Rocky Mountain Voice

Tag: FDA

“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...
Potential artificial red dye ban: Products that could be affected
Approved, Fox Business, National

Potential artificial red dye ban: Products that could be affected

By Daniella Genovese  | Fox Business A wide range of foods will be affected if the Food and Drug Administration (FDA) moves forward with plans to ban artificial red dye. According to the Eat Well Guide (EWG) Food Scores database, nearly 3,000 food products on the U.S. market contain red dye 3, including candy, certain brands of mashed potatoes, yellow rice and some medications. The list also includes a range of other foods, including breakfast cereals, beverages and baked goods.  The synthetic dye, also known as erythrosine, is an additive made from petroleum that gives foods and drinks a bright cherry-red color, according to the FDA. It is already banned in the European Union, and starting in January 2027, it will also be prohibited in foods sold or manufactured in California.  ...
Trump picks Dr. Marty Makary as Food and Drug Administration commissioner
Approved, Fox News, National

Trump picks Dr. Marty Makary as Food and Drug Administration commissioner

By Brie Stimson | Fox News President-elect Trump on Friday announced he is nominating Johns Hopkins School of Medicine professor Dr. Marty Makary for Food and Drug Administration (FDA) commissioner.  "I am very pleased to nominate Marty Makary MD, MPH, FACS, for FDA Commissioner," Trump said in a statement. "FDA has lost the trust of Americans, and has lost sight of its primary goal as a regulator. The Agency needs Dr. Marty Makary, a Highly Respected Johns Hopkins Surgical Oncologist and Health Policy Expert, to course-correct and refocus the Agency."  Makary’s nomination comes after Trump nominated Robert F. Kennedy, Jr. to lead the Department of Health and Human Services (HHS) to "Make America healthy again." READ THE FULL STORY AT FOX NEWS