Tag: FDA

US House Passes Abortion Defense Bill in Response to End of Roe Protections

Ilya Tsukanov – July 15, 2022

Democratic Party lawmakers in both houses of Congress have vowed action to protect women’s ability to travel across state lines to get an abortion after Republican states rushed to criminalize the procedure. The legislative rush has come in the wake of the Supreme Court’s decision to abolish federal abortion protections last month.

The House of Representatives passed two bills Friday aimed at safeguarding abortion access, including a measure allowing women to travel across state lines to get the procedure if it is banned in their home state.

The first bill, entitled the ‘Ensuring Access to Abortion Act’, was passed by a margin of 223-205, with three Republicans, including never Trumper Adam Kinzinger of Illinois, joining all 220 Democrats to vote in favor of the measure.

The bill proposes making it illegal for states where abortion is lawful to bar women from out of state from getting the procedure at a registered clinic, introduces legal protections for those who assist women getting an abortion, and provides for the legalization of the interstate transportation of Food and Drug Administration-approved abortion drugs.

The second bill, the ‘Women’s Health Protection Act’, was passed 219-201, with Democratic Congressman Henry Cuellar of Texas the only Democrat to vote against. That bill has already been around the block of congressional debate, and was passed by the House last September, but thrown out twice by the Senate, which is split 50/50 between Republicans and Democrats.

Senate Democrats drafted legislation similar to the ‘Ensuring Access to Abortion Act’ earlier this week, calling it the ‘Freedom to Travel for Health Care Act of 2022′. That bill proposes protections for non-profits which assist women traveling to states where abortion is permitted to get the procedure.

The fate of both of the House bills passed Friday remains uncertain amid the possibility that rogue Democrat Senators Joe Manchin and Kyrsten Sinema could block their Senate versions. The two lawmakers already dashed Democrats’ hopes for a filibuster change to codify federal abortion rights late last month, despite paying lip service of their support for Roe v Wade.

Lawmakers also face time constraints, with the House going on a month-long recess at the end of July, and the Senate following suit a week later in early August.

https://sputniknews.com

Troops accuse Pentagon of ‘religious purge’

RT – April 29, 2022

The US government is still mandating all members of the military to get a Covid-19 vaccine and discharging those who refuse – even on religious grounds – in what amounts to a deliberate purge of troops with beliefs the current Pentagon considers wrong, a sergeant and two officers told the podcast hosted by Republican congressman Matt Gaetz on Thursday.

Gaetz (R-Florida), who hosts a podcast called ‘Firebrand,’ said he wants to propose an amendment that would ban mandates for experimental vaccines and restore rank and pay to those forced to leave the military, but admitted that some of his Republican colleagues might not support it, not to mention the majority Democrats.

“If you are a believer and you are listening to this podcast, you need to understand that God-fearing service members are being intentionally purged from the services,” said one of his guests, Air Force Captain Jordan Karr.

“It’s a purposeful purge,” argued Army Major Samuel Sigoloff. “Anyone who would disobey an unlawful order is being purged out of the military,” he added, alleging there is a “shadow policy” in place to protect the leadership doing this.

Karr, Sigoloff and Air Force Master Sergeant Nickolas Krupper made their case against the mandate by bringing up religious freedom, natural immunity, and the discrepancy between the jabs used under emergency authorization and the one officially approved, which technically isn’t available in the US.

Though they are legally distinct, the Food and Drug Administration (FDA) guidance says that Pfizer’s emergency-use vaccine and the officially approved Comirnaty “can be used interchangeably… without presenting any safety or effectiveness concerns.”

All three service members face “involuntary separation” over their refusal to get the jab, but have sued the Defense Department on religious exemption grounds. They technically remain on active duty until the lawsuits are resolved. Sergeant Krupper pointed out he is two years away from retirement and would lose his pension and family medical benefits if the USAF kicks him out.

https://www.rt.com

Elon Musk nears human testing of brain chip

RT – January 21, 2022

Neuralink, the US neurotechnology firm co-founded by billionaire entrepreneur Elon Musk, has begun recruiting key employees to run its clinical trials, signaling that it’s inching closer to starting human testing of its brain implants.

The company has posted advertisements to hire a clinical trial director and a clinical trial coordinator. The ads note that the staffers will “work closely with some of the most innovative doctors and top engineers, as well as working with Neuralink’s first clinical trial participants.” Neuralink said the director will lead and help build its clinical research team and will develop “regulatory interactions that come with a fast-paced and ever-evolving environment.” 

Musk, who ranks as the world’s richest person with a fortune estimated at $256 billion, said last month that he expects to have Neuralink brain chips implanted in humans sometime in 2022, pending approval for testing plans by the US Food and Drug Administration (FDA).

Musk and his Neuralink partners founded the company in 2016 to develop brain chips that connect humans with computers. He has claimed that the implants will enable paralyzed people to control such devices as smartphones with their brains. He expects more progress to be made, including solutions for many physical disabilities by bridging signals between neurons, once human testing begins.

Neuralink has already tested its chips in the brains of a macaque monkey and a pig. The company raised eyebrows last April, when it posted footage purporting to show a monkey playing a video game with its mind.

The first human test subjects will be people with severe spinal injuries, such as quadriplegics, Musk said last month at the Wall Street Journal CEO Council summit. “We have a chance with Neuralink to restore full-body functionality to someone who has a spinal cord injury,” he said.

https://www.rt.com

US surgeons successfully implant pig heart in human: statement

Insider Paper – January 10, 2022

US surgeons have successfully implanted a heart from a genetically modified pig in a human patient, a first of its kind procedure, the University of Maryland Medical School said Monday.

The surgery took place Friday, and demonstrates for the first time that an animal heart can survive in a human without immediate rejection, the medical school said in a statement.

The patient, David Bennett, had been deemed ineligible for human transplant.

The 57-year-old Maryland resident is being carefully monitored to determine how the new organ performs.

“It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice,” he said a day before the surgery.

Bennett, who has spent the last several months bedridden on a life support machine, added: “I look forward to getting out of bed after I recover.”

The Food and Drug Administration granted emergency authorization for the surgery on New Year’s Eve, as a last ditch effort for a patient who was unsuitable for conventional transplant.

“This was a breakthrough surgery and brings us one step closer to solving the organ shortage crisis,” said Bartley Griffith, who surgically transplanted the pig heart.

https://insiderpaper.com

Republican-Led States Restrict Telehealth Abortion Pill Distribution

Charlie McCarthy -December 23, 2021

Most red states will limit access to abortion pills despite federal regulators’ move to lift restrictions permanently on prescribing the drugs, the Washington Examiner reported.

The Biden administration, saying it wanted to reduce risks of exposure to COVID-19, temporarily suspended the in-person dispensing requirement for the two-pill medication regimen earlier this year. The agency later said it will permanently drop the rule.

Several Republican-led states have laws to limit access to the drug and supersede the updated Food and Drug Administration guidance, the Examiner reported Thursday.

Arizona, Arkansas, Missouri, and West Virginia, as well as Democrat-led Louisiana, are states that have explicitly banned telehealth visits to prescribe abortion medication. There also are other restrictions, such as waiting periods or not by mail, on dispensing the drug.

Gov. John Bel Edwards, D-La., approved a mandate last summer that had abortion providers advise patients of a possible abortion reversal “if after taking the first pill you regret your decision,” the Examiner reported.

Fifteen other states have mandated that a physician be present when the patient obtains the medication and during the procedure, effectively banning the use of telemedicine to prescribe and dispense the drug, the Examiner said.

Those states include Alabama, Indiana, Kansas, Kentucky, Mississippi, Nebraska, North Carolina, North Dakota, Oklahoma, South Dakota, South Carolina, Tennessee, Texas, and Wisconsin.

https://www.newsmax.com

FDA Will No Longer Require In-Person Doctor Visits for Abortion Pill

– December 16, 2021

The FDA announced Thursday it will no longer require in-person doctor visits for women who want the chemical abortion pill, a move some physicians say will endanger women across the country.

The agency temporarily lifted the requirement in April so doctors could prescribe the pill after a virtual visit. Unlike morning-after pills, which are available over the counter and aim to block fertilization, chemical abortion pills terminate a developing fetus in the uterus. Chemical abortion pills have four times the complication rate as surgical abortions and are more likely to send women to the emergency room. Physicians recommend in-person exams prior to prescribing abortion pills because ultrasounds can help minimize harm to the mother.

“If you can’t tell a woman how far along she is you also can’t tell her what her risks are,” Dr. Donna Harrison, the chief executive officer of the American Association of Pro-Life Obstetricians and Gynecologists, told the Washington Free Beacon. Women often misdate their pregnancies and taking the abortion pill too late could prove deadly. Harrison also noted that virtual visits would make it easier for men to force women to take the abortion pill.

“There is no way to know what abusers, what pimps, what disgruntled boyfriends will do with this drug,” Harrison told the Free Beacon. “It’s bad for women.”

Pro-choice activists are pushing to expand access to chemical abortions as states pass laws restricting surgical abortions. Plan C, a website that details how to illegally purchase chemical abortion pills online, said it has seen a significant increase in web traffic, especially in Texas, which enacted a six-week abortion ban in September. States have placed restrictions on chemical abortion pills such as requiring they be purchased in-person and through a provider, but pills not approved by the FDA have continued to sell online with ease. The FDA sent a cease and desist letter in 2019 to the top illegal supplier in the country, Aid Access, but no action has been taken to stop its sales.

The FDA announced in April 2021 that doctors could prescribe chemical abortion pills with virtual visits for the duration of the pandemic, but did not specify when that rule would lapse.

https://freebeacon.com

Elon Musk Says Neuralink Looking to Implant Brain Chips in Humans Next Year

Theodore Bunker – December 7, 2021

Elon Musk’s brain-interface technology company Neuralink hopes to implant their chips in humans with several spinal cord injuries at some point next year, if they receive approval from the Food and Drug Administration.

“Neuralink’s working well in monkeys and we’re actually doing just a lot of testing and just confirming that it’s very safe and reliable and the Neuralink device can be removed safely,” Musk said during The Wall Street Journal CEO Council Summit in an interview on Monday, when asked what the company is planning for 2022.

“We hope to have this in our first humans — which will be people that have severe spinal cord injuries like tetraplegics, quadriplegics — next year, pending FDA approval,” he said.

Musk went on to say that the company’s “standards for implanting the device are substantially higher than what the FDA requires.”

He later added on Twitter that “Progress will accelerate when we have devices in humans (hard to have nuanced conversations with monkeys) next year.”

https://www.newsmax.com

Pfizer Asks FDA to Allow COVID Shots for Kids Ages 5 to 11

Newsmax – October 8, 2021

Pfizer asked the U.S. government Thursday to allow use of its COVID-19 vaccine in children ages 5 to 11 — and if regulators agree, shots could begin within a matter of weeks.

Many parents and pediatricians are clamoring for protection for children younger than 12, today’s age cutoff for the vaccine made by Pfizer and its German partner BioNTech. Not only can youngsters sometimes get seriously ill, but keeping them in school can be a challenge with the coronavirus still raging in poorly vaccinated communities.

Pfizer announced in a tweet that it had formally filed its application with the Food and Drug Administration.

Now the FDA will have to decide if there’s enough evidence that the shots are safe and will work for younger children like they do for teens and adults. An independent expert panel will publicly debate the evidence on Oct. 26.

One big change: Pfizer says its research shows the younger kids should get a third of the dose now given to everyone else. After their second dose, the 5- to 11-year-olds developed virus-fighting antibody levels just as strong as teens and young adults get from regular-strength shots.

https://www.newsmax.com

FDA purchased baby heads and other body parts, documents show

WND Staff – September 14, 2021

Hundreds of pages of U.S. Food and Drug Administration records obtained under a Freedom of Information Act case brought by government watchdog Judicial Watch reveal the U.S. government was buying the heads of unborn babies, and other body parts, for its “humanized mice” project.

The watchdog organization announced this week it has obtained 198 pages of records from the FDA confirming the purchase plans for “human fetal heads, organs and tissue.”

The “supplies” came from Advanced Bioscience Resources, and many of the deals were reached between Perrin Lawton, of ABR, and Kristina Howard, an officer with the FDA.

The lawsuit over the records had sought “all contracts and related documentation on disbursement of funds, procedural documents and communications between FDA and ABR for the provision of human fetal tissue to be used in humanized mice research.”

A federal court recently ordered the government to provide more details about the purchase of the human body parts, “including ‘line item prices,’ or the price per organ the government paid to ABR,” Judicial Watch said.”

The court also found ‘there is reason to question’ whether the transactions violate federal law barring the sale of fetal organs. Documents previously uncovered in this lawsuit show that the federal government demanded the purchased fetal organs be ‘fresh and never frozen,'” Judicial Watch reported.

https://www.wnd.com

FDA Lifts Restriction on Remote Prescriptions of Abortion Drugs

– April 13, 2021

The Biden administration cited the coronavirus pandemic to give the green light to at-home, self-administered abortions on Monday.

The FDA said it will allow the prescription of an abortion pill, mifepristone, through the mail, reversing Trump administration restrictions on remote prescription of abortion drugs. The agency wrote that because “the in-person dispensing of mifepristone for medical termination of early pregnancy may present additional COVID-related risks to patients and healthcare personnel because it may involve a clinic visit solely for this purpose,” it will allow doctors and nurses to prescribe the medication remotely.

The letter, sent on Monday to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, states that the agency will exercise “enforcement discretion” in allowing abortion medication to be prescribed without requiring an in-person doctor’s visit.

Republican lawmakers warned against removing the requirement that the abortion medication be prescribed in person. Sen. Ben Sasse (R., Neb.) accused the Biden administration of exploiting the pandemic to advance the interests of the abortion industry.

“This move by the FDA is just using COVID-19 as a cover to dispense abortion-inducing medication remotely,” Sasse said. “We are over a year into this pandemic with health care largely returning to safe, in-person delivery. This isn’t about pandemic caution—it’s a political move to increase abortions.”

https://freebeacon.com