Tag: big pharma

FDA targets Hims & Hers, posts more than 100 letters to drugmakers

The Trump administration is cracking down on pharmaceutical advertising and they are specifically targeting telehealth companies that promote unofficial versions of weight loss medications.

More than 100 letters were posted by the Food and Drug Administration to drugmakers and online prescribing companies. Hims & Hers built a multibillion-dollar business around weight loss interventions. The letters warned the companies, including Hims & Hers, to remove “false and misleading ” promotional statements and advertising from their website.

Your claims imply that your products are the same as an FDA-approved product when they are not,” states the warning letter, dated Sept. 9.

Hims said Tuesday that it “looks forward to engaging with the FDA.”

“Our website and our customer-facing materials note that compounded treatments are not approved or evaluated by the FDA,” the company said in a statement.

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Sweeping Trump crackdown on misleading pharmaceutical ads is first in nearly 3 decades

In a landmark move, the Trump administration has launched a sweeping crackdown on misleading pharmaceutical advertisements, the first major enforcement effort since direct-to-consumer drug ads were legalized in 1997. 

FDA Commissioner Dr. Marty Makary recently spoke with Full Measure about the unprecedented effort, stating that the agency is sending “thousands” of enforcement letters targeting deceptive promotions across TV, social media, and online platforms. 

The U.S. is one of only two countries allowing such ads (the other is New Zealand). Makary says the commercials often downplay serious risks, present false information, or mislead viewers by showcasing happy, dancing patients. He says FDA enforcement has been notoriously lax for decades, with FDA violation letters to drug companies dropping from 130 annually in the late 1990s to zero in 2024. 

The new plan targets not just TV but also social media influencers and online pharmacies. 

A key focus is closing the “adequate provision loophole,” which allowed vaccine ads to skip disclosing any risks at all by listing them elsewhere, like on websites. 

Makary argues this violates regulations against misleading impressions, and the FDA is moving to eliminate it.

No comparable crackdowns on misleading drug ads have ever been launched. Many observers say that’s in part due to the pharmaceutical industry’s influence with members of Congress who get big money from drug companies. They also blame inaction on the media that benefits from all the money drug ads bring in and make them more likely to defend the industry and downplay or censor prescription drug risks and concerns.

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Trump cracks down on drug ads on TV, social media that he says mislead people

President Trump went after pharmaceutical companies Tuesday by accusing them of intentionally concealing dangerous side effects when marketing their drugs on TV and social media.

He sent roughly 100 cease and desist letters and thousands of warning letters to companies about their advertising.

He also granted broad authority to Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Marty Makary to rein in the companies and their social media influencers.

Among the measures pharmaceutical companies can take are increasing the amount of information about risks associated with the medicine in advertisements and actions to “ensure truthful and non-misleading information in direct-to-consumer prescription drug advertisements

The president hardened the government’s stance against Big Pharma with a proclamation he signed Tuesday in the Oval Office. He did not add new enforcement action but ordered the government to more stringently ramp up enforcement of existing regulations covering drug commercials.

“Our goal is to ensure that patients have proper information about drugs that have potential harms,” a senior administration official said. “I think people are seeing ads sometimes not even realizing that they’re pharmaceutical ads.”

The White House declined to say which companies or influencers would receive the letters, but the official referenced a weight loss drug commercial that ran during the Super Bowl and drew the ire of senators on both sides of the aisle.

Hims & Hers, a telehealth company, faced scrutiny from Sens. Richard J. Durbin, Illinois Democrat, and Roger Marshall, Kansas Republican, for an ad promoting the active ingredient in the weight loss drug Ozempic, but not the drug itself. The two senators said the TV ad “risks misleading patients by omitting any safety or side effect information.”

Under Federal Trade Commission guidelines, Hims & Hers did not have to provide side effect information because it did not advertise a specific drug or medication. Instead, it urged consumers to consult with a doctor, which was consistent with FTC regulations.

Drug advertising aimed at consumers has exploded since the FDA relaxed its policies in 1997. The loosening of restrictions allowed pharmaceutical companies to boast of health claims while disclosing only a drug’s “most important” health risks. Before the policy change, drug companies had to disclose a lengthy list of possible side effects or avoid identifying the purpose of the drug in the first place.

However, enforcement of those guidelines has slacked in recent years. The FDA typically sends roughly 100 letters yearly, taking drug companies to task for their advertising. However, in 2023, the FDA sent only one such letter and did not send any last year, according to the White House.

“There are also regulations that speak very clearly that an ad must present a fair balance of information … but despite these regulations, enforcement has been increasingly lax over recent years [compared with] in the past when ads were far less frequent,” the official said.

Prescription drug ads account for hundreds of billions of dollars in advertising dollars spent each year. Through this summer, prescription drug brands accounted for 24.4% of ad minutes across evening news programs on NBC, ABC, CBS, Fox News, MSNBC and CNN, according to data from iSpot, which tracks television advertising.

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Audience ERUPTS as Vaccine Lawsuit Expert Aaron Siri TORCHES Democrat Sen. Blumenthal for Pathetic Attempt to Discredit Him — After Siri Exposes Buried Study Showing Vaccinated Kids Face SKYROCKETING Chronic Illness Compared to Unvaccinated Peers

The Senate Homeland Security and Governmental Affairs Committee held a bombshell hearing Tuesday afternoon on how the corruption of “science” has manipulated vaccine policy, public perception, and parents’ choices.

Attorney Aaron Siri, managing partner at Siri & Glimstad LLP, dropped a nuclear truth bomb on the vaccine establishment, exposing how the government, medical elites, and Big Pharma buried damning data proving vaccinated children face far higher rates of chronic illness than their unvaccinated peers.

Siri testified that none of the clinical trials relied upon to license routine childhood vaccines on the CDC’s schedule ever proved the products safe before licensure due to glaring design flaws.

Worse, post-licensure monitoring is riddled with manipulation and “a priori” assumptions that vaccines are inherently safe, effectively corrupting the entire scientific process.

According to Siri, a team of respected researchers at Henry Ford Health in Detroit, led by Dr. Marcus Zervos, Division Head of Infectious Disease, undertook a massive vaccinated vs. unvaccinated birth cohort study involving 18,468 children enrolled between 2000 and 2016.

The results were devastating to the vaccine establishment:

  • Vaccinated children were 3.03 times more likely to develop allergic diseases.
  • 4.29 times more likely to develop asthma.
  • 5.53 times more likely to suffer neurodevelopmental disorders — including speech disorders and developmental delays.
  • 5.96 times more likely to develop autoimmune diseases.
  • Not a single case of ADHD, learning disability, or tics was found among the unvaccinated, while hundreds of cases existed among the vaccinated cohort

By age 10, only 43% of vaccinated children remained free of chronic disease — compared to 83% of unvaccinated children

Despite the study being well-designed and internally validated, the researchers refused to publish it, fearing career destruction. Dr. Lois Lamerato admitted she “did not want to make doctors uncomfortable,” while Dr. Zervos feared losing his job.

Siri blasted this blatant cover-up, warning that if the results had shown vaccines improving health outcomes, the study would have been published immediately. Instead, because the findings threatened the pharmaceutical-government alliance, the study was buried, leaving parents in the dark.

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Are Pregnant Women Being Told the Truth about Antidepressants?

Across the world, thousands of pregnant women are being prescribed antidepressants. Yet few are warned about the potential harms to their unborn babies.

That concern came to the forefront at a 2-hour expert panel convened last month by the US Food and Drug Administration (FDA), moderated by Dr Tracy Beth Høeg, the agency’s senior adviser for clinical sciences.

A lineup of doctors, scientists, and former regulators gathered to examine a thorny question: do selective serotonin reuptake inhibitors (SSRIs) cause more harm than good when used during pregnancy?

Their opinions were not unanimous, but all agreed on one striking fact—there are no “gold-standard” randomised trials that have addressed the issue.

Instead of sparking serious debate, the panel was savaged by the media. The ferocity of the reaction only highlighted how difficult it has become to speak honestly when the message challenges psychiatric drugs.

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RFK Jr: “We were lied to about everything”

In a Twitter (now X) thread, Children’s Health Defense picked out some highlights of ‘The President’s 2026 Health Care Agenda’ hearing held on 4 September 2024.  We have republished the thread below. 

You can watch the full Senate hearing on YouTube HERE and read the written statement submitted by Robert F. Kennedy, Jr. HERE.

RFK Jr.’s Senate testimony just broke the Internet: “We were lied to about everything.”

By Children’s Health Defense

Kennedy spent three hours exposing the truth about vaccines and autism, the CDC’s cover-up of vaccine injuries and why Trump just fired corrupt CDC leadership.  And he named names – he called out corrupt Senators to their faces for taking Pharma money.

First, RFK Jr. broke down the truth about Pharma’s covid-19 cover-up: “We were lied to about everything.”

Democrats accused him of “politicising” HHS – but he exposed that everything about Pharma’s covid narrative was a lie.

“The whole process was politicised.”

“We were lied to about natural immunity.”

“We were told again and again the vaccines would prevent transmission, they’d prevent infection.”

“It wasn’t true.”

“Probably the most famous scientist on ACIP was Martin Kulldorff from Harvard … and he criticised the covid booster mandates.”

“President Biden came in, he mandated it, and then he fired the two top health officials at FDA, Dr. Gruber and Dr. Krause,” for their refusal to bow to Covid orthodoxy.

Then, RFK Jr. held Senator Michael Bennet accountable for refusing to acknowledge covid-19 vaccine injuries.

“Are you saying, Senator, that the mRNA vaccine has never been associated with myocarditis or pericarditis in teenagers?”

Sen. Bennet: “I am simply trying to say that the people that you have put on that panel, after firing the entire …”

RFK: “You’re evading the question.”

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HHS Will Link Autism To Tylenol Use During Pregnancy, Wall Street Journal Reports

U.S. Health Secretary Robert F. Kennedy Jr. plans to announce that autism is linked to the use of Tylenol during pregnancy in a report expected to be released this month, The Wall Street Journal reported today.

The U.S. Department of Health and Human Services (HHS) will also likely suggest that low levels of the vitamin folate also contribute to autism. The report will propose that a form of folate called folic acid, or leucovorin, can be used to treat symptoms of the disorder, according to the WSJ.

Acetaminophen, the ingredient found in hundreds of prescription and over-the-counter medicines — including Tylenol products — is routinely recommended for fever reduction and the relief of mild to moderate pain. Pregnant women commonly take it.

The drug has long been linked to liver toxicity, and several studies over the last decade — including one published last month by researchers at Harvard Medical School — have found that children exposed to the drug during pregnancy may be more likely to develop neurodevelopmental disorders, including autism and attention-deficit/hyperactivity disorder or ADHD.

Shares of Tylenol, made by McNeil Consumer Healthcare, a division of Kenvue, declined nearly 11% Friday after the WSJ published its report.

“Nothing is more important to us than the health and safety of the people who use our products,” a Kenvue spokeswoman told the WSJ. “We have continuously evaluated the science and continue to believe there is no causal link between acetaminophen use during pregnancy and autism.”

The American College of Obstetricians and Gynecologists (ACOG) says Tylenol is safe to use in pregnancy. In 2021, as more evidence of the link was emerging, the organization published a statement opposing a consensus statement supported by a group of 91 scientists in the journal Nature Reviews Endocrinology. The scientists said that a growing body of research suggests that prenatal exposure to the drug may alter fetal development and increase the risks of neurodevelopmental, reproductive and urogenital disorders.

“ACOG and obstetrician-gynecologists across the country have always identified acetaminophen as one of the only safe pain relievers for pregnant individuals during pregnancy,” the pharmaceutical industry-sponsored medical organization insisted.

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REPORT: According to WSJ – RFK Jr. to Reveal Tylenol Use During Pregnancy and Having a Folate Deficiency Potentially Linked to Autism

Secretary Kennedy is going to release his findings on the vaccine link to autism later this month, possibly on or near September 25th.

This study has Democrats and Big Pharma very, very worried.

* * * * * * * * * *

Health and Human Services Secretary Robert F. Kennedy Jr. will reveal that Tylenol use during pregnancy and a folate deficiency may be linked to autism.

During a Cabinet meeting last week, HSS Secretary Robert F. Kennedy Jr. declared that his department has pinpointed “certain interventions” that are almost certainly causing autism in children.

President Trump pressed the issue head-on during the Cabinet meeting, calling the autism crisis “a tremendous horror show” devastating American families.

Kennedy stunned the room with the numbers. In 1970, he said, a massive Wisconsin study of 900,000 children found an autism rate of less than one in 10,000. Today, official numbers put autism at 1 in 31 children nationwide.

California reports that one in 19 children are diagnosed with autism.

According to The Wall Street Journal, Tylenol and having a folate deficiency are potentially linked to autism.

The Wall Street Journal reported:

Health Secretary Robert F. Kennedy Jr. plans to announce that pregnant women’s use of an over-the-counter pain medication is potentially linked to autism in a report that will also suggest a medicine derived from folate can be used to treat symptoms of the developmental disorder in some people, people familiar with the matter said.

The report, expected this month from the Department of Health and Human Services, is likely to highlight low levels of folate, an important vitamin, and Tylenol taken during pregnancy as well as other potential causes of autism, people familiar with the matter said.

Kennedy’s department also plans to pinpoint a form of folate known as folinic acid, or leucovorin, the people said, as a way to decrease the symptoms of autism, which affected roughly one in 31 eight-year-olds in the U.S. in 2022.

Tylenol, whose active ingredient is acetaminophen, is a widely used pain reliever, including by pregnant women. Some previous studies have indicated risks to fetal development, but others have found no association. The American College of Obstetricians and Gynecologists says it is safe to use in pregnancy, though it recommends pregnant women consult with their doctors before using it, as with all medicines.

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RFK Jr. vs. “The Science”: The Untold Story of Corporate Capture

The “scientist” on the left pushed COVID shots for babies, pregnant women, and backed mandates. RFK Jr. vs. “The Science”

The man on the right is trying to Make America Healthy Again.

The CDC has a corruption problem, and it’s been this way for decades.

And it all traces back to one quiet change that took place in 1983.

This information comes from the work of medical researcher A Midwestern Doctor. For all the sources and details, read the full report below.

Unmasking CDC Corruption: RFK’s Battle to Reform Public Health

RFK Jr. wants to Make America Healthy Again.

But don’t think his confirmation as HHS Secretary flipped a switch. What some people fail to realize is that he wasn’t suddenly given the power to do what he wants.

For one thing, the bureaucrats under him didn’t suddenly embrace MAHA.

In fact, the opposite happened.

And no agency has fought harder against reform than the CDC.

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RFK Jr. Says CDC Ordered Scientist to DESTROY Autism Data Linking Measles Vaccine to Black Children in 2002

During a stunning Senate hearing, HHS Secretary Robert F. Kennedy Jr. revealed that in the early 2000s, a senior CDC scientist was ordered to destroy data from an internal study that showed a staggering link between the MMR (measles, mumps, rubella) vaccine and autism risk in young Black boys.

In 2004, a CDC-backed case-control study in Atlanta compared 624 children with autism to 1,824 without, assessing whether timing of MMR vaccination (before vs. after 18 or 24 months) was linked to autism risk. It found no significant association.

While the 2004 study did not find a causal link, a later re-analysis of the same data received significant attention.

A 2014 study published in Translational Neurodegeneration re-examined the CDC’s dataset and claimed to find an increased autism risk among African American boys who received the MMR vaccine before 36 months of age.

According to the 2014 study, “The present study provides new epidemiologic evidence showing that African American males receiving the MMR vaccine prior to 24 months of age or 36 months of age are more likely to receive an autism diagnosis.”

According to RFK Jr., the findings were explosive:

“The data from that study showed that black boys who got the vaccine on time had a 260% greater chance of getting an autism diagnosis than children who waited,” Kennedy testified.

“The chief scientist on that, Dr. William Thompson, the Senior Vaccine Safety Scientist at CDC, was ordered to come into a room with four other co-authors by his boss, Frank DeStefano, who’s the head of the safety press, and ordered to destroy that data. Then they published it without that fact.”

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