MHRA and regulatory

Gottlieb stepped down abruptly as the FDA chief in March this year, a role he had held since May 2017. Unlike his predecessors, who said drug pricing was not the purview of the FDA, Gottlieb waded into the intensifying debate about the high cost of medicines for U.S. consumers and had the agency actively looking into possible solutions. Gottlieb ran into fierce opposition from anti-regulation groups such as Americans for Tax Reform and former FDA officials, who said the agency's regulatory efforts would destroy thousands of jobs.

In an interview with former BlackRock advisor Edward Dowd on “RFK Jr. The Defender Podcast,” Robert F. Kennedy, Jr. and Dowd discussed why they believe COVID vaccine makers committed fraud, and government agencies know it.

The Centers for Disease Control and Prevention (CDC) has a track record of trying to hide its communications with representatives of pharmaceutical companies. ICAN has sued the agency in the past for this very conduct. Apparently, CDC has not learned its lesson because it is now trying to hide emails between Dr. Amanda Cohn, the former Executive Secretary of CDC’s Advisory Committee on Immunization Practices, and pharmaceutical companies.

ICAN attorneys and research staff watch every meeting of the FDA’s VRBPAC and the CDC’s ACIP. What is seen over the course of many meetings are the patterns and methods by which these agencies rig the approval process to achieve pre-determined outcomes. Now VRBPAC and ACIP are gearing up to pre-approve all future COVID-19 shots, regardless of formulation, with no additional clinical trials!

FDA Assigned Pfizer’s COVID Vaccine a License Number Months Prior to Actually Licensing It

On December 16, 2020, ICAN submitted a Freedom of Information Act (FOIA) request to the Centers for Disease Control and Prevention (CDC) which resulted in the production of an email showing the cozy relationship between Pfizer and the CDC official now heading up its COVID-19 Vaccine Task Force.

ICAN uncovers that the FDA deviated from long-standing protocols concerning vaccine safety for COVID-19 Vaccines.

EXCLUSIVE: Freedom of Information requests reveal that the UK medical regulator, like its Australian counterpart, never inspected the Pfizer vaccine study data.

(Washington, DC) – Judicial Watch announced today it received 57 pages of heavily redacted records from the U.S. Department of Health and Human Services (HHS) that show, just two days prior to FDA approval of the Pfizer-BioNTech COVID-19 vaccine, a discussion between U.S. and UK health regulators regarding the COVID shot and “anaphylaxis” with the regulators emphasizing their “mutual confidentiality agreement.”

Evidence of fraud within the regulatory system?

After months of enquiries, the FDA says it will not provide further comment on DNA contamination

Former TGA boss appointed to the board of Medicines Australia, hoping to advance "mRNA technology framework" in Australia.

After holding oversight roles for covid vaccines, two regulators from the US Food and Drug Administration went to work for Moderna. Peter Doshi reports The physician-scientist Doran Fink worked his way up at the Food and Drug Administration, with a focus on the regulation of vaccines. Starting as a clinical reviewer in 2010, he was promoted to lead medical officer in the FDA’s Office of Vaccines Research and Review, overseeing a small team of medical officers responsible for infectious diseases and related biological products. During the covid-19 pandemic Fink took on a public role, appearing in numerous FDA and Centers for Disease Control and Prevention advisory committee meetings to discuss covid vaccines and serving on the senior leadership team for covid vaccine review and policy activities. Part of his role was to engage vaccine manufacturers to advise on the development of vaccines during the pandemic. In mid-2020 Fink announced the FDA’s expectations for any covid vaccine that the agency would consider authorising, and he took part in the ultimate decision to license the Pfizer and Moderna vaccines. Fink’s LinkedIn profile states that he finished his role at the FDA in December 2022. Two months later he was working at Moderna, heading the translational medicine and early clinical development programme in infectious diseases. He is one of two regulators The BMJ has found to have recently moved to Moderna from the FDA’s Office of Vaccines Research and Review. Concerns about a “revolving door”—movement of people between the government and the private sector—have persisted for decades, with public confidence in the balance over the integrity of government decision making.1–3 Craig Holman, who serves as government affairs lobbyist for the consumer advocacy organisation Public Citizen, says that government service is fundamentally different from private sector work. Those in the public …

Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate? Maryanne Demasi investigates Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate. In 1992, the US Congress passed the Prescription Drug User Fee Act (PDUFA), allowing industry to fund the US Food and Drug Administration (FDA) directly through “user fees” intended to support the cost of swiftly reviewing drug applications. With the act, the FDA moved from a fully taxpayer funded entity to one supplemented by industry money. Net PDUFA fees collected have increased 30 fold—from around $29m in 1993 to $884m in 2016.1 In Europe, industry fees funded 20% of the new EU-wide regulator, the European Medicines Agency (EMA), in 1995. By 2010 that had risen to 75%; today it is 89%.2 In 2005 in the UK, the House of Commons’ health committee evaluated the influence of the drug industry on health policy, including the Medicines and Healthcare Products Regulatory Agency (MHRA).3 The committee was concerned that industry funding could lead the agency to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.” But nearly two decades on, little has changed, and industry funding of drug regulators has become the international norm. The BMJ asked six leading regulators, in Australia, Canada, Europe, Japan, the UK, and US, a series of questions about their funding, transparency in their decision making (and of data), and the rate at which new drugs are approved. We found that industry money permeates the globe’s leading regulators, raising questions about …