Rocky Mountain Voice

Tag: FDA

Colorado Wins FDA Approval To Import Lower Cost Drugs From Canada
DENVER7, Approved, State

Colorado Wins FDA Approval To Import Lower Cost Drugs From Canada

By Jaclyn Allen | Denver7 Governor: program could save Coloradans up to $46 million over three years. DENVER — Colorado has won federal approval to import lower-cost prescription drugs from Canada, a move Gov. Jared Polis says could save residents as much as 60% on certain medications. “This is a big step in the fight to push back against big pharma and bring lower-cost prescription drugs to Coloradans,” Polis told Denver7's Jaclyn Allen in an interview Monday. “It ain’t over yet, but it’s a big step.” The U.S. Food and Drug Administration signed off on Colorado’s application after years of back-and-forth between the state and federal officials. Polis said the push began with legislation he signed in 2019 authorizing the Department of Health Care Policy...
From insider to critic: Ex-White House official questions public health orthodoxy
All Better, Approved, Commentary, National

From insider to critic: Ex-White House official questions public health orthodoxy

By Katy Talento | AllBetter Substack I kept Robert F. Kennedy Jr. out of the West Wing. Now I owe him an apology. It was 2017. We had hauled the CEOs of a bunch of pharmaceutical companies into the Oval Office so that President Trump could berate them about their drug prices. (Always a good time.) Somehow, the word “vaccine” came up in the conversation. When that happens in the president’s presence, then, now, last month, and probably next week, like clockwork, he always starts telling the same story. A woman who worked for him at the Trump Organization back in the day. Her two-year-old son, who was “perfect, beautiful, magnificent, flawless.” Then he got a shot and he was “just gone. Gone. Never the same. Beautiful boy. Then, just gone.” The CEOs all shrank back and tu...
Bipartisan Majority Opposes Animal Testing Yet Federal Funding Persists
Washington Examiner, Approved, Commentary, National

Bipartisan Majority Opposes Animal Testing Yet Federal Funding Persists

By Meghan Miller | Commentary, Washington Examiner After years of court hearings, investigations, open rescues, and protests, the notorious beagle breeding and research facility Ridglan Farms has finally agreed to release 1,500 dogs to rescue organizations. This is certainly a win for animals, but the era of animal testing is far from over, particularly because the federal government enables it. While the Left and Right don’t align on much these days, over 85% of Republicans and Democrats do agree animal testing should be phased out. Notable voices across the political spectrum, including Lara Trump, Tomi Lahren, Dave Portnoy, Jennifer Welch, and groups such as Democracy Now! have spoken out against Ridglan, unequivocally demonstrating both that the public...
Federal Indictment Fuels New Questions Over Federal Handling Of COVID Origins And Vaccine Risks
Just The News, Approved, National

Federal Indictment Fuels New Questions Over Federal Handling Of COVID Origins And Vaccine Risks

By Greg Piper | Just the News Indictment alleges quid pro quo between EcoHealth Alliance, Fauci senior advisor started with an "upper-mid tier" wine delivery. Sen. Johnson says FDA knew government database "masked" vaccine injuries, rejected transparency update. David Morens, senior advisor to former National Institute of Allergy and Infectious Diseases Director Anthony Fauci for 16 years, spent much of his career studying the threat of viral outbreaks posed by birds, especially when infections jump from wild fowl to poultry. Now he's facing the possibility of prison. The chickens have come home to roost for Morens, two years after congressional subpoenas exposed his avowed practice of circumventing the Freedom of Information Act to hide conversations ...
Pro Life Groups Push DOJ To To Back State Authority On Abortion Drugs
The Federalist, Approved, National

Pro Life Groups Push DOJ To To Back State Authority On Abortion Drugs

By Maisey Jefferson | The Federalist Dozens of pro-life groups sent a letter to U.S. Acting Attorney General Todd Blanche on Monday urging him to protect women and babies from deadly chemical abortion and “reverse the DOJ’s harmful stance of siding with the abortion drug industry.” The 78 signees, led by Susan B. Anthony Pro-Life America, noted that “pro-life states cannot meaningfully enforce their laws when FDA is siding with mail-order abortionists and DOJ is siding with abortion drug manufacturers.” Under the Biden administration, the FDA removed common-sense restrictions around mifepristone, such as requiring an in-person doctor’s visit before obtaining a prescription. The administration also ultimately leveraged the Covid-19 pan...
White House Links Tylenol in Pregnancy to Autism, Pushes New Treatment Path
National, Approved, Daily Wire

White House Links Tylenol in Pregnancy to Autism, Pushes New Treatment Path

By Amanda Prestigiacomo | Daily Wire Trump said Tylenol use during pregnancy is linked to increased risk of autism. On Monday, President Donald Trump and Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced findings into the concerning spike in national autism rates, labeling one medication as a potential cause of autism, and another as a potential treatment. It was announced that the use of acetaminophen during pregnancy is tied to an increased risk of autism. Acetaminophen is the active ingredient in Tylenol, one of the most widely used medications globally for pain relief and fever reduction. “Taking Tylenol is not good. I’ll say it. It’s not good,” Trump said, noting that it might be necessary if a pregnant woman spikes a very high fever. “There’s ...
FDA pulls the plug on COVID vaccine emergency use authorization
The Epoch Times, Approved, National

FDA pulls the plug on COVID vaccine emergency use authorization

By Zachary Stieber | The Epoch Times Health Secretary Robert F. Kennedy Jr announced the move on Aug. 27. Federal regulators have revoked emergency authorization for COVID-19 vaccines, according to Health Secretary Robert F. Kennedy Jr. “The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy, the head of the Department of Health and Human Services (HHS), said on X on Aug. 27. At the same time, the Food and Drug Administration has approved the Pfizer-BioNTech COVID-19 vaccine for older adults as well as children as young as 5 years of age who have at least one condition that officials say puts them at higher risk of severe COVID-19 outcomes, Pfizer said in a ...
“Failure to Warn”: Senate report uncovers vaccine risk cover-up under Biden
Approved, National, The National News Desk

“Failure to Warn”: Senate report uncovers vaccine risk cover-up under Biden

By Julia Varnier | The National News Desk (TNND) — A new report from the Senate Homeland Security Committee accuses federal health agencies of failing to adequately warn the public about potential side effects of the COVID-19 mRNA vaccines, particularly the risk of myocarditis in young men. The report suggests that the Biden administration downplayed these risks to avoid increasing vaccine hesitancy. Dr. Jordan Vaughn, President of the Microvascular Research Foundation, testified on Capitol Hill Wednesday, during the Permanent Subcommittee on Investigations' first hearing about the negative side effects of the COVID-19 vaccine, criticizing the decision by public health officials in 2021 not to issue a Health Alert Network message when increased risks from the COVID-19 vaccine be...
FDA will no longer recommend Covid vaccine boosters for healthy Americans under 65
Approved, National, National Review

FDA will no longer recommend Covid vaccine boosters for healthy Americans under 65

By James Lynch | National Review Federal regulators announced Tuesday a new regulatory policy for Covid-19 approvals designed to limit vaccine approvals to older Americans and those at serious risk from the virus. The FDA’s new policy will make seasonal Covid-19 vaccines available to the elderly and those with health conditions that put them at a greater risk of infection, but not for young adults and children who otherwise face little risk of suffering from debilitating Covid-19 symptoms. Food and Drug Administration Commissioner Dr. Marty Makary and Center for Biologics Evaluation and Research director Dr. Vinay Prasad unveiled the policy in a new paper published by the New England Journal of Medicine. READ THE FULL STORY AT THE NATIONAL REVIEW
Pharma giant seeks to join lawsuit against FDA over weight loss drugs 
Approved, National, THE HILL

Pharma giant seeks to join lawsuit against FDA over weight loss drugs 

By Joseph Choi  | The Hill Eli Lilly is seeking to end a lawsuit filed by a pharmacy trade group against the Food and Drug Administration (FDA) by joining as a defendant, stating it wants to end the “entitlement” some pharmacies have practiced in mass-marketing copies of its highly popular GLP-1 medications. The lawsuit in question concerns the FDA’s decision to officially declare the shortages of Mounjaro and Zepbound, both forms of the GLP-1 drug tirzepatide, to be over in October. The suit was filed by the Outsourcing Facilities Association (OFA), a trade group that represents 503B compounding pharmacies, seeking to overturn the FDA’s decision. After the suit was filed, the FDA temporarily paused to reconsider the declaration to end the shortage but ultimately reaffirmed its de...

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