Tag: FDA

Biden Announces Former Obama FDA Commissioner Robert Califf to Lead FDA Again

Virginia Star Staff
Robert Califf

President Joe Biden on Friday announced the nomination of Robert Califf to head up the Food and Drug Administration again, urging the Senate to quickly confirm him a second time.

Califf, who served in the same role near the end of then-President Barack Obama’s second term, is “one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement announcing the pick.

“I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making,” the president added, pointing out that Califf enjoyed “strong bipartisan support in the Senate in 2016.”

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Commentary: Defense Department Pulls a Bait and Switch on Vaccines

Virginia Star Staff

On August 24, Secretary of Defense Lloyd Austin issued a memo to senior Pentagon leadership announcing that he was implementing a mandatory COVID-19 vaccination policy for all military service members. The day before, the FDA had issued full authorization to Pfizer for their Comirnaty COVID-19 vaccine product (the nomenclature of which is meant to be a mashup of the words “COVID”, “mRNA”, and “community”) . At first glance it would seem that the mandatory vaccination policy, while scientifically unsound and strategically foolish, was at least a policy being implemented according to both the letter of the directive and in accordance with the law. But a further examination of the facts and the manner in which this order is being implemented makes clear that the military’s implementation of this order is illegal and highly unethical.

In the memo, Secretary Austin issued a directive and a promise, that “Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.” The problem with this is that the Comirnaty vaccine product that was approved by the FDA is not available anywhere in the Military Health System. It is not even in production, according to the military’s TRICARE healthcare providers. If a soldier goes to a military hospital or a private provider to receive an approved Pfizer COVID vaccine, he will be administered the unapproved Pfizer-BioNTech vaccine which is a vaccine that is not approved but has been administered under an Emergency Use Authorization (EUA). We are told that this is but a brand name difference, that the formulation is the same, and they can be used interchangeably. But as the FDA was approving the Comirnaty product, they were renewing the authorization for the Pfizer-BioNTech product. If it’s just a matter of brand name, why issue an approval for one brand name and an EUA renewal for the other? This is because they are not actually the same. 

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Commentary: The FDA’s Power over Food and Drug Approval

Virginia Star Staff

Competition tends to bring about a better product or service, at a lower price, than does monopoly. This is a basic premise held by virtually all economists, disputed by pretty much no one in the profession. The entire antitrust edifice of the American system is built upon this foundational aspect of the dismal science.

And yet when push comes to shove, our society jettisons this insight, at least when it comes to assuring the quality of our food and drugs.

The Food and Drug Administration is a monopoly agency entrusted with this task. Its word is final concerning such matters. No competition is allowed. If a private agency set itself up as an alternative, it would first be subjected to raucous laughter, and then its creators jailed.

The FDA is a licensing agency. If it does not approve of a food or drug, it is illegal to offer it for sale. What is the non-monopolistic alternative to this sad state of affairs? This is called certification. How, pray tell, does this work? It is simple. Different firms set themselves up as evaluators of the quality of food and drugs, and each of them subjects these products to their examinations. They certify some as approved, and list others as not approved.

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Lawmakers Seek Federal Grand Jury Investigation for COVID-19 Statistical Manipulation

Virginia Star Staff

The CDC adopted a “double-standard exclusively for COVID-19 data collection” that inflated cases and deaths starting early in the pandemic, violating multiple federal laws and distorting mitigation policies, Oregon lawmakers told the feds’ top lawyer in the state.

Advised by “a large team of world-renowned doctors, epidemiologists, virologists, and attorneys,” state Senators Kim Thatcher and Dennis Linthicum petitioned U.S. Attorney Scott Asphaug to approve a grand jury investigation into how the pandemic is being measured.

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Commentary: New Ways to Diagnose Alzheimer’s Are Here, and Better Ones Are on the Way

RealClearWire

In sharp contrast to every other top-ten cause of death, Alzheimer’s disease has long lacked affordable and accessible ways to diagnose it. While doctors have been able to tell patients with almost 100% certainty whether they have diabetes, heart disease or cancer, until recently, Alzheimer’s was a diagnosis of exclusion.

Doctors could look for signs of Alzheimer’s. They could test memory and other cognitive skills, judge a patient’s ability to perform routine tasks, and ask their friends and family about any behavior changes. MRIs could determine brain volume, which diminishes as Alzheimer’s progresses. But blood and other diagnostic tests were used only to rule out other possible causes of their symptoms, such as B12 deficiency or thyroid disorders.

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FDA Says It Does Not Buy Fetal Tissue – Any More

Virginia Star Staff
Baby covered in a blanket

The Food and Drug Administration assured the Daily Caller News Foundation Friday that it has not entered into any contracts “for the purchase of human fetal tissue” since 2018.

The agency’s response follows the release of documentation obtained by Judicial Watch showing that the FDA procured fetal organs, tissue, and heads for research that involved “humanized mice.” Previous documents uncovered by Judicial Watch found that the FDA requested “fresh and never frozen” fetal organs.

“I’ve been doing this for 23 years. These documents we’ve gotten from the FDA and our other lawsuit…they are the worst things I’ve ever seen,” Judicial Watch President Tom Fitton told the Daily Caller News Foundation Friday. “The most troubling documents I’ve ever seen.”

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Former FDA Head Says CDC Guidance Hurt Pandemic Response

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Scott Gottlieb

The Centers for Disease Control and Prevention’s guidance ultimately hindered the U.S. response to the pandemic, former FDA Commissioner Scott Gottlieb wrote in his upcoming book “Uncontrolled Spread,” set to be released Sept. 21.

Gottlieb said in the book that U.S. intelligence agencies need to play a more active role in preparing for a pandemic, as opposed to leaving plans solely to health agencies like the CDC.

“We need to have human assets in the medical community so we understand when an outbreak emerges,” Gottlieb said, Axios reported. “We need to have the capability of monitoring typical streams of intelligence, like signals intelligence and maybe even satellite intelligence, looking for things that could be trip wires for an outbreak of disease.”

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Report: Top Health Officials Tell White House to Pause Vaccine Booster Plan

Virginia Star Staff

Top U.S. health officials told the White House pandemic coordinator on Thursday to scale back the Biden administration’s plan to administer the coronavirus booster shots to individuals in September, The New York Times reported.

Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration (FDA), and Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention (CDC), told White House Coronavirus Response Coordinator Jeffrey D. Zients that they need more time to collect and analyze the necessary data relating to the booster shots, The New York Times reported.

The doctors told Zients that their agencies might be able to determine whether to recommend boosters for recipients of the Pfizer-BioNTech vaccine in the coming weeks, according to the Times.

The two doctors presented their argument to Zients at a meeting on Thursday. It is unclear how Zients responded to the news.

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Commentary: The Clear Case for Joe Biden’s Impeachment

Virginia Star Staff

Alan Dershowitz says calls for the impeachment of Joe Biden are “wrong.” He claims in his most recent op-ed at the D.C. establishment’s favorite Republican rag, The Hill: “Whatever one may think of what Biden did or failed to do, it does not constitute an impeachable offense under the text of the Constitution.” With all due respect, Dershowitz is full of crap.

“The Framers,” Dershowitz writes, “insisted that a president could not be impeached unless he committed criminal-type conduct akin to treason and bribery.” If this is true, then why did President Thomas Jefferson call for the impeachment of a federal district judge on the grounds that he was “a man of loose morals and intemperate habits?” Jefferson was a prominent founder, who greatly influenced the framers of the Constitution.

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‘Require It’: Biden Tells Private Companies to Mandate COVID-19 Vaccinations

Virginia Star Staff
Man getting COVID vaccine

President Joe Biden encouraged private sector companies Monday to “step up” vaccine requirements for employees following the Food and Drug Administration’s approval of the Pfizer COVID-19 vaccine.

“If you’re a business leader, a non-profit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that. Require it,” Biden said. “Do what I did last month. Require your employees to get vaccinated or face strict requirements.”

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Lawyer Suing Indiana University for COVID Vaccine Mandate Expanding Effort to ‘Four or Five States’

Virginia Star Staff

The lawyer representing students challenging Indiana University’s COVID vaccine mandate has been “retained by students in other states to bring similar claims,” he said in an interview Tuesday.

Veteran litigator James Bopp told the John Solomon Reports podcast that he expects to file suit in another “four or five states in the next couple of weeks.”

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United Airlines to Become First Major Airline Requiring Staff be Vaccinated

Virginia Star Staff
United Airlines plane on runway

United Airlines announced Friday that it will require all employees to be vaccinated against COVID-19 starting this fall, making it the first major airline to do so.

“We know some of you will disagree with this decision to require the vaccine for all United employees,” United CEO Scott Kirby and President Brett Hart announced in a memo. “But, we have no greater responsibility to you and your colleagues than to ensure your safety when you’re at work, and the facts are crystal clear: everyone is safer when everyone is vaccinated.”

The order requiring proof of vaccination will go into effect five weeks after the Federal Drug Administration officially gives full approval of the COVID-19 vaccines, or by Oct. 25, whichever comes first, The Hill newspaper reports. The FDA is expects to start giving full approval as early as next month.

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FDA Asks for Internal Review of Approval Process for Alzheimer’s Drug

Virginia Star Staff

The U.S. Food and Drug Administration is asking for an internal review of its own approval process that gave a greenlight to a drug to treat Alzhiemer’s, a move that could shed more light on the controversial chain of decision-making that led to the drug’s being okayed for use.

The FDA last month approved drug company BioGen’s product Aduhelm, the first medicine greenlit in the U.S. to slow the cognitive decline of those living with Alzhiemer’s.

Yet that decision was shrouded in controversy: The approval went against the advice of an outside panel of FDA experts and even led to the resignation of several of those experts in protest.

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Fully Vaccinated Do Not Need Booster for Delta Variant, CDC and FDA Say

Virginia Star Staff

Fully vaccinated Americans do not need to receive a booster shot to protect against the Delta variant, the Centers for Disease Control and Prevention and Food and Drug Administration said in a press release.

“People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta,” a joint statement said on Thursday.

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U.S. Government Allocates $3.2 Billion for COVID-19 Antiviral Pills

Virginia Star Staff
Department of Health & Human Services

The Department of Health and Human Services will invest $3.2 billion to develop and manufacture COVID-19 antiviral medicines, it announced Thursday.

The initiative, funded as part of the American Rescue Plan, is designed to accelerate research into antivirals as well as build platforms for urgent response to future viral threats, the Department of Health and Human Services (HHS) said in a statement Thursday. Specifically, the plan expands antiviral clinical trials, forms partnerships between health agencies and pharmaceutical companies, and funds “drug discovery groups” tasked with innovating new antiviral medicines.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said chief medical adviser Dr. Anthony Fauci in the statement.

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Study Finds Novavax COVID-19 Vaccine 90 Percent Effective

Virginia Star Staff
Doctor preparing COVID-19 Vaccine

Novavax announced on Monday that its two-dose COVID-19 vaccine is 90% effective, according to a press release on Novavax’s website.

The phase-3 trial enrolled 29,960 participants ages 18 and older in the U.S. and Mexico. The study found that 77 of the participants tested positive for COVID-19, with 63 testing positive in the placebo group and 14 in the vaccine group, according to the press release.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” Stanley C. Erck, President, and CEO of Novavax said in the press release.

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Pro-Life Groups Accuse FDA of ‘Ignoring the Science’ on at-Home Abortion Drugs

Virginia Star Staff

Pro-life groups are accusing the Food and Drug Administration of “ignoring the science” by removing restrictions that prevented abortion drugs from being delivered by mail.

The national pro-life Susan B. Anthony List (SBA List) and its research and education arm, the Charlotte Lozier Institute (CLI), said Tuesday that the FDA’s decision to remove restrictions on abortion drugs “ignores the risk of increased mortality and morbidity for women taking the abortion pill,” according to an SBA List press release.

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Arizona House Passes Bill Banning Abortions Based on Genetic Abnormality

Virginia Star Staff
Susan B. Anthony List State Policy Director Sue Liebel

The Arizona House passed a bill Thursday that bans abortions based on diagnosis of genetic abnormality, such as Down syndrome.

S.B. 1457 states that the rights of “an unborn child at every stage of development” must be acknowledged and prohibits abortions based on the sex, race, or genetic abnormality of the child. The bill makes exceptions for medical emergencies.

“A person who knowingly” performs such an abortion “is guilty of a class 3 felony,” according to the legislation.

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Factory Mixup Ruins 15 Million Johnson & Johnson Coronavirus Vaccines

Virginia Star Staff
COVID-19 Vaccinations

Workers at a Baltimore plant responsible for producing two separate coronavirus vaccines mistakenly mixed up their respective ingredients, ruining approximately 15 million doses of Johnson & Johnson’s vaccine and pausing all production at the plant, the company confirmed Wednesday.

The facility, run by Emergent BioSolutions, had partnered with both Johnson & Johnson and AstraZeneca to produce vaccines. Federal officials said that the mistake was a result of human error, according to The New York Times, which first reported the mix up that reportedly occurred several weeks ago.

A quality control review “identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine,” Johnson & Johnson said in a statement. “This batch was never advanced to the filling and finishing stages of our manufacturing process.”

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FDA Panel Votes to Recommend Johnson & Johnson’s Coronavirus Vaccine for Emergency Authorization

Virginia Star Staff

The Food and Drug Administration’s vaccine advisory panel voted Friday evening to recommend Johnson & Johnson’s coronavirus vaccine for emergency approval, clearing the way for its authorization, distribution and administration nationwide.

The vote followed hours of the panel live-streaming its process of scouring over data from the pharmaceutical company in order to reaffirm that the vaccine was safe for the millions of Americans who will receive it. The FDA also released the vaccine’s clinical trial data on Wednesday showing that the vaccine was effective in fighting the virus itself.

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Coronavirus Vaccines Can Guard Against New, More Contagious UK Strain, Experts Say

Virginia Star Staff

The two coronavirus vaccines that have been approved for emergency use authorization in the U.S. will be able to combat a new, more contagious strain of the virus in the U.K., experts said Monday.

Vaccines made by pharmaceutical companies Pfizer and Moderna will be effective against the new strain, which is “very similar” to previous strains at the genetic level, University of Washington’s Institute for Health Metrics and Evaluation affiliate assistant professor Vin Gupta told CNBC. The Food and Drug Administration has approved both vaccines for emergency use authorization after large-scale human trials showed efficacy of more than 90%.

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FDA Grants Moderna’s Coronavirus Vaccine Emergency Authorization

Virginia Star Staff

The FDA approved Moderna’s coronavirus vaccine for emergency use Friday, making the United States the first country to have approved two safe and effective vaccines against COVID-19.

Its approval follows a key FDA panel’s overwhelming vote Thursday to endorse the vaccine’s safety and efficacy. The Moderna vaccine’s approval means that its distribution could begin within hours, providing hospitals and long-term care facilities across the country thousands of much-needed doses.

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FDA Authorizes First Over-the-Counter Home Coronavirus Test

Virginia Star Staff

The Food and Drug Administration approved the first over-the-counter, at-home coronavirus test Tuesday.

The test, developed by the Australian company Ellume Limited, is a rapid antigen test that can deliver results in approximately 20 minutes, and works on any patient older than two years of age, the FDA said in its announcement.

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FDA Review Reaffirms Moderna Coronavirus Vaccine’s Safety, Efficacy

Virginia Star Staff

The FDA released data Tuesday reaffirming that Moderna’s coronavirus vaccine is safe and effective in preventing severe cases in adults.

The release is a sign that the vaccine is likely to be granted emergency use from the FDA in the coming days, public health officials said, a critical step in ensuring that millions of Americans can be vaccinated as soon as possible. The FDA released similar data regarding Pfizer’s vaccine just days before it was given emergency approval as well.

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

Virginia Star Staff

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

Virginia Star Staff

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

Virginia Star Staff

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

The Associated Press

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

Virginia Star Staff

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 Associated Press

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

Virginia Star Staff

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

The Associated Press

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

The Associated Press

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

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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…

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

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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…

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