• Leqembi is the first new Alzheimer's treatment fully approved by the FDA in 20 years, and the first drug that slows progression of the cognitive disease.

• The FDA granted "accelerated approval" for Leqembi in January 2023, roughly three months after Biden attempted to converse with a dead congresswoman at a White House nutrition conference.

• The FDA is a federal agency housed within the Department of Health and Human Services, which is run by a presidential appointee. The timing of the drug's approval raises some troubling questions about government collusion and election interference.

SILVER ALERT: Biden's Bumbles Hit New Low

Why it matters: This is great news for Biden's reelection campaign. Leqembi has been shown to "modestly slow the pace of cognitive decline" in Alzheimer's patients, according to the New York Times.

• A modest reduction may well suffice. Biden, 80, just needs to remain minimally upright and competent until Election Day on Nov. 5, 2024.

• In phase 3 clinical trials, patients taking Leqembi experienced a 27 percent slower rate of decline compared with the placebo group.

• Side effects include brain swelling, seizures, and death.

Crucial context: Biden reportedly has been prone to violent temper tantrums since taking office, which is a common symptom of Alzheimer's and other forms of cognitive decline.

• Biden's cognitive decline was likely exacerbated by his failure to properly treat his longstanding sleep apnea, the Washington Free Beacon reported in June.

Bottom line: Biden should be resting comfortably at home, surrounded by friends and family. Not running for reelection.

The post COLLUSION? FDA Approves New Alzheimer's Drug Just in Time for Biden Reelection Campaign appeared first on Washington Free Beacon.

The Food and Drug Administration has authorized just 23 tobacco-flavored e-cigarette products for lawful sale in the United States. But the actual number of vaping devices available for purchase in the country has nearly tripled to over 9,000 since 2020, according to sales data obtained by the Associated Press. Almost all of the illegal devices are coming from China.

Illegal Chinese vapes are often marketed to teenagers with fruity flavors, and contain much more nicotine than American-made e-cigarettes. FDA commissioner Robert Califf testified before Congress in March that he’s grown increasingly concerned illicit Chinese vapes could be laced with fentanyl. The FDA claimed in May it was in the midst of a "retailer inspection blitz" to crack down on the sale of Chinese vapes, but experts say the industry knows the agency is incapable of enforcing the law.

"The FDA moves at a ponderous pace and the industry knows that and exploits it," Dr. Robert Jackler of Stanford University told the Associated Press. "Time and again, the vaping industry has innovated around efforts to remove its youth-appealing products from the market."

A convenience store located just 250 yards away from the FDA’s headquarters in Silver Spring, Md., still sells illicit Chinese vapes amid the agency’s supposed crackdown. The store sold an outlawed strawberry banana-flavored Elfbar BC5000 to a Washington Free Beacon reporter on June 15, just weeks after the FDA claimed it inspected the store and observed no tobacco-related violations.

The Elfbar purchased by the Free Beacon contained a disclosure stating the product was manufactured in China specifically for sale in the United States. Ironically, that same product cannot be purchased in China. Chinese authorities in October outlawed the sale of all flavored e-cigarettes, though they still allow such products to be manufactured and exported to other countries.

Following the Free Beacon report, the FDA issued a press release saying it issued warning letters to 189 retailers warning them to stop selling Elfbars. The convenience store next door to the FDA was notably absent from the list.

"The fact that illegal, disposable, Chinese vapes in kid-friendly flavors are being sold in the FDA's own backyard is nothing short of egregious," said Jim Carroll, the director of the Office of National Drug Control Policy under former president Donald Trump. "The FDA and Biden administration cannot waste any more time—they must make this a top priority and get illegal Chinese disposable vape products off of store shelves."

The post Number of Illegal Chinese Vapes Sold in United States Has Skyrocketed Under Biden appeared first on Washington Free Beacon.

The FDA announced just a few weeks ago, on May 31, that it was in the midst of a "retailer inspection blitz" to crack down on the sale of outlawed disposable e-cigarettes such as the Elfbar, a flavored vape manufactured in China by a subsidiary of Shenzhen IMiracle Technology. The agency claims that on May 24 it inspected the White Oak Convenience Store, which is located just 250 yards away from the FDA's headquarters in Silver Spring, Md., and observed no violations, including but not limited to selling outlawed Chinese vapes.

But the same convenience store on Thursday sold an outlawed strawberry banana-flavored Elfbar BC5000 to a Washington Free Beacon reporter, raising serious questions about the FDA's "enforcement strategy" for the illicit Chinese products.

"This clearly shows evidence that the FDA does not have an enforcement strategy," said Rich Marianos, a former assistant director of the Bureau of Alcohol, Tobacco, Firearms, and Explosives. "Even in their own backyard, they are asleep at the wheel."

The sale of illegal Chinese vapes within walking distance of the FDA's headquarters comes as the agency has moved aggressively to outlaw the sale of American-made vapes such as Juul. Elfbars and other Chinese-manufactured vapes are often packed with more potent doses of nicotine than their American counterparts and are marketed to teens with fruity flavors such as Sakura Grape and Pineapple Coconut Ice. Furthermore, due to the illicit nature of Chinese vapes, authorities such as FDA commissioner Robert Califf say they've grown increasingly concerned the products could be laced with fentanyl.

Ironically, the Chinese Communist Party has done more to ban the sale of flavored disposable vapes manufactured within China's borders than the FDA has done within U.S. borders. Chinese authorities in October outlawed the sale of all flavored e-cigarettes, though they still allow for the manufacture and export of such products.

The Elfbar purchased by the Free Beacon on Thursday was manufactured in China specifically for sale in the United States, according to a disclosure on the product's box.

The Biden administration says going after retailers is the centerpiece of its strategy against the Chinese products.

"I've been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well-known to appeal to youth," said Brian King, the director of the FDA's Center for Tobacco Products. "Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we're committed to taking appropriate action."

This is not the first time the White Oak Convenience Store has been exposed for selling outlawed Chinese disposable vapes. The Daily Mail reported in March that the store was selling illegal vapes. Many of the same outlawed products were available for sale within plain sight behind the cashier counter when the Free Beacon visited on Thursday.

It is unclear how the FDA missed the vapes during its inspection. The FDA did not return a request for comment.

Jim Carroll, who was the director of the Office of National Drug Control Policy under former president Donald Trump, says that the FDA's failure to catch a retailer located right next to its headquarters is "egregious."

"The fact that illegal, disposable, Chinese vapes in kid-friendly flavors are being sold in the FDA's own backyard is nothing short of egregious," Carroll said. "The FDA and Biden administration cannot waste any more time—they must make this a top priority and get illegal Chinese disposable vape products off of store shelves."

Carroll also said the action against American manufacturers of vapes has been much more stringent.

"The administration took efforts against products such as Juul that was swift, clear, and decisive," he said. "We're not seeing that now on products on the flavored disposable vaping pens coming from China. Why have we not seen action taken? I don't know, and it worries me."

The post The Biden Admin Says It's Cracking Down on Illegal Chinese Vapes. You Can Still Buy Them Next Door to the FDA. appeared first on Washington Free Beacon.

The Centers for Medicare and Medicaid Services—a federal agency within the Department of Health and Human Services that administers Medicare—is, in almost all cases, refusing to cover an Alzheimer's treatment that research shows can reduce cognitive decline by 27 percent. The decision, a new University of Chicago study argues, could cost Americans up to $546 billion in private and public spending, as patients who deteriorate without the drugs require additional health care spending that Medicare does cover.

In addition to the sizable burden on taxpayers, the administration's refusal to cover the new treatments outside of selective clinical trials contradicts the health department's self-described commitment to "health equity." The Centers for Medicare and Medicaid Services on Wednesday and Thursday held its first ever "Health Equity Conference," which aimed to highlight and address "health disparities" in rural and "underserved communities." Those communities, however, are often unable to participate in clinical trials, which typically take place in heavily populated areas that include universities or large medical centers. 

The University of Chicago study's co-author, professor Tomas Philipson, criticized the administration for creating "barriers to care" that "not only deny patients innovative relief but also hope."

"Millions of Americans are all too familiar with the human cost of Alzheimer's, but this study makes clear the personal and financial suffering caused by red tape that withholds potentially life-altering relief from patients," Philipson said. "The tragedy of Alzheimer’s disease is exacerbated by inaction of policymakers. We hope lawmakers will heed this report’s findings outlining the lost opportunity and harm caused by onerous regulations."

In 2021, the Food and Drug Administration granted accelerated approval for amyloid plaque-targeting treatment in Alzheimer’s patients, which studies have shown delays cognitive decline caused by the disease. In April of 2022, however, Biden's health department implemented a coverage restriction that limited Medicare coverage for the treatment to those who participate in certain clinical trials. As a result, patients who are prescribed the treatment outside of a clinical trial have to pay out of pocket, and it may take as long as 17 years to reverse the restriction, according to the University of Chicago white paper.

In December, the national Alzheimer’s Association formally requested the Centers for Medicare and Medicaid Services reconsider its coverage determination, citing clinical studies the association said "clearly demonstrate a meaningful clinical benefit" of the plaque-targeting treatments for Alzheimer patients. Even the Food and Drug Administration says the treatment has shown "statistically significant treatment effects."

In addition to the two groups, a bipartisan coalition of nearly 100 members of Congress in February wrote Biden's health secretary, Xavier Becerra, to call for the coverage restriction to be removed, arguing that the restriction could bring "irreversible disease progression for beneficiaries living with Alzheimer's." 

"Patients, families, and caregivers living in rural and underserved areas should have the same opportunity for access to treatment," the letter says. "It is an enormous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to limited research institutions that host the trials."

The Food and Drug Administration is expected to weigh traditional approval for one plaque-targeting drug in the coming weeks. But even if the drug does get the okay, Medicare and Medicaid will only cover it "when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry."

The development of a registry can take many years, Philipson noted in his study, causing the coverage restriction that prevents patients from getting treatment to persist, despite full federal approval.

"With this approach, only the privileged few with access to clinical trials have access to treatment," the Alzheimer's Association stated in a press release. As a result, the association said, the Biden administration policy "exacerbates and creates further health inequities among those who are already disproportionately impacted by this fatal disease."

The Centers for Medicare and Medicaid Services told the Washington Free Beacon it would "continue to look carefully at the evidence and wait for the FDA’s decision on whether to grant traditional approval."

"CMS is committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for Alzheimer’s disease," senior communications adviser Sara Lonardo said. "If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare who meets the criteria is covered," Lonardo concluded. 

Thomas McKenna contributed to this report.

The post How the Biden Admin's Refusal to Cover New Alzheimer's Drugs Hurts 'Underserved' Americans and Costs Taxpayers Billions appeared first on Washington Free Beacon.

The Food and Drug Administration announced last week it will purchase the chemotherapy drug cisplatin from China's Qilu Pharmaceutical in a bid to alleviate what one expert called "one of the worst chemotherapy drug shortages in history." Chinese authorities investigated Qilu, one of the country's largest drugmakers, in 2012 for using discarded cooking oil from restaurants to make antibiotics. The FDA has not approved cisplatin for use in the United States but has granted a temporary waiver to combat a chemotherapy supply chain crisis that has caused widespread delays in treatment for lung, cervical, and other cancers.

The supply chain snafu threatens to derail President Joe Biden's pledge to "end cancer as we know it." Congress has appropriated $1.8 billion since then-vice president Biden launched his "Cancer Moonshot" in 2016. The president in 2022 "reignited" the moonshot and this March asked Congress for an additional $2.8 billion in funding. Researchers say a cure for cancer is still far off.

American lawmakers and medical experts have long called for the FDA to investigate foreign suppliers of raw materials for drugs. Investigative journalist Katherine Eban told the U.S.-China Economic and Security Review Commission in 2019 that China remains "a continuing source of adulterated drug products" and that the FDA has "found widespread fraud and manipulation of quality data in Chinese manufacturing plants." Sen. Chuck Grassley (R., Iowa) in 2019 called on the FDA to ramp up its inspections of overseas drug manufacturers that produce materials for American pharmaceuticals. Grassley noted that 80 percent of raw materials used in American drugs come from China and India.

Gutter oil, which is considered highly toxic and contains carcinogens, has been widely used in China's restaurants and food manufacturers for decades as an alternative to more expensive cooking oils. Qilu accepted responsibility for using gutter oil in its drugs but claimed it was unaware of the ingredients used by its suppliers.

The gutter oil scandal was part of a broader pattern of Chinese drugmakers using "cut-rate practices" to manufacture drugs, drug industry trade publication Fierce Pharma said at the time.

Chinese drugmakers have been at the center of several high-profile tainting scandals. Eighty-one Americans died in 2008 after taking the heart drug heparin, which was supplied by a Chinese company that used contaminated raw materials derived from pigs. And in 2018, the FDA recalled the Chinese-made valsartan, a blood pressure drug found to contain carcinogenic materials.

The FDA and Qilu did not respond to requests for comment. But FDA chief Robert Califf said last week, after the Qilu partnership was announced, that the agency will "very carefully assess product quality" and require its partners to "ensure the products are safe for patients."

The post Facing Chemo Shortage, Biden Admin Taps Chinese Company That Made Drugs With Toxic Sludge appeared first on Washington Free Beacon.

"You’re telling me that my 21-year-old son can buy all the cannabis he wants, but my grandmother who’s been smoking for 65 years can’t get a cigarette? It doesn’t make sense," said Corey Pegues, a retired black New York Police Department executive who is urging lawmakers to reject Hochul’s proposal.

Pegues said the governor’s proposed legislation, which was tucked in her Jan. 10 State of the State plan, will disproportionately affect black voters. Critics say the proposal came as a shock to outside experts who would have warned about the policy’s racial bias.

Hochul is the latest Democrat to anger black activists with a flavored tobacco ban. Eighty-five percent of black smokers use menthol cigarettes, compared with just 30 percent of white smokers, according to the CDC. Experts warned that the Biden administration’s 2022 proposal to ban flavored tobacco products would be a boon for criminal cartels who would become the only source for menthol smokers to get their fix. Critics of Hochul’s proposal echoed those claims, noting that increased crime in black neighborhoods could further exacerbate tension with the police.

Activists told the Washington Free Beacon that if Hochul gets her way, she will risk losing political support from their community, a critical voting bloc that helped her win her first full term in 2022.

"Hochul didn't run on this. She would have been defeated. Black people wouldn’t have voted for her," Pegues said. "Whoever passes this ban is going to be the boogeyman. Think about this. You are going to be the person that took Newport cigarettes from black people. You would never get reelected again, I promise you."

Wayne Harris, chairman of the board of the Law Enforcement Action Partnership, said Hochul is "specifically targeting people of color" with her proposed ban. Hochul said her policy, if approved by the New York State Legislature, would prevent 22,000 youths from becoming adult smokers.

But Harris noted that flavored cigarettes are no more addictive than their natural counterparts and questioned why the governor has no apparent interest in banning tobacco products preferred by white people. Harris also pointed out that youth smoking rates have decreased substantially in recent decades.

"Our youth are much more likely to be smoking marijuana than they are to be smoking cigarettes," Harris said.

Hochul's office defended the governor's efforts to "prevent senseless deaths" but did not offer a response to the concerns expressed by the black activists.

"With commercial tobacco use the leading cause of preventable deaths, Governor Hochul is leading the way to a tobacco-free generation to reduce youth smoking and prevent senseless deaths," Hochul press secretary Hazel Crampton-Hays told the Free Beacon. "As with any budget proposal, we will work with the legislature on the final details for the best way to protect public health."

New Yorkers will have no problem getting their hands on flavored marijuana products. A nonprofit weed dispensary operating in Manhattan is legally marketing flavored THC products with names such as "Tropical Runtz," "Pink Grapefruit," and "Cereal Milk," the New York Post reported.

Jiles Ship, a former president of the National Organization of Black Law Enforcement Executives, said New Yorkers will turn to the black market to get their menthol fix if Hochul’s proposed ban becomes law.

"They’ll go to other states and get them," Ship said. "They’ll bring them back to New York and then try to sell them on the black market, which is going to create another crime problem in the communities because now people will be having turf wars, and a multitude of illicit activities will transpire."

Even Hochul’s fellow Democrats have come out against the proposed ban. Assemblyman Nader Sayegh, a Democrat representing Yonkers, called it a "harsh" and "unjust" piece of legislation.

"It’s not equitable to say: ‘Stop smoking hookah but you can go smoke pot,’" he told the New York Post.

A source with knowledge of the inner workings of Hochul’s office told the Free Beacon that the proposal was the brainchild of her policy director Micah Lasher. Seen as a political "wunderkind" in New York Democratic circles, Lasher rose to prominence in 2001 for producing a racist flier showing then-Democratic New York City mayoral candidate Fernando Ferrer kissing Rev. Al Sharpton’s rear end. Sharpton never forgave Lasher for the flier, saying as recently as December 2020 that the operative was a "bigoted strategist."

Lasher also shares extensive ties with billionaire Democrat Michael Bloomberg, whose eponymous charity Bloomberg Philanthropies has doled out $1.58 billion since 2005 on anti-tobacco initiatives. A founding partner of the storied Democratic consulting firm SKDKnickerbocker, Lasher helped manage Bloomberg’s New York City mayoral campaigns in the early 2000s. Lasher led Bloomberg’s legislative agenda from 2010-2013, including the mayor’s infamous effort to ban soda sales in the Big Apple.

The post Up in Smoke: Black Activists Slam Kathy Hochul for Proposed Menthol Cigarette Ban appeared first on Washington Free Beacon.

Biden, the first octogenarian president in American history, is expected to formally announce his plans to seek a second term sometime next month, thus setting the stage for a potential rematch against Donald Trump.

The president is going to need all the help he can get to mitigate the rapid deterioration of his brain before Election Day in 2024, which is probably why his administration fast-tracked the new Alzheimer's drug, Leqembi, using its "accelerated approval" designation. The new drug also carries some risk, as a significant percentage of patients in clinical trials experienced swelling and bleeding in the brain after taking Leqembi.

Whereas Trump has no discernible flaws, Biden has been widely criticized as "too old to be president." He would be 86 by the time he left office after two terms and has already exceeded the average life expectancy for American males by several years. His cognitive decline is glaringly obvious to anyone who has watched him attempt to speak in public. A recent CNBC poll found that 70 percent of Americans, including a majority of Democrats, don't want Biden to run for reelection.

Biden has repeatedly refused to subject himself to independent testing that could shed light on his cognitive health, or lack thereof. When CBS reporter Errol Barnett asked Biden in 2020 if he would take a cognitive test to allay voter concerns about his health, the then-candidate responded by accusing the black journalist of being a "cocaine" "junkie."

Trump, by contrast, is renowned for his superhuman stamina and has aced every cognitive test he's ever taken. An esteemed doctor famously described him as "the healthiest individual ever elected president."

WATCH: Two Minutes of Joe Biden Wandering Around Looking Lost

The post FDA Fast-Tracks New Alzheimer's Drug in Boost to Biden's Reelection Bid appeared first on Washington Free Beacon.

Bloomberg Philanthropies and the Bill and Melinda Gates Foundation have teamed up, spending over $100 million since 2017 on grants, research, and other nonprofits all dedicated to outlawing nicotine products. The Robert Wood Johnson Foundation has to a lesser degree joined this effort, giving over $20 million since 2017. In total, the money amounts to an enormous crusade to undercut vaping and non-combustible tobacco products.

But the push also comes amid mounting evidence that smoking alternatives provide a significantly healthier alternative to traditional cigarettes and cigars. Some of the very groups working to ban vaping products from the U.S. market, including Truth Initiative, concede that vaping could dramatically lower smoking rates.

The biggest contributor to the anti-vaping effort is Bloomberg Philanthropies, the eponymous charity started by billionaire Democratic megadonor and former New York City mayor Michael Bloomberg. Since 2017, his charity has given large sums of money to anti-tobacco organizations such as the Campaign for Tobacco-Free Kids.

That group, which has received at least $60 million from Bloomberg, has called for the elimination of all flavored vaping products as well as popular vapes such as Juul. For months, the Campaign for Tobacco-Free Kids lobbied the FDA to deny Juul's marketing application, which would effectively shut down the company.

The FDA in June concurred with the Campaign for Tobacco-Free Kids's position. The move earned applause from the group, calling the FDA's decision "the most significant action … to reverse the youth e-cigarette epidemic" in the agency’s history.

The Campaign for Tobacco-Free Kids spent just under $1 million on lobbying efforts in the lead-up to the FDA's decision this year, federal records show. Among the firms hired included NVG LLC, a Democratic-connected lobbying firm with a focus on FDA-related issues.

Experts warned that outside lobbying efforts could steer the FDA away from making scientifically sound decisions on vaping devices. Dr. Cliff Douglas, the former vice president for Tobacco Control at the American Cancer Society, wrote last year that "tobacco control organizations" such as the Campaign for Tobacco-Free Kids "have applied inordinate pressure on the FDA."

"FDA's scientific review process must be protected," Douglas wrote. "Unfortunately, unless the warring factions find ways to join hands in support of the health and well-being of everyone, youth and adults alike, the heat and rhetoric around these questions may only increase, and so will the cost to the health of our nation."

The Campaign for Tobacco-Free Kids did not respond for comment. Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and the Robert Wood Johnson Foundation did not respond to requests for comment.

Other Bloomberg-backed groups, including Vital Strategies, pushed for the ban as well. Vital Strategies, which describes itself as a public health organization dedicated to "reimagining public health," has called for the complete elimination of tobacco products worldwide.

Bloomberg Philanthropies has given over $42 million to Vital Strategies since 2017. Just under half of those funds, $20 million, have been earmarked for a "global tobacco industry watchdog" named Stopping Tobacco Organizations and Products. Vital Strategies says it is a "main partner" in Bloomberg's $1 billion initiative to "reduce tobacco use."

Bloomberg Philanthropies is also in an explicit partnership with the Bill and Melinda Gates Foundation, founded by billionaire and former Microsoft CEO Bill Gates. The foundation gave $4 million in 2019 to Bloomberg Philanthropies for anti-tobacco initiatives, including Vital Strategies, according to publicly available tax forms.

That same year the Gates Foundation committed over $60 million to the left-wing advocacy group the New Venture Fund. That grant was specifically earmarked for, among other things, "tobacco control."

Industry groups, such as the American Vaping Manufacturers Association (AVMA), have said the vaping regulatory process is corrupted by the outside influence of these groups.

"This crucial public health issue, which ought to be guided strictly by scientific analysis, has been gripped in a stranglehold by pompous tycoons utterly unaccountable to anyone," AVMA president Amanda Wheeler said in a statement to the Washington Free Beacon. "The effect is that countless Americans are being deprived of the single most effective smoking cessation method ever. That ought to be a national scandal."

A lesser-known organization, the Robert Wood Johnson Foundation, led by former president Barack Obama's CDC director Richard Besser, has given nearly $12 million to the Campaign for Tobacco-Free Kids since 2017. The Robert Wood Johnson Foundation has funded other efforts as well, giving nearly $3 million in 2020 to the Public Health Law Center.

The Public Health Law Center this year released a "Policy Playbook for E-Cigarettes" in conjunction with the Vaping Prevention Resource, the self-described "leading online destination for vaping prevention media."

Among other policies, the policy playbook recommends that local governments restrict the number of vape retailers by setting "an absolute cap on issuing new licenses," with the aim of fewer tobacco sellers in the targeted area. Some states, such as New York, have embraced that policy, while others, such as Connecticut, have said it will lead to black markets.

In recent years the Democratic Party has increasingly targeted tobacco products. Along with deciding to end the sale of Juuls, President Joe Biden's FDA issued a rule banning menthol cigarettes and a regulation to significantly cut back the amount of nicotine in non-flavored cigarettes.

Democrats also proposed a tax on all vaping products in their initial budget reconciliation bill that later became the Inflation Reduction Act. That plan would have taxed vape products at a rate of $50.33 for every 1,810 milligrams of nicotine they contain.

The post How Three Liberal Nonprofits Drive the Anti-Vaping Campaign appeared first on Washington Free Beacon.

A number of videos challenged people to cook chicken in NyQuil, which contains acetaminophen, dextromethorphan, and doxylamine, or another similar over-the-counter cough and cold medication, according to the FDA.

Boiling medicine can make it much more concentrated and change its properties in other ways, the FDA said in a notice dated Sept. 15.

"Even if you don't eat the chicken, inhaling the medication's vapors while cooking could cause high levels of the drugs to enter your body. It could also hurt your lungs."

This is not the first time the FDA has warned against social media challenges that use non-prescription medicine.

In September 2020, a similar warning was issued by the FDA after reports of teenagers getting admitted to emergency rooms or dying after participating in the "Benadryl Challenge" on the short-video app.

(Reporting by Khushi Mandowara in Bengaluru; Editing by Shounak Dasgupta)

The post Chinese-Owned TikTok Convinces Teens to Marinate Chicken in NyQuil appeared first on Washington Free Beacon.

The vaccine in question, manufactured by Moderna, targets both the original virus and the Omicron variant. It is "a sharpened tool in our armory to help protect us against this disease," June Raine, the head of Britain's Medicines and Healthcare Products Regulatory Agency, said in a statement.

It is also a key part of the Biden administration’s plan to roll out updated boosters in September. But the Food and Drug Administration has yet to approve the new shot, even as health officials warn that the United States could see as many as 100 million coronavirus cases this fall.

It’s not the first time British regulators have beaten the FDA to the punch. On December 2, 2020, the United Kingdom became the first country to authorize the original Pfizer vaccine, a head start that helped it vaccinate its population much faster than the United States. The United Kingdom also began planning its initial booster campaign in June 2021, just as the Delta variant was taking off. FDA officials, on the other hand, were insisting as late as September 2021 that boosters were unnecessary.

The contrast highlights the paradox of the U.S. pandemic response: From mRNA vaccines to antivirals, the United States has produced nearly every tool in the world’s pharmaceutical arsenal against COVID-19 but has often been slow to take full advantage of these tools, hamstrung by the bureaucratic caution that defines U.S. regulatory culture.

In early 2021, for example, the FDA insisted that doses of the coronavirus vaccine be given three weeks apart, in keeping with the terms of its emergency use authorization. That by-the-book approach strained scarce supplies and prolonged the wait for first doses, which provided significant protection on their own. By contrast, U.K. regulators delayed the second shot in order to get first doses to as many people as possible.

Political forces have exacerbated the FDA’s foot-dragging. The first version of the coronavirus vaccine was on track for approval in October 2020 until the FDA pumped the brakes, telling Pfizer and Moderna it wanted more safety data before signing off on the shots. Scientists and FDA officials were concerned that releasing the shots before the November election—as President Donald Trump had promised to do—would undermine trust in the vaccine.

The FDA didn’t approve Pfizer’s vaccine until December 11, 2020. The delay, the economist Garrett Jones estimated, may have cost more than 100,000 lives.

The post UK Beats the US to Release of Latest Moderna Vaccine. It’s a Pattern. appeared first on Washington Free Beacon.

According to an Echelon Insights poll obtained by the Washington Free Beacon, 52 percent of Pennsylvania voters say menthol cigarettes should remain legal. A majority of women, Hispanics, and independent voters oppose the ban, which Biden proposed in April 2021 to "address health disparities experienced by communities of color, low-income populations and LGBTQ+ individuals."

The poll suggests any ban on menthols could further erode Biden’s standing in the Keystone State, where the president has just a 39 percent approval rating. Forty-seven percent of Biden voters oppose the ban, while 39 percent support it. Democrats oppose the ban by a 44-37 margin. Pennsylvania attorney general Josh Shapiro, the Democratic nominee for governor, has called on the Food and Drug Administration to ban the cigarettes. Lt. Gov. John Fetterman, the Democratic Senate nominee, has not weighed in on the issue, though he does support a soda tax that is also unpopular with voters.

The poll, which surveyed 603 registered voters in early July, mirrors similar findings in Georgia, North Carolina, and Nevada. A majority of voters in those states oppose the menthol ban, according to an April Echelon poll.

Progressive groups have opposed the ban, arguing that it will have unintended consequences for minorities, who tend to prefer menthols over traditional cigarettes. Eighty-five percent of black smokers prefer menthols over other cigarettes, according to the Food and Drug Administration. The American Civil Liberties Union said Biden’s proposal was a "policy disaster waiting to happen" and would "disproportionately impact communities of color, result in criminalization of the market, and exacerbate mass incarceration."

Violent crime remains a far more important issue to voters than the proposed menthol ban, according to polling. Ninety-five percent of respondents in the Echelon poll say other issues are more important than the ban. In Philadelphia, Pennsylvania’s largest city, 70 percent of residents say crime and public safety are the most pressing issues. Just 36 percent of residents there support a ban on menthols, versus 49 percent who want to keep them legal.

The post POLL: Majority of Pennsylvanians Oppose Biden's Menthol Cigarette Ban appeared first on Washington Free Beacon.

The monkeypox vaccine is supposed to be given in two doses spaced 28 days apart, per guidance from the Food and Drug Administration and the Centers for Disease Control and Prevention. But with supplies scarce—and with both agencies under fire for their sluggish response to the outbreak—some jurisdictions are taking matters into their own hands. New York City and San Francisco, which have the first and second-largest number of monkeypox cases in the United States, respectively, are now prioritizing first doses of the vaccine for high-risk individuals, even if it means some recipients need to wait longer for their second shot.

The one-dose strategy is a "much better" approach, Peter Chin-Hong, an infectious disease expert at the University of California, San Francisco, told Forbes on Wednesday. Though the FDA and CDC have warned that one dose offers insufficient protection from monkeypox—a disease three times as lethal as COVID—Chin-Hong stressed that some protection is better than none.

"There's nothing magical about spacing vaccines the way they're spaced on the label," Chin-Hong said. "You can catch people back up with their second doses later."

A similar debate unfolded in the early days of the coronavirus vaccine rollout, when federal regulators insisted the scarce mRNA vaccines be given in two doses three weeks apart, in keeping with the terms of the FDA's Emergency Use Authorization. That intransigence sparked criticism from some immunologists and health care experts, who warned that the bureaucratic caution was costing lives. A "first doses first" strategy, libertarian economist Alex Tabarrok argued in the Washington Post, would let the United States vaccinate its population more rapidly and hasten the end of the pandemic.

That argument proved correct: The British government accelerated its vaccination program by allowing a 12-week interval to elapse between shots, which turned out to provide stronger immune response in the long run.

The federal government's monkeypox response has so far ignored these lessons. Both Rochelle Walensky, the director of the CDC, and Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, are urging states to stick to the approved dosing schedule, even as the prospects of containing monkeypox continue to dim.

That some localities have shrugged off the agencies' advice may be a sign that the agencies' legitimacy is waning—including among the blue states typically friendly to federal regulators. From masks to vaccines to monoclonal antibodies, many liberal cities took their cues from the CDC throughout the coronavirus pandemic. Now, with cases of monkeypox overwhelmingly concentrated in those cities' gay populations, blue enclaves are embracing the federalism they scorned in 2020, experimenting with public health policies that don't have the government's seal of approval.

"New York City is the epicenter of the monkeypox outbreak in the U.S. and yet does not have sufficient vaccine supply to reach the number of people who need it protect themselves," New York City's public health department said in a statement. "Given the rapid increase in cases, the Health Department has decided that providing first doses to offer protection to more at-risk New Yorkers is the best strategy."

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The U.S. Court of Appeals for the District Of Columbia Circuit said the purpose of the stay was to allow the court sufficient time to consider Juul's briefing for an emergency review and not a ruling on the merits of that motion.

The once red-hot vape company has also been working with its legal advisers on options that include a possible bankruptcy filing if it is unable to get relief from the government's ban, the Wall Street Journal reported, citing people familiar with the matter. (https://on.wsj.com/3zZKXiz)

Juul's counsel Kirkland & Ellis is advising on the contingency plans, according to the report.

The FDA said on Thursday Juul failed to show the sale of its products would be appropriate for public health, following a nearly two-year-long review of data provided by the company.

Juul, partly owned by tobacco giant Altria Group Inc, said it disagreed with the agency's findings.

The temporary freeze on the FDA order lasts at least until July 12, according to the court's scheduling order.

The pause gives Juul time to argue for why the order should be placed on hold for a longer amount of time pending the court's review of it. The D.C. Circuit can extend the pause on the agency's order, or it can let the order take effect while Juul's appeal is pending.

The FDA and Juul declined to comment.

Juul said the FDA's decision to block sales of its products was "extraordinary and unlawful", citing, among other things, the agency authorizing similar e-cigarette products made by competing manufacturers.

BAT's Vuse Solo was the first e-cigarette to get the agency's clearance in October.

Juul also said the FDA's ban was a departure from the agency's normal practices, which typically involve allowing a transitional period, and questioned the agency's "immense political pressure from Congress".

(Reporting by Deborah Sophia and Uday Sampath in Bengaluru; Editing by Shinjini Ganguli, Maju Samuel and Shounak Dasgupta)

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The removal is part of an effort at the FDA under President Joe Biden to reduce nicotine consumption and nicotine levels in U.S. products. The agency announced in June it will also develop a proposed rule to establish a maximum nicotine level in cigarettes and other tobacco products.

The move comes on the heels of efforts by Democrats to hit tobacco suppliers after they had added a tax on vapes last year to the Build Back Better Act. The bill passed the House but was never taken up in the Senate. The $75 billion U.S. tobacco industry is likely to take another hit following the FDA's proposed rules for nicotine regulation.

Experts who spoke with the Washington Free Beacon emphasized that the FDA's decisions will only kneecap the domestic tobacco industry and benefit a burgeoning black market.

The FDA has targeted Juul Labs, Inc., for the past four years, blaming the $10 billion vaping company for appealing to underage people with flavors like mango and crème brûlée. The company stopped selling sweet and fruity flavors in 2019, decreasing their sales. The agency also has floated plans to ban menthol cigarettes.

Juul may pursue an appeal through the FDA, challenge the decision in court, or file a revised application for its products.

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An estimated 25 percent of Department of Health and Human Services employees neglected to log on to the agency's software suite, which includes their email, work files, video conference calls, and other applications needed to perform remote work, according to the internal documents. The report, commissioned by then-HHS chief of staff Brian Harrison, measured employees' inactivity on a day-to-day basis between March 2020 and December 2020. The documents, portions of which were leaked by a whistleblower to the Functional Government Initiative and reviewed by the Free Beacon, state that all HHS employees had secure access to these accounts to work remotely.

Federal employees have begun to return to the office in recent months, but the Biden administration has explored ways to make pandemic telework policies permanent. The effort is backed by House Democrats, who on Wednesday advanced a bill that would require agencies to provide advance notice to Congress and the Office of Personnel Management if they want workers to return to the office.

Harrison, now a Republican state representative in Texas, said he grew concerned in the early months of the pandemic that lenient telework policies led to inefficient output from employees. He said he began to track office attendance and found fewer than 10 percent of employees showed up at certain points in 2020. The discovery led him to conduct a comprehensive review of how much remote work employees were doing. 

"Almost everyone was home at the federal health agency responding to a pandemic—I found that problematic and worked to safely increase those numbers," Harrison told the Free Beacon. "Biden sent everyone back home, and you can't run HHS like that effectively."

Harrison did not receive the results of the report until January 2021—a week before the Biden administration took over. Biden on his first day in office issued an executive order that included a mask mandate for federal workers and directed agencies to explore new telework policies. The Office of Management and Budget, which oversees the operation of all federal agencies, implemented guidance days later that stated: "Every effort will be made to maximize the use of remote work during widespread community transmission."

Harrison said it is likely that these new telework policies have only worsened work participation. A top official at the Food and Drug Administration admitted the agency lost a 34-page whistleblower report sent in October 2021 that warned about an imminent baby formula shortage, which became a rampant issue for the Biden administration by May. The report, lost in an FDA mail room, did not reach the department's food policy deputy commissioner until February. FDA commissioner Robert Califf said the lost document was a "technical issue" that could be attributed to poor coordination at the agency.

Peter McGinnis, the communications director for the Functional Government Initiative, said the Biden administration's push for unnecessary telework has harmed taxpayers.

"Work from home? Perhaps not working at all," McGinnis told the Free Beacon. "Sadly, this dysfunction now threatens the health of mothers and children."

House Republicans introduced a bill in May that would reestablish pre-pandemic telework policies for federal workers and require agencies to submit a report on the impact of their telework policies since 2020. Rep. Yvette Herrell (R., N.M.), who sponsored the bill, said the Biden administration needs to justify the need for expanded telework to taxpayers.

"Extending pandemic-era telework for no good reason hurts Americans who need in-person attention and care," Herrell told the Free Beacon. "The first priority of public employees should be to serve their employers, the American people."

HHS, which employs more than 80,000 workers and requested a mandatory budget of $1.7 trillion for 2023, did not respond to a request for comment.

Herrell said the negative impact of telework goes beyond HHS. CNN reported that in the first week of Biden's presidency several White House national security workers were forced to return to remote work, which prevented them from accessing classified materials crucial to their jobs. The Internal Revenue Service this year has seen historic delays in tax returns that have left its facilities full of unchecked paperwork. The Department of Veterans Affairs has similarly struggled with overdue disability claims amid the pandemic.

Previous administrations debated telework policies before the pandemic. The Obama administration expanded telework opportunities, but these programs were reduced under former president Donald Trump.

Sen. Richard Burr (R., N.C.) has pressed several federal agencies to provide more information on the impact of their telework policies, saying they have hindered the administration's ability to address ongoing crises, including the baby formula shortage.

"Americans expect accountability from an agency that deals with some of the nation's most difficult and complex challenges," Burr told the Free Beacon.

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In the last five months alone, the multibillion-dollar Packard Foundation has sent more than $3.5 million to groups that advocate for the abortion pill, its grant disclosures show. Some of those groups, such as Planned Parenthood of Northern New England, distribute the pill in traditional, legal settings. But another grantee, nonprofit DKT International, manages websites that encourage users to obtain abortion pills through an international provider. That provider, Austrian-based nonprofit Aid Access, uses "telemedicine abortion" to mail the pills to all 50 states, even those that have banned the practice. Packard gave DKT $500,000 in 2022.

The controversial scheme provides a window into how deep-pocketed liberal groups are fighting to maintain abortion access should the Supreme Court overturn Roe. In addition to DKT's overseas abortion pill promotion, the group exclusively distributes a line of manual vacuum aspirators that are used to perform abortions. One Minnesota-based nonprofit, Abortion Delivered, plans to use such aspirators to perform abortions in mobile vans dispatched just outside red states if the Court strikes down Roe.

The Packard Foundation, which did not return a request for comment, has not been shy about its desire to use abortion to curb population growth. Roughly a decade before his death in 1996, tech billionaire David Packard penned a letter to his children that condemned skyrocketing birth rates, which he said would cause "utter chaos for humanity." The foundation's "highest priority," Packard wrote, "must be to reduce worldwide population growth" through abortion and other avenues.

DKT promotes international abortion pills through a sister organization, Women First Digital. One of the group's websites, HowToUseAbortionPill.org, features a chat function that helps women obtain abortion pills. Users who indicate they are in the United States and would like to purchase pills online are automatically referred to two "highly trusted online partners" that help send women abortion pills from overseas. Both of those "partners," Women on Web and Women Help Women, encourage Americans in all 50 states to obtain abortion pills through Aid Access.

DKT's HowToUseAbortionPill.org also directs visitors to Plan C. The nonprofit assures women in states "that restrict access to telehealth abortion" that abortion pill access is "still possible" thanks to Aid Access and other online pharmacies. Plan C acknowledges that the practice is legally questionable—its FAQ page says that while "no one should ever be punished for providing their own medical care," at least "60 people who have self-managed an abortion or have helped someone else are known to have been arrested or prosecuted."

"People who live in very conservative states also face a higher risk of prosecution," Plan C's site notes.

The websites help Aid Access spread awareness about their service to women in the U.S., a difficulty for the overseas abortion pill provider after Google updated its algorithm in 2020. Because of the change, Aid Access is no longer listed as a top result when users search terms such as "abortion by mail" and "abortion pills." Sites such as HowToUseAbortionPill.org, therefore, serve as important intermediaries through which Aid Access can recruit customers.

Nineteen states ban the use of telemedicine for abortion, and others may move to prohibit telemedicine abortion consultations in their states if the Supreme Court strikes down Roe. But Aid Access has already evaded regulatory challenges in the United States. After the Food and Drug Administration in 2019 sent the nonprofit a cease-and-desist letter, Aid Access sued the federal agency. The FDA did not follow through on its threat, and the lawsuit was subsequently dismissed.

Still, experts expect international abortion pill providers such as Aid Access to face additional legal threats if Roe is overturned. According to the nonprofit's founder, Dutch doctor Rebecca Gomperts, Aid Access saw an "incredible increase" in abortion pill requests after Texas passed its "Heartbeat Act," which bans abortion when there is a detectable heartbeat. Gomperts expects a similar surge if the Court overturns Roe.

Aid Access mails abortion pills to women prior to or during pregnancy and covers costs for those who claim to be financially vulnerable. The organization's website directs women to complete an online form so that they can be prescribed the pills by a European doctor who approves them to be mailed from a manufacturer in India.

Abortion by pill consists of two drugs. The first, mifepristone, is taken to cut off the hormone supply to the fetus, which stops development. Users then take misoprostol, which contracts the uterus and delivers the remains. Complications from these chemical pill abortions, which often include excessive hemorrhages and bleeding, are four times higher than surgical abortions.

Mifepristone can only be prescribed in the United States by certified, FDA-approved health care providers. The federal agency first approved mifepristone in 2000 under the brand name Mifeprex and has since cut back on regulations targeting the drug. Before the coronavirus pandemic, the FDA required mifepristone users to visit a doctor in person prior to taking the drug. The Biden administration in April 2021 temporarily lifted that requirement, a decision the FDA made permanent in December.

Lawmakers in eight states this year proposed outright bans of chemical abortion pills, but none was enacted. Other restrictions that prolong the process to obtain mifepristone were blocked in court thanks to lawsuits filed by Planned Parenthood and other liberal organizations.

The Supreme Court is set to overturn Roe this summer, according to a draft leaked to Politico. The move would allow states to restrict abortion prior to the current standard of fetal viability at roughly 24 weeks.

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Mifepristone, known as Plan C, can be prescribed to terminate a developing fetus up to 10 weeks into a pregnancy and has four times the complication rate of surgical abortions. But its usage has steadily increased since it was approved by the FDA in 2000. A February study from the pro-abortion Guttmacher Institute found that the chemical pills accounted for 54 percent of abortions in 2020—a sharp increase from 39 percent in 2017.

Deregulation efforts from the Biden administration are expected to continue this trend. The FDA in December removed its requirement that women get an in-person doctor visit to receive a mifepristone prescription. The move came after more than 70 Democratic politicians in August signed a resolution, backed by Planned Parenthood Federation of America and NARAL, that called on the FDA to make permanent its pandemic policy that allowed women to get mifepristone via mail after a virtual doctor appointment.

Sue Liebel, the state policy director for the pro-life Susan B. Anthony List, said the deregulation efforts are a clear example of the cozy relationship between Democrats and the abortion lobby.

"The Biden administration is putting the lives of women and their unborn children at risk to boost the abortion industry's profits," Liebel told the Washington Free Beacon. "Ironically, the FDA is ignoring the science about the serious risks of chemical abortion."

The Obama administration in 2016 ended a requirement that mifepristone manufacturers report adverse events such as hemorrhages and ectopic pregnancies that did not result in death. The FDA cited the same database on adverse effects, which also never required emergency rooms to report complications from the drug, to justify its December deregulation.

Studies that track reports from emergency rooms show a complication rate up to 10 times greater than that of studies that rely on data from the drug's manufacturer. Tessa Longbons, a senior research associate at the Charlotte Lozier Institute, said it is unacceptable for the FDA to rely on data from companies that profit off the pills.

"I can think of no other public health issue in which self-reported industry data is considered acceptable by policymakers or parroted endlessly by the mainstream media," Longbons said.

The rate of emergency room visits related to the usage of chemical abortion medicine increased more than 500 percent between 2002 and 2015.

Longbons noted that the Guttmacher study on chemical pill usage provides an incomplete picture because it relies on data from abortion providers. States are not required to report data on abortions, and the study leaves out three blue states that account for an estimated one-fifth of abortions in the United States: California, Maryland, and New Hampshire. The study also does not track the use of black market chemical abortion pills, which have increased in usage in states with more regulations.

Republican legislatures are pushing their states' health departments to reestablish stricter regulations of mifepristone in response to the December FDA decision. Four states introduced legislation that would ban telemedicine for mifepristone. Nine other states have introduced bills that would limit access to chemical abortion pills, and an additional seven have proposed to outright ban the drug.

While the FDA has loosened restrictions, England has taken the opposite tack. On Wednesday, England ended its pandemic policy that allowed for mail-in orders of mifepristone. The country restored its policy that women take the drug at a clinic or hospital. Data from the country showed that women were three times more likely to need an emergency ambulance when taking mifepristone at home rather than in a clinic.

Black market mifepristone providers have thrived as states enact more abortion restrictions. Texas followed its six-week abortion ban with a ban on mail-in orders for mifepristone and limited its use to seven weeks. Aid Access, an international mifepristone provider that was sent a cease and desist order by the FDA in 2019, reported a 1,000 percent increase in orders from Texas after the law went into effect. Women can apply online for the illegal Aid Access pills, which are prescribed by European doctors. The FDA under the Biden administration has yet to regulate Aid Access and did not respond to a request for comment.

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The upper chamber voted 50 to 46 to approve Dr. Robert Califf, who will serve as FDA commissioner for a second time after holding the position during the Obama administration from 2016 to 2017. Three Democrats—Sens. Richard Blumenthal (D., Conn.), Maggie Hassan (D., N.H.), and Ed Markey (D., Mass.)—joined Sanders and Manchin to vote against his confirmation. The group of Democrats criticized the Biden pick for his ties to the pharmaceutical industry and failure to effectively regulate opioids during his first stint at the FDA. Republicans, meanwhile, focused on Califf's efforts to deregulate chemical abortion pills, which have four times the complication rate of surgical abortions.

Republican senators Roy Blunt (Mo.), Richard Burr (N.C.), Susan Collins (Maine), Lisa Murkowski (Alaska), Mitt Romney (Utah), and Pat Toomey (Pa.) broke with their party and voted to confirm Califf.

Califf will take over the FDA as the agency focuses on opioid abuse and COVID-19 vaccines. Isolation amid the pandemic has led to skyrocketing drug overdoses, which surpassed 100,000 annually last year for the first time ever.

The FDA under Califf's leadership saw an all-time high in prescription opioid deaths. Manchin said the FDA's failure to effectively restrict opioid access will likely continue as Califf returns to the agency.

"Dr. Califf has shown us who he is, and he has shown a complete lack of interest in actually making the difficult decisions that we need the leader of the FDA to make," Manchin said Monday. "Nothing that Dr. Califf has said or done has led me to believe he will operate the FDA any differently than he did during his previous tenure."

As the founding director of the Duke Clinical Research Institute, Califf was a paid consultant for pharmaceutical companies such as Merck, Johnson & Johnson, GlaxoSmithKline, AstraZeneca, and Eli Lilly. Markey said Tuesday that Califf did not commit to necessary reforms of the pharmaceutical industry to counter opioid abuse.

Until 2016, the FDA required chemical abortion pill providers to report all adverse events, such as hemorrhages and ectopic pregnancies. The FDA under Califf altered its policy so companies were only required to report deaths to the agency.

The agency then cited its adverse events database for the drug to justify its December decision to end the in-person requirement to obtain a prescription. The FDA database does not require emergency rooms to report medical complications for women who take chemical abortion pills. When emergency rooms are taken into account, the rate of medical complications is as much as 10 times higher than in studies that exclude it.

Califf said he was not involved in the December ruling but added that the FDA makes decisions "based on the latest data and scientific principles."

Even though Califf tried to distance himself from the Biden administration's deregulation of abortion pills, Sen. Steve Daines (R., Mont.) said Califf's moves as FDA commissioner helped set the stage for the December decision.

"Califf showed blatant disregard for the unborn and for the health and safety of women and girls when he weakened safety and reporting requirements for a dangerous chemical abortion drug," Daines said prior to the vote.

In recent months, Sanders and Manchin have been bitter rivals within the Democratic caucus. The Vermont senator criticized his West Virginia colleague for refusing to support the multitrillion-dollar Build Back Better plan as well as controversial voting legislation.

The Senate approved Califf in 2016 with an 89-4 vote.

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The scoring system, used to determine who in the state qualifies for life-saving COVID treatments, no longer includes "BIPOC status" as a major driver of eligibility. Minnesota quietly updated its prioritization scheme on Jan. 11, one day after former Trump administration advisor Stephen Miller told Fox News that he was considering "legal action" against the state. Miller's organization, America First Legal, had already threatened to sue New York over that state's race-based triage scheme; the group on Wednesday added Minnesota and Utah to the list, calling their rationing policies "blatantly racist, unconstitutional, and immoral."

The Minnesota health department declined to answer questions about the change but said it was "constantly reviewing" its policies to ensure that "communities that have been disproportionately impacted by COVID-19 have the support and resources they need."

Amid the outrage, Utah also announced it would be "reevaluating" who is eligible for monoclonal antibodies. Though the Utah state health department told the Free Beacon that its initial scoring rubric was "outdated," a new rubric released Tuesday still gives "non-white race or Hispanic/Latinx" identity two points, more than hypertension or chronic pulmonary disease. The state did clarify that all individuals with "a severely immunocompromising condition" are "automatically eligible" for the treatment, a change from the previous guidelines.

So far, only New York has stood its ground. A spokesperson for the state's health department said there has been "no change to the guidance," which makes "non-white race or Hispanic/Latino ethnicity"—but not poverty or geography—a criterion for eligibility.

The prioritization schemes have their roots in guidance from the Food and Drug Administration, which listed race as a risk factor for severe COVID-19. "FDA's acknowledgment means that race and ethnicity alone, apart from other underlying health conditions, may be considered in determining eligibility for [monoclonal antibodies]," Minnesota's initial scheme read. Utah likewise interpreted the guidance to mean that "​​race and ethnicity may be considered when identifying patients most likely to benefit from this lifesaving treatment."

Senator Marco Rubio (R., Fla.) on Tuesday called on the FDA to "immediately update its guidance."

"Rationing life-saving drug treatments based on race and ethnicity is racist and un-American," Rubio told acting FDA commissioner Janet Woodcock. "One's race or ethnicity should not be the driving factor that decides whether or not you live."

The post Minnesota Backtracks on Racial Rationing of COVID Drugs appeared first on Washington Free Beacon.

These schemes have sparked widespread condemnation of the state governments implementing them. But the idea to use race to determine drug eligibility wasn’t hatched in local health departments; it came directly from the federal Food and Drug Administration.

When the FDA issued its emergency use authorizations for monoclonal antibodies and oral antivirals, it authorized them only for "high risk" patients—and issued guidance on what factors put patients at risk. One of those factors was race.

The FDA "fact sheet" for Sotrovimab, the only monoclonal antibody effective against the Omicron variant, states that "race or ethnicity" can "place individual patients at high risk for progression to severe COVID-19." The fact sheet for Paxlovid, Pfizer’s new antiviral pill, uses the Centers for Disease Control and Prevention’s definition of "high risk," which states that "systemic health and social inequities" have put minorities "at increased risk of getting sick and dying from COVID-19."

The guidance sheets are nonbinding and do not require clinicians to racially allocate the drugs. But states have nonetheless relied on them to justify race-based triage.

"The FDA has acknowledged that in addition to certain underlying health conditions, race and ethnicity ‘may also place individual patients at high risk for progression to severe COVID-19,’" Minnesota’s plan reads. "FDA's acknowledgment means that race and ethnicity alone, apart from other underlying health conditions, may be considered in determining eligibility for [monoclonal antibodies]."

Utah’s plan contains similar language. In a section on the "Ethical Justification for Using Race/Ethnicity in Patient Selection," it notes that the FDA  "specifically states that race and ethnicity may be considered when identifying patients most likely to benefit from this lifesaving treatment."

The FDA declined to comment on either state’s plan, saying only that "there are no limitations on the authorizations that would restrict their use in individuals based on race."

The triage plans are part of a broader push to rectify racial health disparities through race-conscious means. In March of last year, for example, two doctors at Brigham and Women’s Hospital in Boston outlined an "antiracist agenda for medicine" that involved "offering preferential care based on race." And last year, Vermont and New Hampshire both gave racial minorities priority access to the COVID-19 vaccine, resulting in at least one formal civil rights complaint against New Hampshire.

The trend has alarmed Roger Severino, the former civil rights director at the Department of Health and Human Services, who called racial preferences in medicine a "corrosive and grossly unfair" practice.

"Our civil rights laws are not suspended during a public health emergency," Severino said. "We should never deny someone life-saving health care because of the color of their skin."

The triage plans show how federal guidelines can encourage this sort of race discrimination. They also suggest that the FDA is making political judgments, not just scientific ones.

"They’re injecting politics into science," said a former senior HHS official. "That’s something the Trump administration was pilloried for allegedly doing."

One clear sign of that politicization, several legal and medical experts said, is the guidance’s double standard between race and sex. Men in the United States have proven to be about 60 percent more likely than women to die of the disease, according to research from the Brookings Institution, and within some age brackets the mortality gap is even larger.

But the FDA doesn’t list sex as a risk factor anywhere in its guidance. And while the Utah scheme does take it into account, the New York and Minnesota schemes do not. Nor do they or the FDA give any weight to geography and socioeconomic status, both of which are associated with COVID-19 mortality.

Instead, the triage plans give more weight to race than to many comorbidities. In Minnesota’s scoring system, "BIPOC status" is worth two points, whereas "hypertension in a patient 55 years and older" is worth just one.

In Utah’s scoring system, "Non-white race or Hispanic/Latinx ethnicity" is worth two points—the same amount as diabetes, obesity, and "severely immunocompromised"—while hypertension, congestive heart failure, chronic pulmonary disease, and "shortness of breath" count for one each.

Men do receive one extra point under the Utah scheme, on the grounds that "male gender is associated with increased risk of severe COVID-19." Nonbinary patients, the document says, "may choose to answer" questions about their gender identity "with that background information."

The Minnesota and Utah health departments did not respond to requests for comment.

Several legal experts told the Washington Free Beacon that the prioritization schemes amount to illegal race discrimination. "It’s certainly unconstitutional to use race in this way," said David Bernstein, a professor of constitutional law at George Mason University.

In his view, it’s also unwise. "We don’t have a lot of happy examples of countries that have used race as a medical criterion," Bernstein said.

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