"FDA increasingly approves drugs without conclusive proof they work." - PBS, 2018.
"One-Third Of New Drugs Had Safety Problems After FDA Approval." - NPR, 2017.
The FDA has a bipartisan trust issue.
The FDA's Record
Covering Up Fraud: In 2015, journalist Charles Seife exposed the FDA burying medical fraud: flawed data, tainted experiments, and drugs that should not have been approved. They hid this from the public, researchers, and doctors.
An example is an antibiotic called Ketek. In 2003 there were problems and fraud in the clinical trials, yet the FDA buried it. Congress could not get answers even after gruesome safety issues came to light.
Manipulating The Media: In 2016, Seife broke another story. The FDA required outlets to abandon their ability to report on stories honestly in exchange for exclusive and breaking stories. Reporters were told what they could and could not ask, and who they could and could not talk to.
CBS, NBC, CNN, NPR, Washington Post, Wall Street Journal, and the New York Times were all involved.
Protecting Pharmaceuticals Over People: In 2017, it became known (again thanks to Seife) the FDA withheld data about a controversial drug to protect the manufacturer, their reputation, and the stock price. The FDA appears to value corporations over the American people.
"Before releasing the documents, the agency allowed Sarepta (which is intervening in my lawsuit against the FDA) to suggest redactions that it felt would cause such harm or are exempt from release in other reasons." [Scientific American]
Documented History Of Failures: PBS covered how the FDA approved a drug for Parkinson's. Despite failing the first two clinical trials, it was approved. Later, it turned out that more patients on the drug died or had serious side effects than those without treatment.
Similarly, the FDA approved a gout drug with serious safety problems during the clinical process. After approval and mass usage, the drug's manufacturer reported that patients who used the drug were 34 percent more likely to die than those on other medications. Researchers at Yale School of Medicine found that it took a median of 4.2 years after approval for safety concerns to come to light.
There are countless similar stories.
The FDA Doesn't Regulate Anymore
Approving More, Rejecting Less: The FDA has increasingly approved more novel drugs and rejected less. It approved 46 novel drugs in 2017, the most in 15 years. In the same year, they rejected only 19.7% of applications for new drugs. That's down from a 2010 peak of almost 60% rejections.
"Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency." [PBS]
The FDA frequently approves drugs that European countries reject for insufficient evidence or safety concerns.
Paying Off Regulators: Physicians, caregivers, and others who testify before FDA panels that evaluate drugs get consulting fees or other payments from pharma companies.
A study found that nearly 40% of physician FDA advisers received more than $10,000 from drugmakers (or their competitors) which their panels voted to approve or decline. Nearly 25% received more than $100,000. Five percent received over $1 million.
“Instead of a regulator and a regulated industry, we now have a partnership” - Dr. Michael Carome, director of the nonprofit advocacy organization Public Citizen, and a former U.S. Department of Health and Human Services official.
Only Incentivizing Approvals: Teams at the FDA's Center for Drug Evaluation and Research get awards for approving drugs. It also brings promotions. There are no such incentives for rejecting drugs.
The FDA's Recent Approval Was Not About Public Health
With the FDA's Emergency Use Authorization, the Pfizer vaccine was already accessible to everyone. Approving it had nothing to do with protecting the public. It had everything to do with the following:
Pushing Profits: After approval, Pfizer shares went up. Purchases will follow. The same will happen to all other pharmaceutical companies whose drugs become approved. As mentioned earlier, FDA has displayed a pattern of prioritizing corporations over people.
Pushing Partisan Agendas: Joe Biden and his administration have been clear about vaccine mandates. They've pushed private businesses and the health industry to mandate vaccines. The biggest impediment to the administration's mandate has always been FDA approval.
Now, with FDA approval, the scene for widespread mandates has been set. Immediately after approval, a wave of mandates was issued. The mandates will require buying and administering more vaccines for the public, which will increase profits.
The partisan push doesn't swing one way. The Trump administration swayed the FDA into fast-tracking the vaccine and approving other drugs the administration pushed for, such as HQL. The FDA is an easily corrupt institution.
Avoiding Science: The FDA didn't need to approve the vaccines; it did nothing for public safety. Instead, they could have waited for Pfizer's long-term trial to finish. It's estimated to finish in 2023 and covers the long-term safety and efficacy of the shots.