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The FDA Has a History of Rushed Drug Approvals

FDA approved

Two weeks ago, the Pfizer COVID-19 vaccine was reported as the first COVID-19 vaccine to receive full approval from the U.S. Food and Drug Administration (FDA) for individuals aged 16 and older.1 But, for some, questions remain regarding conflicting discrepancies of the wording surrounding the approval.2 While the FDA’s report states that full approval was issued for the newly-named Comirnaty vaccine, it also states that the licensed Comirnaty vaccine and Emergency Use Authorization (EUA) Pfizer/BioNTech vaccine are “legally distinct with certain differences that do not impact safety or effectiveness” and that the two products may be used interchangeably.3

While this wording has left some to question, mainstream news sources are reporting that the two are indeed the same vaccine, and that the nuance stems from the fact that the vaccine is still under EUA for children between the ages of 12 and 15.4

As of now, no further clarification has been given from the FDA or U.S. Centers for Disease Control and Prevention (CDC).

FDA Commissioner Says Pfizer Vaccine Meets FDA’s Gold Standard for Safety

Prior to the announcement of FDA approval, over 92 million people had received the Pfizer vaccine which has been distributed under an EUA granted by the FDA to Pfizer/BioNTech since mid-December.5

During a briefing on Aug. 23, 2021, FDA Acting Commissioner Janet Woodcock, MD called the approval “a pivotal moment,” and said:

While this and other vaccines have met the FDA’s rigorous scientific standards for emergency use authorization, as the first FDA approved COVID-19 vaccine, the public can be confident that this vaccine meets the FDA’s gold standard for safety, effectiveness and manufacturing quality that we require for an approved product.5

The approval was received a little over a year after trials began in July 2020,6 less than nine months after receiving the EUA in December 2020,6 and less than 100 days after Pfizer submitted its biological license application.5 Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said that the FDA completed the approval process “in about 40 percent” of the time it would normally take an approval application submission “of this magnitude.”5 Historically, an experimental vaccine is in development for 10-15 years before receiving FDA approval for the general public.7

Original FDA Panel Members Excluded from Second Meeting

Four temporary FDA Advisory Committee members who raised concerns at a meeting in October were excluded from the panel meeting held two months later. Diana Zuckerman, PhD, president of the National Center for Health Research, said that it’s not unusual for temporary committee members to change, but that it was surprising since the issues being considered were the same at both meetings.

Dr. Zuckerman believes there is a possibility that the four experts may have been excluded to avoid the FDA having to publicly answer tough questions surrounding the data. One of those doctors was Michael Nelson, MD, who raised concerns about how vaccine effectiveness was being measured and stated that “more real-time data might be needed”. Dr. Nelson is the president of the American Board of Allergy and Immunology (ABAI) and a physician at Walter Reed Army National Military Medical Center in Bethesda, Maryland.8

For now, the FDA license only applies to individuals 16 years and older, but the vaccine is still available for those aged 12 to 15 under the EUA. Pfizer expects to have clinical trial data on five to 11 year old children this month and has said that data for two to five year children may be available shortly afterwards.5

 Following FDA Approval, Biden Administration Calls on Businesses to Require Employee Vaccinations

On the day Pfizer received FDA approval, President Joe Biden urged businesses, non-profits, and state leaders to mandate the vaccination. In an address to the nation, he stated:

Today I’m calling on more companies… in the private sector to step up the vaccine requirements that will reach millions more people. If you’re a business leader, a non-profit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that… do what I did last month, requiring employees to get vaccinated or face strict requirements.9

Last month, the Biden administration rolled out mandates for federal employees, members of the U.S. Armed Forces, federal medical facility employees, and nursing home employees.10

Poll Finds Majority of Americans Have General Mistrust of the FDA

While some “vaccine hesitant” individuals were awaiting FDA approval before getting the shots, many Americans have a general mistrust of public health organizations which may be holding them back from getting the vaccine. An NPR article from May 2021 published poll results indicating that only 37 percent of Americans have “a great deal of trust” in the FDA, and only 52 percent of Americans have “a great deal of trust” in the CDC.11

This mistrust may not come as a surprise to those familiar with longstanding scrutiny of public health entities. The FDA, for example, has come under criticism for the “revolving door” policy that exists between pharmaceutical company employees and the FDA.

Former FDA Commissioner Now Sits on Board of Directors for Pfizer

Former FDA commissioner Scott Gottlieb, MD is one of those employees who used to be in a high level position regulating vaccines, who now is a member of Pfizer’s board of directors. Prior to his appointment to FDA commissioner, Dr. Gottlieb worked as a consultant with several pharmaceutical companies.12 In the three-year span leading up to his job as commissioner, Dr. Gottlieb received a total of $559,000 from several drug and medical device companies. After serving as FDA commissioner for just under two years, he made an abrupt departure in 2019 stating he wanted to spend more time with his family.13 Public Citizen reports:

Such a rapid swing through the revolving door between the FDA Commissioner’s office and the pharmaceutical industry inevitably erodes public trust in one of the leading agencies of the Public Health Service.13

FDA Receives 45 Percent of Budget from Company User Fees

Additional criticism of the FDA stems from the funding the agency receives from the very companies it is charged to be monitoring and regulating. Up until the early 1990s, the FDA was entirely a taxpayer-funded federal agency responsible for regulating the pharmaceutical industry. In 1992, largely due to pressure on Congress from special interest groups wanting greater accessibility to experimental drugs to treat AIDS, Congress passed the Prescription Drug User Fee Act (PDUFA), signed into law by President George H.W. Bush.14

This act directed pharmaceutical companies to pay the FDA a fee to review drug and vaccine license applications and allowed manufacturers to pay annual user fees to fast track experimental drugs and vaccines to licensure. Of the FDA’s total budget, 45 percent comes from user fees, but 65 percent of the funding for drug regulations are derived from these fees.14 In 1987, it took 29 months for a drug to be approved following manufacturer filing. In 2014, it took only 13 months and in 2018, it took ten months. As application timelines have decreased, the number of medications removed from the market or with new black box warnings have increased from 21 percent prior to 1992, to 27 percent after the user fee was approved.14

While the PDUFA may have started as an innocent way to increase availability of experimental drugs for hard-to-manage diseases like AIDS, there are growing concerns about the advisability of compromising FDA’s first duty to protect the public and blurring the lines between consumer safety and corporate profitability.14 Michael Carome, MD, a former U.S. Department of Health and Human Services (HHS) official, stated:

Instead of a regulator and a regulated industry, we now have a partnership. That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.15

C. Michael White, a pharmacist and medication and dietary supplement safety researcher, voiced concerns about the potential for the FDA to become weak, ineffective, and unable to do its job or protecting citizens. He also said “there are some signs that the pendulum may be swinging too far in the direction of the manufacturers.”14

These “signs” referenced by White include the FDA’s refusal to release unfavorable research without the manufacturer’s permission, as well as FDA advisors who are paid by pharmaceutical companies. 16

Documents Reveal FDA Advisers Receive Financial Gain from Drug Companies

 Another hidden conflict of interest stems from FDA advisers who are receiving payments or other financial support from pharmaceutical companies. These advisors are meant to be the gatekeepers in determining approval of a drug based on safety and efficacy studies. An investigative article written in Science Mag found that of 107 physician FDA advisers voted on approval committees, 40 of them received more than $10,000 in post hoc earnings or research support, 26 of them received more than $100,000, and six received more than $1 million.17 These payments go unnoticed and entirely unregulated since the payments are not completed until after the advisory panel meets and the individuals declare they have no financial conflicts of interest. Science Mag reports:

In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28… drugs between 2008 and 2014, Science found widespread after-the-fact payments or research support to panel members. The agency’s safeguards against potential conflicts of interest are not designed to prevent such future financial ties.17

University of Minnesota medical ethicist Carl Elliott, MD has also stated that in addition to financial gain, further benefits such as jobs, professional prestige, and influence are also fraught within the industry.17

Pfizer Contributes $1M to Members of Congress, Almost $400,000 to President Biden

Lastly, the pharmaceutical industry has long been a major contributor to members of congress, specifically focusing on those on key committees that oversee healthcare legislation. In 2020, Pfizer contributed roughly $1 million to members of Congress. A Stat News article reported that last year, over two-thirds of Congress cashed a check from a pharmaceutical company. The article states:

The breadth of the spending highlights the drug industry’s continued clout in Washington. Even after years of criticism from Congress and the White House over high prices, it remains routine for the elected officials who regulate the health care industry to accept six-figure sums.18 19

FDA Senior Officials Resign Over Rushed Booster Shots

Last week, FDA senior officials Marion F. Gruber, PhD and Philip Krause, MD announced plans to resign from their positions over disagreements with the Biden administrations’ rush to approve COVID-19 booster shots. Administration officials have repeatedly vowed to listen to career scientists and are pushing for the COVID-19 booster shots to begin on Sept. 20. Drs. Gruber and Krause apparently disagree with the administration’s “aggressive” approach, arguing that there is not yet enough evidence to support a widespread distribution of boosters.20

Thomas Marciniak, MD, former FDA medical team leader and longtime critic of pharmaceutical company safety trials said:

You don’t survive as a senior official at the FDA unless you’re pro-industry. The FDA has to pay attention to what Congress tells them to do, and the industry will lobby to get somebody else in there if they don’t like you.15

 


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Click here to view References:

1 Guarino B, McGinley L, Pager T. Pfizer-BioNTech coronavirus vaccine gets full FDA approval, potentially persuading the hesitant to get the shot. The Washington Post Aug. 23, 2021.
2 Nass M. Here’s why no one can force you to take Pfizer’s newly ‘approved’ Comirnaty vaccine. The Defender Aug. 30, 2021.
3 U.S. Food & Drug Administration. Pfizer Aug. 23, 2021.
4 Camero K. Are Pfizer and Comirnaty the same? What to know about COVID vaccine name change. News Observer Aug. 26, 2021.
5 Howard J. FDA grants full approval toPfizer/BioNTech COVID-19 vaccine, opening door to more vaccine mandates. CNN Aug. 23, 2021.
6 Pfizer. About our landmark trial. Aug. 28, 2021.
7 Hendler C. Mandating a novel vaccine is a novel legal issue. The Vaccine Reaction June 7, 2021.
8 Hilzenrath D. FDA panel reviewing Pfizer vaccine leaves out some experts who raised concerns. POGO Dec. 9, 2020.
9 Rivas K. Biden urges businesses to mandate the COVID-19 vaccine following full approval of the Pfizer-BioNTech shot. Fox Business Aug. 24, 2021.
10 Hobley N. All members of the armed forces will be required to be vaccinated for Covid. The Vaccine Reaction Aug. 16, 2021.
11 Simmons-Duffin S. Poll finds public health has a trust problem. NPR May 13, 2021.
12 Thomas K. FDA nominee, paid millions by industry, says he’ll rescue himself if needed. The New York Times Mar. 29, 2017
13 Carome M. Outrage of the month: revolving door to FDA commissioner’s office sows distrust in agency. Public Citizen Oct. 2019.
14 White C. Why is the FDA funded in part by the companies it regulates? UConn Today Aug. 24, 2021.
15 Chen C. FDA repays industry by rushing risky drugs to market. ProPublica June 26, 2018.
16 Angell M. Taking back the FDA. Boston Globe Feb. 26, 2017
17 Piller C, You J. Hidden conflicts? Pharma payments to FDA adivsers after drug approvals spark ethical concerns. Science Mag July 5, 2021.
18 Facher L. More than two-thirds of Congress cashed a pharma campaign check in 2020, new STAT analysis shows. STAT News June 9, 2021.
19 OpenSecrets.org. Pfizer, Inc. Aug. 28, 2021.
20 Katz E. FDA’s two top career vaccine officials to step down. Government Executive Sept. 1, 2021.

7 Responses

  1. I say Congrats to Mr. Gruber & Dr. Krause for making the Right Decision …..based on the information they have. Hey, Follow the Money…..to Congress and the President….hmmm? But let’s face it…….they have No Clue about Health Prevention…..it’s all about Vaccines, and the money made off them. No one was told of any of the Side Effects of these Covid Vaccines…..until cases started showing up. And What compensation are these people getting for their long term Health problems? Have you seen any of the Commercials on T.V? Shingles Vaccine, HPV for your children, Whooping Cough Vaccines for Everyone……because it’s just not a Childhood Disease anymore. People have to Learn Preventative….but no one is teaching it anymore.

    1. It should be illegal to advertise prescription medicine on television. It’s disgusting and immoral the way they flood the airwaves with dangerous medicine solicitation, for business tax write offs.

  2. We need Officials like Krause ad Gruber standing there holding the line at the FDA. If we don’t have them, the FDA will only replace them with corrupt officials making the Agency more beholden to Industry. ironically the FDA’s Job is to protect the people who originally established the institution.

  3. Back in the 1980’s while attending a National Health Federation gathering in Orlando, Florida, one of the speakers referred the FDA as the Faster Death Association. These people don’t care about you. They prefer you just DIE. Its time to clean house in Washington, District of Corruption.

  4. So much to unpack in this article…

    “You can not negotiate with people whom say; what’s mine is mine, and what’s yours is negotiable.”

    “There is no greater objection than absence.”

    “FDA, the rubber stamp and the revolving door.”

    “All medicines are ‘safe and effective’, when companies make billions of dollars from them.”

    The last thing the government effectively regulated was lead and asbestos. It took them decades to unpack the error in approval judgments, and decades further for independent industry to clean up the mess. Covid vaccines will be no different. They form the safety narrative around preconceived conclusions. Rigorous safety testing is absent. You can’t find what you refuse to look for. I see the author may be a reader of Childrens Health Defense news, or has somehow picked up on their many talking points. Good, more people need to understand the systemic failures of regulatory approval mechanisms, the unavoidable conflicts of interests around every corner. Or as I like to say, the very last place we turn to for product safety advisement is the government. We did not just spend the last 20 years paying exorbitant costs for non gmo and organic food to turn around and inject synthetic substances directly into our bloodstream and alter fundamental mechanisms of our bodies natural immune system. This is all unnecessary, there are effective treatments, these idiots just refuse to acknowledge them. Because they’re safe, effective, off patent, and dirt cheap for anyone to get their hands on. Therein lies the problem.

    https://budesonideworks.com/got-covid/
    https://covid19criticalcare.com/ivermectin-in-covid-19/how-to-get-ivermectin/
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7943455/

    We’re not ‘vaccine hesitant’. We have simply decided we’re not taking this medical product. No means no, it does not mean anything else.

  5. Meets the “GOLD STANDARD”
    Does that mean it took gold to get FDA approval?
    The FDA didn’t make their decision based on data.
    1. Covid vaccine not tested on pregnant woman, immune compromise, or previous exposed.
    2. No data on alternative dosage, or time between jabs ??.
    3. High death rate, high adverse reaction rate.
    4. No long term effectiveness data.
    5. No long term adverse data.
    6. No longer effective in preventing COVID in Massachusetts.
    7. The vaccine death rate is higher than COVID in person under 30 years.

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