Are vaccines poorly-tested because the US FDA is partly funded by Big Pharma?!
Take a look at the latest controversial claim by Vice Presidential candidate Nicole Shanahan, and find out what the facts really are!
Nicole Shanahan : Vaccines Poorly-Tested Because FDA Is Funded By Big Pharma!
Vice Presidential candidate, and Robert F. Kennedy Jr.‘s running mate, Nicole Shanahan just claimed or suggested (archive) that vaccines are poorly tested because the US FDA is partly funded by pharmaceutical companies!
Our only protection from poorly tested vaccines is our regulatory agencies like the FDA. Yet, 46% of the FDA’s total operating budget is funded by pharmaceutical companies. This is what is meant by AGENCY CAPTURE.
A Kennedy-Shanahan administration will end the rampant conflicts of interest in the regulation of the medicines and vaccines we need. We can reverse the explosion of chronic diseases in our population by demanding that drugs and vaccines undergo proper, long-term testing. We will make manufacturers responsible for the damage caused by their products, so they are again incentivized to make them as safe as possible.
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Truth : Vaccines Are Properly Tested Even Though FDA Is Funded By Big Pharma!
This is unfortunately more misinformation by the Vice Presidential candidate, and Robert F. Kennedy Jr.‘s running mate, and here are the reasons why…
Fact #1 : Vaccines Are Not Poorly Tested
Let me start by pointing out that there is no evidence that the FDA ever approved any “poorly-tested” vaccine. Nicole Shanahan certainly provided no evidence that the FDA has ever done that, although the insinuation appears to be that there is “rampant conflicts of interest” due to “AGENCY CAPTURE”.
Even the COVID-19 vaccines, which were accused of being “rushed”, underwent massive clinical trials, and were only approved after they were shown to be safe and effective. To date, there has been no evidence that those clinical trials were compromised in any way by the pharmaceutical industry’s funding of the US FDA.
Fact #2 : FDA User Fees Improve Efficiency
In her post, Nicole Shanahan shared a screenshot of an article titled Why is the FDA Funded in Part by the Companies It Regulates?, but oddly enough did not provide a direct link to the article itself.
Perhaps that’s because the May 2021 article by C. Michael White of the UConn School of Pharmacy explained how user fees have helped to improve efficiency at the US FDA.
Because of the additional funding generated by user fees and performance measures that the FDA has to meet, the FDA is quicker and more willing to discuss what it wants to see in an application with manufacturers. It also offers clearer guidance for manufacturers.
The author also pointed out that FDA user fees are “a viable way to shift some of the financial burden to manufacturers who stand to make money from the approval and sale of drugs in the lucrative U.S. market.”
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Fact #3 : User Fees Don’t Affect Regulations
The user fees that the US FDA charges go towards paying people and other related costs of assessing and either approving or denying new drugs, vaccines, and medical devices.
They don’t affect its review process, as the FDA explained in its article that has been around since October 2022:
For products where premarket review is required, there are standards for FDA product review that are written into law and that the agency follows regardless of the source of funding. The FDA’s work, high standards, and decisions are guided by science and focused on protecting and promoting the public health.
Importantly, there is no direct connection between a fee paid to submit an application and the review outcome for that application. The fees are not a “fee-for-service” payment. Rather, the user fees, including application fees, are authorized by Congress to help the FDA fund payroll and related costs to deliver on program goals.
User fees provide the FDA with supplemental resources for reviewing product applications based on the scientific and clinical evidence, and for conducting related activities.
While the agency strives to meet the review timeline goals established as a part of the user fee program agreements, the timeline does not force the FDA to decide on a product application before the agency’s work is complete. If additional work is necessary, the FDA continues working past the applicable goal date. The user fee performance goals anticipate this may happen and do not count on meeting the timeline 100% of the time.
Arguably, user fees help FDA improve its review of new drugs and vaccines, not the other way around.
Fact #4 : There Are Other Regulatory Agencies
I should point out that even if the US FDA is somehow compromised by its funding by pharmaceutical companies, there are other regulatory agencies in other countries like the European Medicines Agency (EMA), Health Canada, the Australian Therapeutic Goods Administration (TGA), the Japanese Ministry of Health, Labour, and Welfare (MHLW), etc.
Vaccines that are approved by the US FDA are only approved for use in the United States. They still need to undergo assessment by each country’s regulatory agency. All those foreign regulatory agencies are not funded by the pharmaceutical industry, and therefore, provide a kind of verification for the regulatory work done by the US FDA.
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Fact #5 : FDA User Fees Are Used For Specific Purposes
FDA also pointed out that it is required by law to spend user fees only on specific activities:
The FDA is required by law to spend user fee funds only on specified activities. For example, human prescription drug user fee funds can only be used for activities specified in the law, which include monitoring of research, review of human drug applications and post-market safety activities.
Similarly, medical device user fee funds can only be used for activities specified in the law, which include monitoring of research, review of device applications, and a defined set of post-market activities.
In short – FDA user fees are used to fund its critical regulatory and review activities, which would otherwise by paid for by taxpayers, instead of pharmaceutical companies.
Fact #6 : FDA User Fees Are Reauthorised By Congress
The user fees came about after the FDA was too slow in studying and approving experimental HIV drugs during the height of the AIDS crisis in the 1980s and early 1990s.
The US Congress then passed the Prescription Drug User Fee Act in 1992, which was signed into law by President George H.W. Bush. Since then, it has to be reauthorised every five years by Congress, before being signed into law by the President of the United States.
So even if the Kennedy-Shanahan administration does come to pass (which appears to be highly unlikely), it is highly unlikely that Congress would agree to provide additional funding to make up for the shortfall should user fees be eliminated.
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
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