted. Trump campaigned on the idea, which is vigorously opposed by the pharmaceutical industry. Public outrage…

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Family Farm Could Face Prison for Calling Skim Milk by Its Name

Dairy Cow

by John-Michael Seibler   Forget narcotics. Uncle Sam has a new substance to crack down on: all-natural skim milk. Food and Drug Administration regulations make it a federal crime for dairy farmers to call all-natural skim milk exactly what it is – skim milk. Instead, the FDA demands that farmers label additive-free skim milk as “imitation milk product,” because, in the FDA’s mind, skim milk just isn’t the real thing. The FDA’s finicky rules are not going unchallenged, however. Attorneys with the Institute for Justice are challenging those rules on behalf of a dairy farmer, Randy Sowers, who wants to sell all-natural products and label them honestly, without the threat of fines or imprisonment. Randy and Karen Sowers founded their South Mountain Creamery in Maryland on rented land back in 1981. They took out a loan and bought 100 cows. Today, three generations of Sowers work on their family’s 2,200 acre farm. They have more than 600 cattle, plus 16,000 chickens. Their family employs more than 75 people. The liberal Left continue to push their radical agenda against American values. The good news is there is a solution.  Find out more >> They also believe in keeping their products additive-free. Naturally, they would like to…

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Commentary: The Deadly Incompetence of the FDA

by Dan Mitchell   I routinely grouse about the heavy economic cost of red tape. I’ve also highlighted agencies (such as the EEOC) that seem especially prone to senseless regulations. And I’ve explained why private regulation actually is a very effective way of promoting health and safety. Today, let’s get specific and look at the Food and Drug Administration. This bureaucracy ostensibly is supposed to protect us by making sure drugs and medical devices are safe and effective before getting approval, which seems like it might be a reasonable role for government. But the FDA routinely does really foolish things that undermine public health. The likely reason is that the bureaucracy has a bad incentive structure. As Professor Alex Tabarrok has explained. …the FDA has an incentive to delay the introduction of new drugs because approving a bad drug (Type I error) has more severe consequences for the FDA than does failing to approve a good drug (Type II error). In the former case at least some victims are identifiable and the New York Times writes stories about them and how they died because the FDA failed. In the latter case, when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible…

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How Government Makes Us Fatter and Fatter

by Jenna Robinson   The government, with its accomplices in the food lobby, has helped to make and keep us fat. Through subsidies and misguided food suggestions, Congress, the FDA, and the USDA have made it more difficult for Americans to make smarter dietary decisions. It’s not as if we don’t care. Americans spend $33 billion annually on weight-loss products and services. At any given time, 45 percent of women and 30 percent of men in the United States are trying to lose weight. And yet Americans are more out of shape than ever. Obesity is a major health risk in the United States, where 65 percent of adults are overweight. The prevalence of obesity rose from 14.5 percent in 1980 to 30.5 percent today. The percentage of children who are overweight is at an all-time high: 10.4 percent of two- to five-year-olds, 15.3 percent of six- to 11-year-olds, and 15.5 percent of 12- to 19-year-olds. Misinformation Remember the food pyramid? In 1982, government authorities told Americans to reduce fat consumption from 40 percent to 30 percent of daily intake—and we took their advice. Instead of fats, Americans began eating more carbohydrates: an increase of 57 grams per person from…

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Beth Harwell, Now Having A Family Member Using It, Is Open To And Looking At Medical Marijuana

  Gubernatorial candidate and Tennessee House Speaker Beth Harwell (R-Nashville) said at a gathering earlier in the month that after her sister sustained an injury, she has personal interest in the issue of medical marijuana. Regarding the task force she formed earlier in the year on the issue, she said, “We’re open to that, we’re looking at that.” According to an Associated Press report picked up by Connecticut-based The New Haven Register, Harwell relayed her personal story of how her sister broke her back and was prescribed opioids for the pain. The injury to her sister is the reason Harwell cited in a letter to the Rutherford County Republican Party explaining why she was unable to attend the Reagan Day dinner in May. Harwell recalled to the group that her sister, who had been prescribed opioids for her pain, “had no doubt” in her mind that if she were to “continue this opioid regimen, I will become addicted to opioids.” With Harwell’s sister living in Colorado where marijuana has been legalized, she used some for four or five days until she felt better after the initial doses of opioids, which she wanted to stop taking. The opioid crisis in Tennessee…

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