Tag: fda

The Loosening of Rules on Informed Consent

On January 22, 2024, amendments to the Food and Drug Administration (FDA) regulations (21 CFR 50) covering Institutional Review Boards (IRBs) were finalized and implemented. The amendments added a new section 50.22 that allows for exceptions to informed consent requirements for minimal risk research. 

While the addition of section 50.22 harmonizes FDA IRB regulations with the Dept of Health and Human Services (DHHS) IRB regulations (known as the Common Rule: 45 CFR 46) that are administered by the Office for Human Research Protections (OHRP), the handling of the Covid shots over the past 3-4 years should raise red flags. 

Currently, I am chair of an IRB at a private-not-for-profit outpatient healthcare agency that does research in which vulnerable populations are recruited. As such, I’m well aware that the foundational documents from which the OHRP developed the regulatory framework under which IRBs operate are the Nuremberg Code and the Belmont Report. 

Back in October 2023, my first Brownstone post, Where is the Office for Human Research Protections, asked the question as to how the approval of a Phase 3 research pharmaceutical product (mRNA vaccines) could be done without the formal involvement of IRBs. Specifically, the Nuremberg Code, covering informed consent, and the Belmont Report, covering among other elements, bodily autonomy, which are foundational to oversight of human subject research, and the requirement for a data and safety monitoring plan were completely discarded. Was the OHRP consulted for its input, and if not, did anyone from OHRP express concern? Given that these protections were put in place in response to medical atrocities (the Holocaust and the Tuskegee experiments), you’d think that they’d be sacrosanct. Think again!

While not providing a direct answer to the question I posed, Debbie Lerman’s posts, Covid mRNA Vaccines Required No Safety Oversight and Covid mRNA Vaccines Required No Safety Oversight: Part Two, and Sasha Latypova’s post, EUA Countermeasures Are Neither Investigational nor Experimental, provided a detailed roadmap as to the actions that were actually taken in implementing Emergency Use Authorization (EUA) for the Covid shot. To me, the most significant finding was that the legality of using EUA in civilian populations is rather tenuous, at best. 

With the foregoing as a backdrop, let’s get into the nuts and bolts of the new FDA regulations, noting that in addition to being chair of an IRB, I am also a retired physician, who has been in the healthcare field for 50 years. This includes 19 years of direct patient care in a rural setting as a Board Certified Internist, 17 years of clinical research at a private-not-for-profit outpatient healthcare agency, and over 35 years of involvement in public health, and health systems infrastructure and administration. As such, I bring a breadth of training, knowledge, and experience to this matter that is fairly unique.

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CRIMINAL FDA DECLARES INFORMED CONSENT NULL AND VOID

If we’ve learned one thing over the last three years, it’s that abiding by centuries-old medical ethics, like asking questions, is what White Supremacists™ and domestic terrorists do.

Via the soon-to-be-memory-holed American Medical Association webpage on informed consent:

“Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.

The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention.”

That was then.

This is now, when respecting the Science™ requires that you shut your filthy masked mouth and do whatever corporate media news actors and Public Health™ technocrats tell you to do.

Via Federal Register:

“The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.”

Branch COVIDians surely don’t care about any of this, as they gave up long ago exercising their former right to be fully informed of medical experimentation risks anyway. In fact, they brag about their ignorance and apathy and doglike obedience as if they are virtues.

Listen to the New York NAACP lady explain:

“We must take the vaccine. Now, I’m going to tell you a personal story off script. So, today right after this I am going to have an infusion, and I’m going to have an infusion because I want to make sure that the cancer that was in my body does not return. I’m not asking what’s in the infusion, I’m not looking up all of the ingredients in the infusion, I am sticking out my arm and I am taking the infusion, and that’s what we have to do.” [seal-like clapping from the masked retards behind her]

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Hemp Industry Pushes Congress To Hold FDA Accountable With Hearing On CBD Regulation Inaction

A coalition of hemp industry organizations are calling on a House committee to hold a hearing addressing the ongoing lack of Food and Drug Administration (FDA) regulations for products made with constituents of the crop such as CBD.

In a letter addressed to House Energy and Commerce Committee leaders, 28 state and national  nonprofits focused on hemp and dietary supplements said that “the time for a hearing has never been riper” to examine regulatory pathways that FDA could enact to allow for the lawful marketing of hemp products for humans and animals.

“In the more than five years since the legalization of hemp through the 2018 Farm Bill, in spite of a designated annual appropriation, the FDA has taken no meaningful steps toward the regulation of hemp—whether it be animal feed or extracts for human consumption like CBD,” the groups said.

FDA said last year that, after an extensive review, it determined that it lacked necessary authority to establish regulations for the hemp and CBD market, stating that it will require additional congressional support.

“Meanwhile, thousands of unregulated products continue to be sold, causing great consumer confusion and advantaging bad actors via-a-vis good faith manufacturers who want to play by the rules and offer healthy products,” the letter says.

The House Energy and Commerce and Senate Health, Education, Labor and Pensions (HELP) Committee responded to FDA’s inaction last summer by putting out a Request for Information (RIF) from experts on the best path forward for regulating hemp, with hundreds of respondents sharing their perspective and recommendations.

“By now, your staff has had months to review and consider these recommendations,” the organizations said in the new letter, adding that “Energy & Commerce must weigh in for there to be meaningful action.”

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Why Some Activists Fear Marijuana Rescheduling: Responding To Former FDA Official’s Dismissal Of Our Concerns 

Politico recently published an extensive Q&A with Howard Sklamberg, a former top Food and Drug Administration (FDA) official who currently works at the law firm Arnold and Porter. Many advocates for legalization and restorative justice have concerns about the rescheduling of cannabis to a Schedule III substance—fears that Sklamberg believes are “alarmist and misguided.”

As a longtime advocate, I have to say that I don’t share that view. Honestly, I can’t believe Sklamberg said some of the things that he said—and I think the fears that we have are well-informed, reasoned and practical, if for no other reason than the worrying lack of transparency coming from regulatory agencies since rescheduling was recommended last year. We advocates are not always right, but our track record on drug policy is better than that of the policymakers and regulators who campaigned for, created and continued the so-called war on drugs.

Regulators, elected officials and their surrogates could benefit from hearing and taking seriously the other side: the concerns that advocates have about cannabis rescheduling. I’ve done my best to capture some of them below.

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Republicans investigate resignations of 2 FDA scientists after hasty launch of Covid boosters

The head of the House Energy and Commerce Committee, Cathy McMorris Rodgers (R-Washington); Subcommittee on Health Chair Brett Guthrie (R-Kentucky); and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), are looking into the resignations of two reputable FDA scientists. The scientists resigned in 2021 after hasty approval of Covid vaccine boosters.

The retirements of Dr. Marion Gruber, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research (CBER), and Dr. Philip Krause, deputy director of the office, were announced in late summer of 2021 by the agency. No mention was made about why Gruber and Krause were leaving the agency.

However, multiple news reports circulated that doctors Gruber and Krause were frustrated with the Biden administration’s plans to move forward with recommending COVID-19 booster shots without the scientists’ prior approval. In other reports, sources told Politico that the two officials were at odds with the FDA’s top vaccine official, Peter Marks, and were discontented over the roles of the CDC and its Advisory Committee on Immunization Practices in decisions that they believed should be handled by the FDA.

On behalf of the Health and Oversight Subcommittee Republicans, the members of Congress sent a letter to FDA commissioner Robert Califf, addressing their concerns.

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Industry group calls for FDA regulation of Kratom

Kratom, the tropical tree native to Southeast Asia, isn’t lawfully marketed in the U.S.— not as a drug product, a dietary supplement, or a food additive in conventional food. However, products prepared from kratom leaves are available in the U.S. through sales on the Internet and at brick-and-mortar stores. 

Kratom is often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal.

According to the American Kratom Association, the U.S. Food and Drug Administration is putting consumers at risk because it refuses to regulate kratom properly.  

Mac Haddow, the association’s senior fellow on public policy, says: “Since the FDA  treats all kratom products as the same, consumers have to navigate an increasingly complex marketplace alone.”

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FDA Weighs New Application To Approve MDMA As First-Ever Psychedelic Medicine For PTSD

A psychedelics-focused drug development company is officially asking the Food and Drug Administration (FDA) to review an application to approve MDMA as a prescription medication for the treatment of post-traumatic stress disorder (PTSD).

The MAPS Public Benefit Corporation (MAPS PBC) announced on Tuesday that it submitted the new drug application (NDA) to FDA, requesting an expedited review given that the agency previously designated the psychedelic as a breakthrough therapy.

If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with psychotherapy and other supportive services.

MAPS PBC, which is a wholly owned subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), said it provided FDA with copious scientific data derived from multiple clinical trials that supported the efficacy of MDMA as a therapeutic for moderate and severe PTSD.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” Amy Emerson, CEO of MAPS PBC, said in a press release.

“If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health,” she said.

MAPS published the results of a recent Phase 3 trial in the journal Nature in September, finding that MDMA “significantly attenuated PTSD symptomology versus placebo with therapy.”

FDA in 2017 designated MDMA as a “breakthrough therapy” based on previous MAPS-sponsored trials. In total, the organization says findings from 18 of its Phase 2 and Phase 3 trials formed the basis of the NDA submitted to FDA.

Because the agency has already recognized the significant therapeutic potential of the psychedelic, MAPS PBC asked it to grant their application a priority review. FDA has 60 days to decided whether it will accept the NDA and whether it will grant priority status for a six-month review or the standards 10-month review.

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FDA approves first use of CRISPR gene editing to treat sickle cell disease

The Food and Drug Administration (FDA) on Friday approved a new therapy for treating sickle cell disease, with this move also marking the first instance of CRISPR gene editing receiving approval from federal regulators.

The FDA approved two new treatments for sickle cell disease (SCD) on Friday, Casgevy and Lyfgenia.

Casgevy, also known as exa-cel, is developed through a partnership between Vertex Pharmaceuticals and CRISPR Therapeutics. The treatment involves taking a sickle cell patient’s own stem cells, editing them to create more fetal hemoglobin and transplanting them back into the individual.

When more fetal hemoglobin is produced, red blood cells don’t become “sickle” shaped, which is what causes the complications and pain associated with SCD. About 100,000 people in the U.S. have SCD, with the disease mostly affecting Black patients.

The FDA has approved the treatment for SCD patients 12 years old and up.

“Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need, and we are excited to advance the field especially for individuals whose lives have been severely disrupted by the disease by approving two cell-based gene therapies today,” Nicole Verdun, director of the FDA’s Office of Therapeutic Products, said in a statement.

A bone marrow transplant has long been the only curative treatment for SCD, with an ideal donor usually being a fully related sibling. There is, however, only a 1-in-4 chance that a sibling will be a match and most patients don’t have this option. Casgevy essentially makes a patient their own donor.

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Why Is the FDA Still Requiring Human or Animal Testing For New Drugs?

Congress unanimously passed the FDA Modernization Act 2.0 in December 2022. The law allows drug companies to find alternative methods of assessing their products, without testing them on animals or human beings.

The bill was sponsored by Sens. Rand Paul (R–Ky.) and Cory Booker (D–NH). Its goal was to speed up the drug approval process, and to let scientists experiment with approaches methods that are more humane than testing on live subjects. Reason‘s Elizabeth Nolan Brown aptly summarized the bill’s achievements, noting that “previously, all drugs in development were required to undergo animal studies before being tested in human trials. Now, drug companies will still have the option to start testing experimental drugs on animals, but they won’t have to.”

And yet the Food and Drug Administration (FDA) has not taken action to update the agency’s regulations.

“The FDA’s regulations related to animal testing no longer fully conform with applicable law,” writes Paul in a letter to FDA Commissioner Robert Califf.

Paul’s letter, obtained exclusively by Reason, was co-signed by Booker and several other senators from both parties. It notes that the FDA has previously spoken positively about moving away from animal testing. But companies currently submitting applications for drug approval still have to deal with FDA requirements that stipulate human or animal testing—at least on paper.

“These and other regulatory provisions no longer reflect the full scope of the governing statute and should therefore be updated as expeditiously as possible,” writes Paul.

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Top FDA Officials Accepted Jobs With Moderna After Playing Key Roles In The Licensure Of COVID-19 Vaccines

A new BMJ investigation reveals a “revolving door” between FDA officials tasked with regulating COVID-19 vaccines and the companies who manufacture them.

Two high-level regulatory officials with the U.S. Food and Drug Administration (FDA) involved in vaccine oversight accepted jobs at Moderna just months after signing off on the licensure of the company’s COVID-19 vaccine, according to a British Medical Journal (BMJ) investigation.

The report by Peter Doshi, associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ, reveals a long-standing revolving door between the FDA and pharmaceutical companies whose products it regulates and raises questions about the impartiality and independence of top FDA regulators.

Dr. Doran Fink is a “physician/scientist experienced in regulation and clinical development/licensure of vaccines and related biological products” and was deeply involved with vaccine regulation at the FDA for more than 12 years, according to his LinkedIn profile.

According to the BMJ report, Dr. Fink started his FDA career as a clinical reviewer in 2010 and “worked his way up” to Deputy Director of the Division of Vaccines and Related Product Applications within the FDA’s Office of Vaccines Research and Review, where he led a team of medical officers focused on infectious diseases and related biological projects.

During the COVID-19 pandemic, Dr. Fink was a prominent voice on COVID-19 vaccines and which population groups should receive them. He spoke on behalf of the FDA at numerous meetings held by the agency’s vaccine advisors who met to discuss whether to approve COVID-19 vaccines, change their composition, or authorize boosters.

Dr. Fink also presented at meetings held by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices—a group of health experts that develop recommendations on how to use vaccines—as the FDA’s “principal FDA ex officio representative.”

According to the BMJ report and Dr. Fink’s LinkedIn profile, Fink also served on the senior leadership team for COVID-19 vaccine review and policy activities in response to the COVID-19 public health emergency.

As part of his role, he advised vaccine manufacturers on vaccine development throughout the pandemic and coordinated “expedited review of regulatory submissions,” advised U.S. government stakeholders outside the FDA on COVID-19 vaccine science and development, and contributed to FDA guidance on the development, licensure, and emergency use authorization of COVID-19 vaccines.

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