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Don’t misinterpret FDA agreeing to dismiss lawsuit on ivermectin

Dorit Rubinstein Reiss, a UC Hastings Law Professor, critiques the FDA’s decision to settle a lawsuit demanding the removal of their anti-ivermectin statements. She argues the FDA should not have conceded to the misleading narrative that ivermectin is effective against COVID-19, emphasizing the importance of authority in issuing public health recommendations. The settlement has been misrepresented by anti-vaccine activists to challenge FDA’s credibility, despite their maintained stance that ivermectin is unsupported for treating COVID-19.

FDA unproven drug

Pressure on the FDA to approve an unproven drug

In a pressure campaign to sway the FDA, advocates seek approval for an unproven drug to treat a rare genetic disorder. Despite public outcry, the FDA refused to greenlight the drug after it failed to demonstrate efficacy in a small-scale trial. It’s crucial to balance emotion with evidence in evaluating drug effectiveness. The FDA should not be swayed by public pressure to approve potentially unsafe drugs.

COVID vaccine development process – how it compares to “normal”

The development process for COVID-19 vaccines was accelerated yet robust and thorough, maintaining rigorous safety and effectiveness standards. Efforts to speed up the process included enrolling over 100,000 patients worldwide, fast-tracking data analysis and regulatory reviews, and preparing manufacturing facilities. Despite the rapid pace, multiple independent agencies and expert groups ensured vaccine safety and effectiveness, making it nearly impossible for a harmful vaccine to reach the market. This process, vital in saving lives amidst the pandemic, still follow established protocols used in pre-pandemic vaccine development.

FDA CDC COVID-19 vaccines

FDA, CDC, and COVID-19 vaccines — who does what?

This article about the role of the CDC and FDA concerning COVID-19 vaccines was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

I write this right after the FDA expert advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously that the benefits of both Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children 6 months to 5 years of age outweigh their risks, clearing a smooth path for FDA to grant emergency use authorization (EUA) to these vaccines. I was asked about the division of labor between CDC and FDA on COVID-19 vaccines, and it seems like something worth setting out.

So this is a short post about the relative roles of the FDA and CDC in getting COVID-19 vaccines to people in the USA. It is not a full picture of how vaccines get to us; there is a lot more to that. I am not even going into the full requirement for approving or authorizing a vaccine; just who does what. But this piece of the puzzle can be useful by itself.

For those looking for a full description of the vaccine approval process, I recommend either the Skeptical Raptor’s post on that topic or the description by the Vaccine Education Center of the Children’s Hospital of Philadelphia.  

Read More »FDA, CDC, and COVID-19 vaccines — who does what?
big pharma drug development

Big Pharma drug development — it’s not as easy as everyone thinks it is

Doing what I do here, I always get the impression that many people think that Big Pharma drug development is relatively easy. Just invent a drug, test it on some people, and then call up the FDA to get approval to sell it. I know that supplement manufacturers would be so happy if they could do that.

The actual facts are that Big Pharma drug development is so expensive, complicated, time-consuming, and failure-prone that you have got to wonder why anyone would jump into this process. For some drug discoveries, people grow old waiting for final FDA approval.

The myths about Big Pharma drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias,  you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies) and does whatever it wants. But let’s look at the process of Big Pharma drug development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths from the facts about Big Pharma drug development.

I have written a similar article about vaccine development, but I wanted to have one that was more about all drugs, except vaccines. Vaccines, and other biological drugs, have slightly different development and regulatory pathways which are not used to bring a standard pharmaceutical to market.

Read More »Big Pharma drug development — it’s not as easy as everyone thinks it is
vaccine development process

Vaccine development process – how it’s usually done

Back before the world of the COVID-19 pandemic, the vaccine development process took a long time. Despite the nonsensical claims of the anti-vaccine zealots, the vaccine development process is robust and thorough. The safety and effectiveness of all of the pre-pandemic vaccines are settled science (read the article before you jump up and down screaming about “settled science”).  

However, the world of the COVID-19 pandemic meant that if we can save a few months or even years off the development timeline on a new COVID-19 vaccine, it could save hundreds of thousands, maybe millions, of lives.

Of course, much of the optimism comes from experts like Dr. Anthony Fauci, one of the few rational public health experts who are willing to speak up in Washington DC. Maybe he has seen some secret data only available only to him and Bill Gates that supports this optimism. Maybe he just is trying to be the national cheerleader for healthcare.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, like Dr. Peter Hotez, MD Ph.D., have expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the development process, along with the independent controls that make sure that all vaccines are safe and effective.

Read More »Vaccine development process – how it’s usually done