Tag Archive for: food and drug administration

My Submission to the FDA re Vaccines

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I was notified by a friend that an FDA advisory committee was accepting public comments (until midnight, Tuesday, the 26th of May, 2026) on vaccine composition. For details, see here. Below is what I submitted. If you are inspired to also make a submission, please do so!

Some Major FDA EUA/Approval Reforms Needed

1 – Based on what transpired with COVID-19, the FDA needs higher standards before giving an Emergency Use Authorization (EUA) or an official Approval for:

a) A vaccine (particularly when a reasonable therapeutic is available).

b) A therapeutic (e.g., remdesivir and molnupiravir should not have received EUAs).

2 – Some key elements of the higher standards that the FDA needs to adopt (for giving an EUA or an Approval, for a vaccine or a therapeutic):

a) A requirement that RCT (Randomized Control Trial) control groups must be given reasonable medical care (not zero treatment), as that is unethical and results in unscientific test results.

b) A requirement that all RCTs (and subsequently the FDA) publicize Absolute Risk — preferably, exclusively.

Note 1:This is consistent with an important FDA advisory publication. A key conclusion (see page 60) is that the public is: “unduly influenced when risk information is presented using a relative risk approach; this can result in suboptimal decisions. Thus, an absolute risk format should be used.”

Note 2: The CONSORT 2010 Statement — Updated Guidelines for Reporting Parallel Group Randomized Trials states: “… presentation of both absolute and relative effect sizes is recommended…”

b) A requirement that the absolute effectiveness (not relative effectiveness) conclusively demonstrate that the vaccine or therapeutic is a net societal benefit.

c) A minimum effectiveness should also be required (e.g., 50%) to be granted an EUA.

d) If, after an EUA is granted, subsequent scientific studies indicate that the efficacy rate appears to have gone below the minimum efficacy, then the FDA should promptly have a formal public hearing of its EUA. If the conclusion of the public hearing is that there is a reasonable likelihood that the efficacy now appears to be below the minimum required, the FDA should immediately revoke its EUA.

e) The FDA’s Fact Sheet for Healthcare Providers include a warning statement like:

“This EUA was granted after a very limited scientific assessment of this product for this medical condition. As a result, the FDA has a low confidence level regarding the efficacy or long-term safety of this product for this condition.”

f) The FDA’s Fact Sheet for Healthcare Providers include a warning statement that this is an experimental EUA product, so it is not appropriate for it to be mandated.

g) The FDA should prohibit any EUA recipient from advertising that their product is “safe and effective,” as neither has been scientifically adequately determined.

h) The FDA must be prohibited from granting an EUA based on a subset of any RCT results (e.g., like here).

3 – Considering that the majority of adults in the US have at least one chronic disease, the FDA needs to meaningfully address this reality (when giving an EUA or an Approval, for a vaccine or a therapeutic) by the following:

a) A requirement that RCTs must include a representative sample of chronic illness subjects in both testing and placebo groups for products seeking EUA or Approvals.

b) In ALL cases where “a” was not done, the FDA’s Fact Sheet for Healthcare Providers must specifically include a warning statement (necessary for informed consent) that testing was inadequately done on subjects who had a wide variety of other chronic ailments, so the consequences to recipients with those conditions is unknown, and may worsen (including death) when taking this EUA product.

4 – The FDA should be obligated to promptly develop and publicize regulations for Informed Consent regarding the public’s taking of EUAs. (These should be comparable to the FDA’s informed consent conditions for clinical trial subjects [which includes many pages of conditions and caveats: see here].) EUA product recipients should effectively be considered to be clinical trial subjects.

5 – Regarding off-label use (again in an emergency), the FDA should:

a) Make it allowable for medical practitioners to prescribe an off-label therapeutic for any condition, when the medical practitioner believes that there is reasonable scientific evidence of efficacy. (Note: The FDA’s website states that this is already the case, but the COVID-19 situation — e.g., with IVM and HCQ — indicates otherwise.)

b) Be prohibited from identifying an off-label therapeutic as not acceptable for a medical practitioner to prescribe for a condition, where the medical practitioner determines that there is reasonable scientific evidence of safety and effectiveness.

(This prior misleading FDA webpage convolutes self-medicating and/or humans using veterinary products [never advisable], with a medical practitioner prescribing IVM.)

c) Establish an alternative procedure to an EUA for repurposed (esp. non-patented) pharmaceuticals, where they temporarily receive the FDA’s blessing, while more comprehensive scientific testing is conducted. Not doing this would appear to be contrary to this statutory directive.

d) Have sizable funds specifically allocated and available to quickly pay for independent RCT testing of off-label options that have reasonable scientific evidence of their effectiveness and safety for a repurposed medical use.

(See 21 USC Chapter 9, Subchapter V: §355g. Utilizing real-world evidence.)

e) Have a Consumer Advocate who does nothing but promote non-patented, re-purposed drugs to the FDA for review (especially in an emergency).

©2026  All rights reserved.

Here is other information from this scientist that you might find interesting:

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I will consider posting reader submissions on Critical Thinking about my topics of interest.

My commentaries are my opinion about the material discussed therein, based on the information I have. If any readers have different information, please share it. If it is credible, I will be glad to reconsider my position.

Check out the Archives of this Critical Thinking substack.

C19Science.info is my one-page website that covers the lack of genuine Science behind our COVID-19 policies.

Election-Integrity.info is my one-page website that lists multiple major reports on the election integrity issue.

WiseEnergy.org is my multi-page website that discusses the Science (or lack thereof) behind our energy options.

Media Balance Newsletter: a free, twice-a-month newsletter that covers what the mainstream media does not do, on issues from climate to COVID, elections to education, renewables to religion, etc. Here are the Newsletter’s 2026 Archives. Please send me an email to get your free copy. When emailing me, please make sure to include your full name and the state where you live. (Of course, you can cancel the Media Balance Newsletter at any time!)

The New FDA is Now Asking for Public Comments about COVID Injections

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Critical Thinkers should reply. 

Although the verdict is not in yet, the new FDA is hopefully nothing like the old FDA. Here is a test case: Request for Public Comments regarding COVID-19 type injections (mRNA). Comments will be accepted from May 7 to May 23.

You can ignore all the official-looking material and just click on the blue “Comment” box in the upper left of the page. Answer some basic questions and submit your comments (and/or attach a document).

FYI, here are two relevant documents of mine I sent them:

  1. Some Major FDA EUA/Approval Reforms Needed, and 
  2. Some Scientific Observations about the Medical Establishment’s Handling of COVID-19 to Date.

Those (and a lot more) are on my COVID-19 page: C19Science.info.

Fingers crossed!

P.S. — Please pass this onto other interested citizens.

©2025 All rights reserved.

Here is other information from this scientist that you might find interesting:

I am now offering incentives for you to sign up new subscribers!

I also consider reader submissions on Critical Thinking on my topics of interest.

Check out the Archives of this Critical Thinking substack.

WiseEnergy.org: discusses the Science (or lack thereof) behind our energy options.

C19Science.info: covers the lack of genuine Science behind our COVID-19 policies.

Election-Integrity.info: multiple major reports on the election integrity issue.

Media Balance Newsletter: a free, twice-a-month newsletter that covers what the mainstream media does not do, on issues from COVID to climate, elections to education, renewables to religion, etc. Here are the Newsletter’s 2025 Archives. Please send me an email to get your free copy. When emailing me, please make sure to include your full name and the state where you live. (Of course, you can cancel the Media Balance Newsletter at any time – but why would you?

Former FDA Official Cozied Up To Activists Months Before Joining Them, Emails Show

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A former senior U.S. Food and Drug Administration (FDA) official hobnobbed with employees from an anti-tobacco nonprofit just months before coming on as the group’s CEO, emails show.

Kathy Crosby, who played a leading role in shaping public health policy while serving as the director of Health Communication and Education at the FDA’s Center for Tobacco Products, became the president and CEO of the Truth Initiative, an anti-tobacco and anti-nicotine activist organization, in August 2023.

Prior to her exit from the FDA, emails obtained by the Functional Government Initiative (FGI) and exclusively shared with the Daily Caller News Foundation show Crosby hobnobbing with Truth Initiative employees and even corresponding with the group’s then CEO about setting up a meeting. 

“The emails the Daily Caller showed us raise some serious red flags,” Michael Chamberlain, director of the nonpartisan watchdog group Protect the Public’s Trust, told the DCNF.

“A federal employee is prohibited from accepting gifts, including comped tickets to conferences and galas, that are offered to her because of her status as a federal employee,” Chamberlain said. “That Ms. Crosby appears to have solicited the invitation to the gala she attended compounds the problematic nature of this episode. That she may have leveraged the event as an opportunity to seek outside employment is icing on the cake.”

Federal employees are barred both from soliciting gifts “to be given because of the employee’s official position” as well as from accepting those gifts. Additionally, they are prohibited from using their office for “private gain.” FDA employees are also barred from “seeking or negotiating for employment, that conflict with official Government duties and responsibilities.”

In April 2022, the Campaign for Tobacco-free Kids (CTFK) offered Crosby free tickets to its 2022 gala. Crosby was busy that year, so she declined the tickets but asked CTFK to “keep [her] in mind for next year’s event.”

Roughly a year later, Crosby responded to the same email thread and asked the CTFK if it would be “extending an invitation to any FDA colleagues to attend” the 2023 gala. Hours later, the organization offered Crosby complimentary tickets, which she then accepted, saying that she “should definitely be able to join” them this year.

Emails show that Crosby indeed attended the May 18, 2023, CTFK gala and networked with employees of the Truth Initiative while there.

Shortly after attending CTFK’s gala, Crosby emailed then-Truth Initiative president and CEO Robin Koval on May 22 to schedule a meeting so the two could “catch-up.” In the email, she also mentioned that she had already met with Howard Koh, a member of the organization’s board of directors, and other staff at the gala. Koval and Crosby ultimately agreed to meet on May 24, 2023.

“There’s a reason taxpayers are troubled by incestuous relationships between government agencies and activist groups and public health agencies are proving to be no exception,” Functional Government Initiative spokesperson Peter McGinnis said.

“These activist groups have business before the agencies—we know, for example, that [Trust Initiative] lobbies the FDA to increase fines on tobacco product manufacturers and sellers, while also spending millions to advocate for new product bans,” McGinnis continued. “It’s a coup for [Trust Initiative] to land a CEO who knows her way around the FDA, and it’s a lucrative jump for Ms. Crosby.”

On Aug. 15, 2023, Truth Initiative’s board announced its appointment of Crosby as the group’s president and CEO. Following the announcement, and while Crosby was still at the FDA, multiple Truth Initiative employees reached out via email to congratulate her.

“I just wanted to reach out and send a note to say congratulations,” one email from the group’s vice president of communications, Sarah Shank, reads. “It’s always a pleasure working with you and your team at FDA and I’m beyond thrilled to work with you in this new capacity here at Truth Initiative.”

“So excited for this next chapter with our organization,” Tina Morgan, the organization’s vice president of sponsorships, said.

Truth Initiative and Crosby didn’t respond to requests for comment.

“During Kathy Crosby’s 12 years as the Director for CTP’s Office of Health Communication and Education, she frequently communicated via email, phone calls, and in-person meetings with a wide range of stakeholders, including those from national public health organizations, industry, media, and state/local organizations,” an FDA spokesperson told the DCNF.

Crosby “immediately” notified the FDA that she was looking for a job outside the government and “recused herself from any official actions that would financially impact her future employer,” the spokesperson said, adding that Crosby’s attendance at the gala was also “reviewed and approved by FDA ethics officials” prior to the event.

In 2022, the Truth Initiative was hard at work attempting to influence policy through the FDA and other federal agencies.

According to the nonprofit’s 2022 annual report, they submitted 14 comments to federal agencies, provided “policy analyses and research” to inform FDA policymaking, urged the FDA to act against popular synthetic nicotine products, like ZYN, and recruited youth activists to submit comments to the FDA regarding its proposed rule to remove flavored cigars and menthol cigarettes from the market.

During her time at the FDA, Crosby was involved in crafting health warnings for cigarette packages and advertisements, formulating marketing restrictions for new tobacco products and shaping national policy broadly, according to her Truth Initiative biography.

Crosby spearheaded “public education and regulatory communication programs” which aided the federal government in successfully implementing the Tobacco Control Act, which regulates how tobacco products can be marketed.

AUTHOR

ROBERT SCHMAD

Contributor.

RELATED ARTICLE: Activist Group’s Leader Declines To Participate In House Hearing On Her Org’s Alleged Influence Over Biden Admin

EDITORS NOTE: This Daily Caller column is republished with permission. ©All rights reserved.

All content created by the Daily Caller News Foundation, an independent and nonpartisan newswire service, is available without charge to any legitimate news publisher that can provide a large audience. All republished articles must include our logo, our reporter’s byline and their DCNF affiliation. For any questions about our guidelines or partnering with us, please contact licensing@dailycallernewsfoundation.org.

Rep. Massie, Judiciary Committee Launch Probe Into Reports Biden Admin Pressured FDA Over COVID Booster Approval

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Republican Kentucky Rep. Thomas Massie sent letters Monday to senior Food and Drug Administration (FDA) vaccine officials, letting them know the House Judiciary Committee will be investigating allegations the Biden administration interfered in the FDA’s authorization and licensure of the COVID-19 vaccines.

The Daily Caller first obtained the letters to Dr. Marion Gruber and Dr. Philip Krause, both of whom resigned following President Joe Biden’s announcement in August 2021 calling for adults to receive a COVID-19 booster shot, which Massie says “put undue pressure on FDA health officials to quickly authorize the vaccinations.”

Gruber serves as the Vice President of Public Health and Regulatory Science at the International AIDS Vaccine Initiative. Philip Krause sits on the Board of Directors of Mesoblast, Inc. Gruber had been with the FDA for 32 years and Krause had worked at the agency for over a decade.

In the letters, Massie calls for records and materials relating to: 1. The FDA’s review, authorization, approval and/or promotion of all COVID-19 vaccines and boosters; 2. The departure of Dr. Marion Gruber and Dr. Philip Krause from the FDA’s Office of Vaccines Research and Review (OVRR); and 3. The identities of current or former employees who worked in the FDA’s OVRR for the period of Jan. 1, 2020, to the present.

“The Committee on the Judiciary is investigating allegations that the Biden Administration interfered in the U.S. Food and Drug Administration’s (FDA) authorization and licensure of the COVID-19 vaccines,” Massie wrote in the letter to the FDA.

“Dr. Gruber and Dr. Krause reportedly felt that the White House was getting ahead of the FDA on booster shots and disagreed with the Centers for Disease Control and Prevention’s (CDC) involvement in FDA decisions. You replaced Dr. Gruber as acting director of the FDA’s Office of Vaccines Research and Review (OVRR). Accordingly, we believe that you possess information relating to this matter, and we request your assistance with our inquiry,” he added.

READ THE LETTERS HERE: 

(DAILY CALLER OBTAINED) — … by Henry Rodgers

(DAILY CALLER OBTAINED) — … by Henry Rodgers

“Congress has an obligation to examine these facts to understand the sufficiency of existing federal statutes and to assess the Executive Branch’s execution of these statutes. Pursuant to the Rules of the House of Representatives, the Committee on the Judiciary has jurisdiction to conduct oversight of matters concerning ‘civil liberties’ and ‘administrative practice and procedures’ to inform potential legislative reforms,” Massie added.

The Caller contacted the FDA, Mesoblast, Inc. and the International AIDS Vaccine Initiative about the letters, to which they did not immediately respond.

AUTHOR

HENRY RODGERS

Chief national correspondent. Follow Henry Rodgers On Twitter

RELATED TWEET:

RELATED ARTICLE: Two Top Vaccine Officials Resign From FDA Amid Political Pressure From Biden Administration

EDITORS NOTE: This Daily Caller column is republished with permission. ©All rights reserved.

All content created by the Daily Caller News Foundation, an independent and nonpartisan newswire service, is available without charge to any legitimate news publisher that can provide a large audience. All republished articles must include our logo, our reporter’s byline and their DCNF affiliation. For any questions about our guidelines or partnering with us, please contact licensing@dailycallernewsfoundation.org.

Here’s How Much The Federal Government Has Spent Studying Impact Of Sex Change Meds We’re Already Giving Kids

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The National Institutes of Health (NIH) spent at least $17,576,200 since 2008 researching the impact of puberty blockers and cross-sex hormones, NIH records show, drugs that are already widely administered to children who identity as transgender.

Researchers used NIH funds to study the impact these medications have on bone density and strength, reproduction, immunity, cardiometabolism and mental health, along with several other issues. Most of these grants were issued after 2017 as interest in the subject grew, although some date back as early as 2008.

Although researchers are still learning about the long-term effects of these drugs and whether they actually help reduce depression and suicide rates for youths, they are already widely administered to children who identify as transgender; the Gender Identity Development Service at Tavistock in the U.K., the largest pediatric gender clinic in the world, has referred about 1,000 patients to endocrinologists to be assessed for puberty blockers, a spokesperson told the Daily Caller News Foundation.

The NIH gave the Children’s Hospital Los Angeles more than $7.7 million in grants for a project studying the impact of puberty-blocking drugs and cross-sex hormones on children as young as 8, according to various documents reviewed by the DCNF.

The study aims to determine whether early medical interventions for youths reduce the health issues that disproportionately impact transgender people, including anxiety, depression, substance abuse and suicide. Researchers observed 391 patients aged 8 to 20 at the Children’s Hospital Los Angeles, the Ann & Robert H. Lurie Children’s Hospital of Chicago and the Benioff Children’s Hospital; 90 went on puberty blockers and 301 went on cross-sex hormones, researchers reported.

“Ultimately, we aim to understand if early medical intervention reduces the health disparities well known to disproportionately affect transgender individuals across their lifespan,” researchers wrote. “The lack of data supporting medical interventions for transgender youth, combined with a shortage of providers knowledgeable of the complex psychosocial risk factors facing these young people, contributes to a health disparity and public health crisis of considerable magnitude.”

An activist who goes by Billboard Chris drew attention to the NIH grants online, highlighting the young age of some of the participants in this taxpayer-funded study.

Researchers in this observational study have been collecting data on existing models of care for trans-identified youths for about a decade in response to an Institute of Medicine report calling for further research on the subject, according to the study. The NIH contributed $7,748,467 to the Children’s Hospital Los Angeles in several separate grants for this project since 2015, according to the NIH website.

When undergoing medical sex change procedures beginning at an early age, children are administered puberty-blocking drugs then eventually put on cross-sex hormones such as testosterone or estrogen. The FDA has warned of a possible link between puberty-blocking drugs and serious symptoms like vision loss, and researchers in this study note the link between the drug and diminished bone density.

The drugs that are used to halt healthy puberty for transgender children have an official on-label purpose of delaying precocious puberty in young children, and they have also been used to chemically castrate sex offenders. Marci Bowers, a famous transgender surgeon, has publicly admitted that “every single child who was truly blocked at Tanner stage 2 [around 9 to 11 years old] has never experienced orgasm.”

Activists and medical professionals justify the administration of these drugs to children by claiming that, without them, transgender youths will commit suicide. Researchers have said that receiving these treatments in youth can reduce the risk of suicide and depression in numerous methodologically flawed studies which failed to control for confounding variables, failed to find causality and in some cases were funded by transgender activists groups and pharmaceutical companies that produce the drugs themselves, according to multiple DCNF investigations.

The DCNF calculated the sums of grants the NIH gave for projects specifically examining the effects of medications administered as part of the gender transition process; its funding of transgender-related research generally is far more expansive.

The NIH, the project’s contacts and the Children’s Hospital Los Angeles did not respond to the DCNF’s requests for comment.

AUTHOR

LAUREL DUGGAN

Social issues and cultural reporter.

RELATEDARTICLES:

Michigan Public School Appears To Hide ‘Gender Support Plans’ From Students’ Parents

California becomes sanctuary state for medical gender transition for kids, teens

Yes, Doctors Are Performing Sex Change Surgeries On Kids

EDITORS NOTE: This Daily Caller column is republished with permission. ©All rights reserved. Content created by The Daily Caller News Foundation is available without charge to any eligible news publisher that can provide a large audience. For licensing opportunities of our original content, please contact licensing@dailycallernewsfoundation.org.